MedWatch - August 2007 Safety-Related Drug Labeling Changes

HHS Log--links to Department of Health and Human Services website

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2007

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Actos (pioglitazone hydrochloride) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Cardiac Failure and Other Cardiac Effects Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) PRECAUTIONS Edema ...Since thiazolidinediones, including Actos, can cause fluid retention, which can exacerbate or lead to congestive heart failure, Actos should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure...	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including Actos, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of Actos, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of Actos must be considered. Actos is not recommended in patients with symptomatic heart failure. Initiation of Actos in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Actos in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... WARNINGS: Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Actos must be considered (see BOXED WARNING). Patients with NYHA Class III and IV cardiac status were not studied during pre-approval clinical trials and Actos is not recommended in these patients... WARNINGS: Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) ...In patients treated with an insulin-containing regimen at baseline, the incidence of serious heart failure was 6.3% (n=54/864) with Actos and 5.2% (n=47/896) with placebo. For those patients treated with a sulfonylurea-containing regimen at baseline, the incidence of serious heart failure was 5.8% (n=94/1624) with Actos and 4.4% (n=71/1626) with placebo.

Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Rosiglitazone maleate Cardiac Failure and Other Cardiac Effects	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Rosiglitazone maleate). After initiation of Avandamet, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandamet must be considered. Avandamet is not recommended in patients with symptomatic heart failure. Initiation of Avandamet in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Avandamet in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... WARNINGS: Rosiglitazone maleate/Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING). Avandamet should be discontinued if any deterioration in cardiac status occurs...

Avandaryl (rosiglitazone maleate and glimepiride) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Rosiglitazone Cardiac Failure and Other Cardiac Effects	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Rosiglitazone). After initiation of Avandaryl, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandaryl must be considered. Avandaryl is not recommended in patients with symptomatic heart failure. Initiation of Avandaryl in patients with established NYHA Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Avandaryl in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING)... WARNINGS: Rosiglitazone/Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING)...

Avandia (rosiglitazone maleate) Tablets Prescribing Information See MedWatch Safety Alert posted 08/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Cardiac Failure and Other Cardiac Effects	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of Avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandia must be considered. Avandia is not recommended in patients with symptomatic heart failure. Initiation of Avandia in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... CONTRAINDICATIONS Initiation of Avandia in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated (see BOXED WARNING)... WARNINGS: Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone must be considered (see BOXED WARNING)...

Celexa (citalopram hydrobromide) Tablets and Oral Solution Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Celexa... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Cymbalta... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Diovan (valsartan) Tablets Prescribing Information	BOXED WARNING Use in Pregnancy WARNINGS Fetal/Neonatal Morbidity and Mortality PRECAUTIONS Information for Patients Pregnancy Female patients of childbearing age should be told about the consequences of exposure to drugs that act on the renin-angiotensin system. Discuss other treatment options with female patients planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.	BOXED WARNING: Use in Pregnancy When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus... WARNINGS: Fetal/Neonatal Morbidity and Mortality ...In addition, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin-angiotensin system, has been associated with a potential risk of birth defects in retrospective data. Healthcare professionals that prescribe drugs acting directly on the renin-angiotensin system should counsel women of childbearing potential about the potential risks of these agents during pregnancy...

Effexor (venlafaxine hydrochloride) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Effexor... Drug Interactions Drugs Metabolized by Cytochrome P450 Isoenzymes Metoprolol MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Effexor XR... Drug Interactions Drugs Metabolized by Cytochrome P450 Isoenzymes Metoprolol MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor XR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Lexapro (escitalopram oxalate) Tablets and Oral Solution Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Lexapro... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Limbitrol (chlordiazepoxide) (amitriptyline HCI) DS (double strength) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Limbitrol... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illness, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Marplan (isocarboxazid) Tablets Contact Validus Pharmaceuticals at 1-866-9VALIDUS for current prescribing information. Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS TO PHYSICIANS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medications, Depression and other Serious Mental Illness, and Suicidal Thoughts and Actions" is available for Marplan... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Marplan or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk Contact Validus Pharmaceuticals for revised labeling.

