Healthcare Professional Sheets

Information for Healthcare Professionals: This information from FDA is for doctors, pharmacists, nurses, and other healthcare professionals. It contains an "alert" (a summary of the new safety information), detailed information about the safety issue, factors to consider when making treatment decisions, information for healthcare professionals to discuss with patients about their roles in reducing the risks from the drug, and a summary of the facts or data that serve as the basis for the information in the page.

 

2009

2008

2007

2006

2005

 

2009

Peramivir IV Renal Dosing Recommendations (11/19/2009)

Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC) (11/17/2009)

Chondrolysis Reported with Continuously Infused Local Anesthetics (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine) (11/13/2009)

Potential Contamination of Products Manufactured by Genzyme Corporation, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen (11/13/2009)

Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta) (11/2/2009)

Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA (10/23/2009)

Tamiflu: Authorization of Use of Expired Tamiflu for Oral Suspension (10/2/2009)

Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet) (9/25/2009)

Intravenous Promethazine and Severe Tissue Injury, Including Gangrene (9/16/2009)

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) (8/4/2009)

OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc) (8/3/2009)

Colchicine (marketed as Colcrys) (7/30/2009)

Immunosuppressant Drugs: Required Labeling Changes (7/14/2009)

Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) (7/1/2009)

Cefepime (marketed as Maxipime) (6/17/2009)

Sirolimus (marketed as Rapamune) (6/11/2009)

Propylthiouracil-Induced Liver Failure (6/4/2009)

Ceftriaxone (marketed at Rocephin) (4/21/2009)

Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens (3/19/2009)

 

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2008

Suicidality and Antiepileptic Drugs (12/16/2008)

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) (12/11/2008)

Exenatide (marketed as Byetta) (8/2008)

Abacavir (marketed as Ziagen) and Abacavir-Containing Medications (7/24/2008)

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) (7/17/2008)

Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR), gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin), moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin (marketed as Floxin and generic ofloxacin)] (7/8/2008)

Conventional Antipsychotics (6/16/2008)

Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) (5/16/2008)
Darunavir Ethalolate (marketed as Prezista) (3/21/2008)

Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension) (3/11/2008)

Interferon gamma-1b (marketed as Actimmune) (3/9/2007)

Varenicline (marketed as Chantix) (2/1/2008)

Zonisamide (marketed as Zonegran) (2/23/2008)

Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) (1/7/2008)

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2007

Fentanyl Transdermal System (marketed as Duragesic and generics) (12/21/2007)

Dangerous or Even Fatal Skin Reactions - Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics) (12/12/2007)

Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) (12/4/2007)

Erythropoiesis Stimulating Agents (ESA) [Aranesp (darbepoetin), Epogen (epoetin alfa), and Procrit (epoetin alfa)] (11/8/2007)

Sildenafil (marketed as Viagra and Revatio) Vardenafil (marketed as Levitra) Tadalafil (marketed as Cialis) (11/2007)

Fentanyl Buccal Tablets (marketed as Fentora) (9/2007)

Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate) (9/2007)

Use of Codeine Products in Nursing Mothers (8/17/2007)

Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact) (8/2007)

Propofol (marketed as Diprivan and as generic products) (6/2007)

Linezolid (marketed as Zyvox) (3/16/2007)

Omalizumab (marketed as Xolair) (2/2007)

 

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2006

Rituximab (marketed as Rituxan) (12/2006)

Concomitant Use of Ibuprofen and Aspirin (9/2006)

Lamotrigine (marketed as Lamictal) (9/2006)

Citalopram (marketed as Celexa) (7/2006)

Duloxetine (marketed as Cymbalta) - Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) and 5-Hydroxytryptamine Receptor Agonists (Triptans)) (7/2006)

Escitalopram (marketed as Lexapro) - Selective Serotonin Reuptake Inhibitors (SSRIs) (7/2006)

Fluoxetine (marketed as Prozac) (7/2006)

Fluvoxamine - Selective Serotonin Reuptake Inhibitors (SSRIs) (7/2006)

Olanzapine/fluoxetine (marketed as Symbyax) (7/2006)

Paroxetine (marketed as Paxil) (7/2006)

Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), 5-Hydroxytryptamine Receptor Agonists (Triptans) (7/2006)

Sertraline (marketed as Zoloft) (7/2006)

Venlafaxine (marketed as Effexor) - Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), 5-Hydroxytryptamine Receptor Agonists (Triptans) (7/2006)

Colistimethate (marketed as Coly-Mycin M and generic products) (6/28/2007)

Angiotensin-Converting Enzyme Inhibitor (ACE Inhibitor) Drugs and Pregnancy (6/2006)

Promethazine (marketed as Phenergan and generic products) (4/2006)

Diazepam Rectal Gel (marketed as Diastat AcuDial) (3/2006)

Gatifloxacin (marketed as Tequin) (3/2006)

 

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2005

Clarithromycin (marketed as Biaxin) (12/2005)

Alemtuzumab (marketed as Campath) (11/2005)

Isotretinoin (marked as Accutane) (11/2005)

Mifepristone (marketed as Mifeprex) (11/2005)

Pemoline Tablets and Chewable Tablets (marketed as Cylert) (10/2005)

Atomoxetine (marketed as Strattera) (9/2005)

Adderall and Adderall XR (amphetamine) (8/2005)

Gefitinib (marketed as Iressa) (6/2005)

Amiodarone (marketed as Cordarone) (5/2005)

Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)* (4/7/2005)

Valdecoxib (marketed as Bextra) (4/7/2005)

Galantamine hydrobromide (marketed as Razadyne, formerly Reminyl) (3/2005)

Rosuvastatin Calcium (marketed as Crestor) (3/2005)

Tiagabine hydrochloride (marketed as Gabitril) (2/18/2005)