Pill Identifier App

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

ROCKVILLE, Md., June 4, 2009--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 May 7, 2009)

Apomorphine (Apokyn) Psychiatric events FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Choriogonadotropin alfa (Ovidrel) Anaphylactic reactions FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Clomiphene citrate (Clomid) Visual disorders FDA is evaluating this issue to determine if the labeling, which includes visual disorders in the Warnings and Adverse Reactions sections, is adequate.
Clozapine orally disintegrating tablet (FazaClo) Deaths 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.
Darifenacin (Enablex) and Solifenacin (Vesicare) Angioedema and other allergic reactions FDA is continuing to evaluate these issues to determine the need for any regulatory action.
Drospirenone/ethinyl estradiol (Yasmin) Pancreatitis FDA is evaluating this issue to determine if the labeling, which includes pancreatitis, is adequate.
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
Fibrin sealant, human (Evicel) Air embolism FDA is evaluating this issue to determine if labeling is adequate.
Hydrochlorothiazide in combination products Skin reactions FDA is evaluating this issue to determine if labeling is adequate for the various hydrochlorothiazide-containing combination products.
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 labeling will be updated to include this event.

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.

FDA is continuing to evaluate this issue to determine the need for any further regulatory action.

Orlistat (Xenical, Alli) Hepatotoxicity FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Polyethylene glycol oral laxative (various trade names) Neuropsychiatric events FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Raltegravir (Isentress) Psychiatric events The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events.
Raltegravir (Isentress) labeling
Selegiline (Emsam) Hypertension FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Sumatriptan/naproxen (Treximet) Myocardial infarction FDA 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.
Tolterodine tartrate (Detrol) Stevens-Johnson syndrome FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Varenicline (Chantix) Angioedema, serious skin reactions, visual impairment, accidental injury FDA is continuing to evaluate these issues to determine the need for any regulatory action.
    

Posted: June 2009


View comments

Hide
(web5)