Nardil (phenelzine sulfate tablets, USP) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Nardil... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Nardil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Parnate (tranylcypromine sulfate) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS TO PHYSICIANS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Parnate... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Parnate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS TO PHYSICIANS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Paxil... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or action? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Paxil CR... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or action? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil CR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Pexeva (paroxetine mesylate) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Pexeva (paroxetine mesylate)... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Pexeva (paroxetine mesylate) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Prozac (fluoxetine capsules, USP, fluoxetine oral solution, USP, fluoxetine delayed-release capsules, USP) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Prozac... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Prozac or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Sertraline Hydrochloride Tablets and Oral Concentrate Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 Serotonin Syndrome PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for sertraline hydrochloride... Drug Interactions Serotonergic Drugs Triptans MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression, and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS See highlighted prescribing information for revised text.

Sinequan (doxepin HCl) Capsules and Oral Concentrate Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Sinequan... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sinequan or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Surmontil (trimipramine maleate) Prescribing Information & Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Surmontil... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Surmontil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Symbyax (olanzapine and fluoxetine HCl capsules) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 2 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Symbyax... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Symbyax or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Tekturna (aliskiren) Tablets Prescribing Information	BOXED WARNING Use in Pregnancy WARNINGS Fetal Neonatal Morbidity and Mortality PRECAUTIONS Information for Patients Pregnancy Female patients of childbearing age should be told about the consequences of exposure to drugs that act on the renin-angiotensin system. Discuss other treatment options with female patients planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.	BOXED WARNING: Use in Pregnancy When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus... WARNINGS: Fetal/Neonatal Morbidity and Mortality ...In addition, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin-angiotensin system, has been associated with a potential risk of birth defects in retrospective data. Healthcare professionals that prescribe drugs acting directly on the renin-angiotensin system should counsel women of childbearing potential about the potential risks of these agents during pregnancy...

Wellbutrin (bupropion hydrochloride) Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions" and other important information about using Wellbutrin is available for Wellbutrin... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions" and other important information about using Wellbutrin SR is available for Wellbutrin SR... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin SR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Wellbutrin XL (bupropion hydrochloride extended-release tablets) Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 1 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions" and other important information about Wellbutrin XL is available for Wellbutrin XL... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Wellbutrin XL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior... WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Zyban (bupropion hydrochloride) Sustained-Release Tablets Prescribing Information Medication Guide See MedWatch Safety Alert posted 05/02/2007 for additional information on revised labeling of antidepressant medication products.	BOXED WARNING Suicidality and Antidepressant Drugs WARNINGS Clinical Worsening and Suicide Risk Table 4 PRECAUTIONS Information for Patients ...A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions" and other important information about using Zyban is available for Zyban... MEDICATION GUIDE (updated) Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? What else do I need to know about antidepressant medicines?	BOXED WARNING: Suicidality and Antidepressant Drugs Although Zyban is not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications Wellbutrin, Wellbutrin SR, and Wellbutrin XL. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zyban or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. WARNINGS: Clinical Worsening and Suicide Risk See highlighted prescribing information for revised text.

Back to Summary Page | Back to Top

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Reclast (zoledronic acid) Injection Prescribing Information (in new labeling format) Patient Package Insert	CONTRAINDICATIONS Hypersensitivity to zoledronic acid or any components of Reclast WARNINGS & PRECAUTIONS Hypocalcemia and Mineral Metabolism Renal Impairment Osteonecrosis of the Jaw Pregnancy Musculoskeletal Pain Patients with Asthma ADVERSE REACTIONS Clinical Studies Experience Postmenopausal Osteoporosis Table 1 Renal Impairment Acute Phase Reaction Laboratory Findings Injection Site Reactions Osteonecrosis of the Jaw Atrial Fibrillation Ocular Adverse Events Postmarketing Experience DRUG INTERACTIONS Initial Paragraph Nephrotoxic Drugs USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category D Geriatric Use Hepatic Impairment PATIENT COUNSELING INFORMATION Information for Patients ...Most of these side effects occur within the first 3 days following the dose of Reclast... PATIENT PACKAGE INSERT (updated to include osteoporosis indication) What is the most important information I should know about Reclast? What is Reclast? What should I tell my doctor before getting Reclast? Tell your doctor about all the medicines you take... How will I receive Reclast? What are the possible side effects of Reclast? What is Osteoporosis?	CONTRAINDICATIONS: Hypersensitivity to zoledronic acid or any components of Reclast Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported. WARNINGS & PRECAUTIONS See highlighted prescribing information for revised text.

