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U.S. Department of Health and Human Services

Drugs

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Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period October - December 2008 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008

Product Name: Active Ingredient (Trade)
or Product Class
Potential Signal of Serious Risk/New Safety Information

Additional Information

(as of March 1, 2014)

Apomorphine (Apokyn)Psychiatric events

The Warnings and Precautions section of the labeling for Apokyn was updated September 2010, to include psychiatric events.

 
Clomiphene citrate (Clomid)Visual disorders

The Warnings and Precautions and Adverse Reactions sections of the labeling for Clomid were updated October 2012, to include visual disorders.

Clomiphene citrate (Clomid) Labeling approved October 22, 2012 (PDF - 144KB

Clozapine orally disintegrating tablet (FazaClo)Deaths

FDA has determined that no action is necessary at this time based on available information.

This issue relates to a finding, based on AERS reports, that the proportion of death events versus all events is higher for FazaClo than for other clozapine products. The reported events in the death cases are similar for FazaClo and other clozapine products. FDA is continuing to evaluate this issue.
Drospirenone/ethinyl estradiol (Yasmin)Pancreatitis

The Warnings and Precautions section of the labeling for Yasmin was updated February 2012, to include pancreatitis.

Drospirenone/ethinyl estradiol (Yasmin) Labeling approved February 13, 2012 (PDF - 594KB)

Efavirenz (Sustiva)Birth defects involving the eye and face

This issue stemmed from a case of anophthalmia in AERS that was originally reported to the Antiretroviral Pregnancy Registry (APR). The labeling was updated in March 2009 to include a description of this case.

Efavirenz (Sustiva) Labeling approved September 23, 2009 (PDF - 326KB)

In March 2010, FDA issued Safety Labeling changes about Reproductive Risk Potential to the Warnings and Precautions section of the Labeling for Sustiva.

Efavirenz (Sustiva) Labeling approved March 31, 2010 (PDF - 385KB)

Fibrin sealant products, human (Evicel, Tisseel, Artiss)
 
Air embolism

FDA issued a Safety Alert on July 9, 2010.

The Warnings and Precautions section of the labeling for fibrin sealant products, including Evicel, was revised to emphasize recommended spraying pressure and proximity to tissue in November 2009.

Dear Healthcare Professional letters for fibrin sealant products were issued in September 2009 and October 2009.

Refer to the April 2010 Drug Safety Labeling Changes summary page, listing products with "Fibrin Sealant" on the MedWatch site.

Fibrin sealant (Tisseel) Labeling (PDF - 146KB)

Fibrin sealant, human (Evicel) Labeling (PDF - 197KB)

Fibrin sealant, human (Artiss) Labeling (PDF - 230KB)

Human chorionic gonadotropin products
Choriogonadotropin alfa (Ovidrel)
Chorionic gonadotropin
(Pregnyl)
Anaphylactic reactions

The Warnings and Precautions, and Adverse Reactions sections of the labeling for Ovidrel were updated June 2010, to include anaphylactic reactions.

Choriogonadotropin alfa (Ovidrel) Labeling approved June 2, 2010 (PDF - 155KB)

The Warnings and Precautions, and Adverse Reactions sections of the labeling for Pregnyl were updated April 2011, to include anaphylactic reactions.

Chorionic gonadotropin (Pregnyl) Labeling approved April 15, 2011 (PDF - 26.7KB)

Hydrochlorothiazide in combination productsSkin reaction

No further regulatory action is planned at this time.

The Adverse Reactions section of the labeling for Ziac was updated November 2009 to address this issue.

Bisoprolol fumarate and hydrochlorothiazide (Ziac) Labeling approved November 6, 2009 (PDF - 184KB)

The Adverse Reactions section of the labeling for Lotensin HCT was updated November 2009 to address this issue.

Benazepril hydrochloride and hydrochlorothiazide (Lotensin HCT) Labeling approved November 10, 2009 (PDF - 138KB)

The Adverse Reactions section of the labeling for Hydrochlorothiazide/Triamterene (Dyazide) was updated February 2010 to address this issue.

Hydrochlorothiazide and triamterene (Dyazide) Labeling approved February 23, 2010 (PDF - 103KB)

The Adverse Reactions section of the labeling for Propanolol/Hydrochlorothiazide (Inderide) was updated March 2010 to address this issue.

