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FDA Identifies 19 Potentially Dangerous Drugs on the Market

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As we know, drugs that are shown to be “safe” for public consumption through clinical trials sometimes prove dangerous when actually consumed by the public on a day-to-day basis. Expecting this, the FDA gathers adverse event reports on every approved drug on the market. When it spots a pattern of adverse events associated with a particular drug, it puts this drug under intense scrutiny. If the drug proves, after extensive testing, to be dangerous, the FDA may implement new regulations such as a change in labeling, use restrictions, or black box warnings. Occasionally, as was the case with Merck’s Vioxx, safety concerns will compel the FDA to remove the drug completely from the market.

Below is the most recent list of drugs currently under close scrutiny by the FDA.

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 September 24, 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 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)

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

pdated
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 (PDF – 285KB)

-FDA website

If you are taking any of the above drugs and are concerned about its potential adverse effects, please contact your health care provider right away.