Risperdal (risperidone) Tablets and Oral Solution Risperdal M-TAB (risperidone) Orally Disintegrating Tablets Prescribing Information (in new labeling format)	CONTRAINDICATIONS WARNINGS & PRECAUTIONS Orthostatic Hypotension Seizures ADVERSE REACTIONS Initial Section Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Schizophrenia Adult Patients with Schizophrenia Table 1 Pediatric Patients with Schizophrenia Table 2 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Bipolar Mania Adult Patients with Bipolar Mania Table 3 Table 4 Pediatric Patients with Bipolar Mania Table 5 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Autistic Disorder Table 6 Other Adverse Reactions Observed During the Premarketing Evaluation of Risperdal Discontinuations Due to Adverse Reactions Schizophrenia - Adults Table 7 Schizophrenia - Pediatrics Bipolar Mania - Adults Table 8 Bipolar Mania - Pediatrics Autistic Disorder - Pediatrics Dose Dependency of Adverse Reactions in Clinical Trials Extrapyramidal Symptoms Other Adverse Reactions Changes in Body Weight Changes in ECG Postmarketing Experience USE IN SPECIFIC POPULATIONS Pediatric Use Weight Gain Somnolence Hyperprolactinemia, Growth, and Sexual Maturation	CONTRAINDICATIONS Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone... WARNINGS & PRECAUTIONS Orthostatic Hypotension ...Syncope was reported in 0.2% (6/2607) of Risperdal-treated patients in Phase 2 and 3 studies in adults with schizophrenia... Seizures During premarketing testing in adult patients with schizophrenia, seizures occurred in 0.3% (9/2607) of Risperdal-treated patients, two in association with hyponatremia. Risperdal should be used cautiously in patients with a history of seizures.

Tegretol (carbamazepine, USP) Chewable Tablets and Suspension Tegretol-XR (carbamazepine extended-release tablets) Prescribing Information	CONTRAINDICATIONS WARNINGS Initial Section Usage in Pregnancy PRECAUTIONS General ...Cardiac conduction disturbance, including second and third degree AV heart block... ...AV heart block, including second and third degree block, have been reported following, Tegretol treatment. This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances. Information for Patients Tegretol may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or non-prescription medications or herbal products. Caution should be exercised if alcohol is taken in combination with Tegretol therapy, due to a possible additive sedative effect. Drug Interactions Agents that May Affect Tegretol Plasma Levels Effect of Tegretol on Plasma Levels on Concomitant Agents	CONTRAINDICATIONS ...Co-administration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Co-administration of carbamazepine with nefazodone is contraindicated. WARNINGS: Initial Section ...The use of Tegretol should be avoided in patients with a history of hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). Acute attacks have been reported in such patients receiving Tegretol therapy. Carbamazepine administration has also been demonstrated to increase porphyrin precursors in rodents, a presumed mechanism for the induction of acute attacks of porphyria. As with all antiepileptic drugs, Tegretol should be withdrawn gradually to minimize the potential of increased seizure frequency. WARNINGS: Usage in Pregnancy ...There have also been reports that associate carbamazepine with developmental disorders and congenital anomalies (e.g., craniofacial defects, cardiovascular malformations and anomalies involving various body systems). Developmental delays based on neurobehavioral assessments have been reported...

Back to Summary Page | Back to Top

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Albenza (albendazole) Tablets Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Laboratory Tests White Blood Cell Count Liver Function ADVERSE REACTIONS The following adverse events were observed at an incidence of < 1%: Blood and Lymphatic System Disorders Immune System Disorders Postmarketing Adverse Reactions Blood and Lymphatic System Disorders Hepatobiliary Disorders Skin and Subcutaneous Tissue Disorders Renal and Urinary Disorders	WARNINGS ...Albendazole has been shown to cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with and without underlying hepatic dysfunction... ...Patients with liver disease, including hepatic echinococcosis, appear to be more at risk for bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia attributable to albendazole and warrant closer monitoring of blood counts. Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur....

Ceftin Tablets (cefuroxime axetil tablets) Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension) Prescribing Information	WARNINGS PRECAUTIONS General Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ceftin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

NegGram Suspension (nalidixic acid, USP) Oral Suspension Prescribing Information	WARNINGS PRECAUTIONS Information for Patients ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including NegGram, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.