Propranolol hydrochloride and hydrochlorothiazide (Inderide) Labeling approved March 4, 2010 (PDF - 101KB) 

Imiquimod cream (Aldara)Dysuria due to severe local reactions during use in the genital area

This issue was identified during a review of imiquimod adverse events as required by the Best Pharmaceuticals for Children Act and was presented at the November 18, 2008 Pediatric Advisory Committee meeting: One Year Post-Exclusivity Adverse Event Review: Imiquimod Pediatric Advisory Committee Meeting November 18, 2008 (PDF - 83 KB)  (refer to Slide 24).

 

The Adverse Reactions section of the labeling for Aldara was updated October 2010, to include dysuria.
 
Modafinil (Provigil) and Armodafinil (Nuvigil)Serious skin reactions

This issue was originally identified from AERS reports and added to labeling in 2007. An FDA Drug Safety Newsletter article featured this issue in Fall 2007: Modafinil (marketed as Provigil): Serious Skin Reactions.

Modafinil (Provigil) Labeling approved October 21, 2010 (PDF - 239KB)

The Warnings and Precautions and Adverse Reactions sections of the labeling for Nuvigil were updated October 2010, to include serious skin reactions.

Armodafinil (Nuvigil) Labeling approved October 21, 2010 (PDF - 523KB)

Muscarinic Receptor Antagonists
Angioedema and other allergic reactions

The Warnings and Precautions section of the labeling for Vesicare was updated July 2010, to include these issues.

 
 
The Warnings and Precautions section of the labeling for Enablex was updated October 2010, to include these issues.
 
 
The Warnings and Precautions section of the labeling for Gelnique was updated January 2011, to include these issues.
 
 
The Warnings and Precautions section of the labeling for Oxytrol was updated January 2011, to include these issues.
 
 
The Warnings and Precautions section of the labeling for Sanctura and Sanctura XL was updated January 2011, to include these issues.
 
 
The Warnings and Precautions section of the labeling for Toviaz was updated February 2011, to include these issues.
 
 

FDA is continuing to evaluate these issues to determine whether current labeling is adequate.

Orlistat (Xenical, Alli)Hepatotoxicity

The Warnings and Precautions, Adverse Reactions, and Patient Information sections of the labeling for Xenical were updated January 2012, to include additional information about hepatotoxicity.

Orlistat (Xenical) Labeling approved January 20, 2012 (PDF - 408KB)

FDA issued an Early Communication about an Ongoing Safety Review on this issue in August 2009.


Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)

FDA issued a Completed Safety Review Communication for Alli/Xenical in May 2010.

This issue was added to the Precautions and Adverse Reactions sections of the labeling for Xenical in May 2010.

Orlistat (Xenical) Labeling approved May 25, 2010 (PDF - 420KB)

 

This issue was added to the Drug Facts section of the labeling for Alli in February 2011.

Polyethylene glycol oral laxative (various trade names)Neuropsychiatric events

FDA has determined that no regulatory action is needed at this time.

Raltegravir (Isentress)Psychiatric events

The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events.


Raltegravir (Isentress) labeling approved November 4, 2009 (PDF - 362KB)

Selegiline (Emsam)Hypertension

Updated

FDA decided that no action is necessary at this time based on available information.

Sumatriptan/naproxen (Treximet)Myocardial infarctionFDA evaluated case reports in AERS and determined that the current labeling, which includes a Boxed Warning addressing myocardial infarction, is adequate.
Testosterone gel (Androgel, Testim)Adverse events from accidental exposure

May 2009 FDA News Release, Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide, describes the addition of a Boxed Warning to the labeling addressing adverse events in children and women due to accidental exposure to testosterone gel.

Testosterone gel (AndroGel) Labeling approved September 18, 2009 (PDF - 385KB)

Testosterone gel (Testim) Labeling approved September 18, 2009 (PDF - 259KB)

Tolterodine tartrate (Detrol)Stevens-Johnson syndrome

FDA has determined that the current Tolterodine tartrate labeling is adequate and that no further regulatory action is needed at this time.

Varenicline (Chantix)Angioedema, serious skin reactions, visual impairment, accidental injury

In July 2009, FDA approved revised labeling (changes to Precautions and Adverse Reactions sections and changes to the Medication Guide) to include angioedema, serious skin reactions, and accidental injury.


Varenicline (Chantix) Labeling approved July 1, 2009 (PDF - 285KB)