FDA Targets 8 drugs that have potential adverses health effects

FDA Adds 8 Drugs to Watch List



The US Food and Drug Administration (FDA) has added 8 drugs to its list of products to monitor because of possible signs of serious risks or new safety information. The drugs treat conditions that include cancer, epilepsy, hypertension, and malaria.

The agency spotted yellow flags for the 8 drugs in the FDA Adverse Event Reporting System (FAERS) database during April, May, and June 2012.

Making the FDA's watch list does not mean that the agency has concluded that the drug actually poses the health risk reported through FAERS, formerly known as AERS. Rather, the agency will study the drug to determine whether there is truly a causal link. If it establishes a link, the FDA then would consider a regulatory response such as gathering more data to better characterize the risk, revising the drug's label, or requiring a risk-evaluation and mitigation strategy.

The FDA also is not suggesting that clinicians should stop prescribing watch-list drugs, or that patients should stop taking them, according to an agency press release.

Potential Signals of Serious Risks/New Safety Information Identified by FAERS, April to June 2012

Product Name: Active Ingredient (Trade) or Product Class

Potential Signal of a Serious Risk/New Safety Information

Additional Information (as of August 1, 2012)*

Cetirizine HCl (Zyrtec, McNeil)

Oculogyric crisis


Codeine sulfate

Respiratory depression or arrest resulting in death in children taking codeine who are CYP2D6 ultra-rapid metabolizers

FDA Drug Safety Communication

Docetaxel (Taxotere, sanofi-aventis)

Drug interaction with dronedarone HCl resulting in death

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

Fluoroquinolone products

Retinal detachment


Levetiracetam (Keppra, UCB)

Potential for drug abuse, misuse, or dependence


Mefloquine HCl (Lariam, Roche)

Vestibular disorder


Olmesartan medoxomil (Benicar, Daiichi Sankyo)

Malabsorption resulting in severe diarrhea and weight loss

FDA is continuing to evaluate this issue to determine if the current labeling, which contains information about diarrhea, is adequate.

Proton pump inhibitors



* Unless otherwise noted, the FDA is continuing to evaluate these issues to determine the need for any regulatory action.

More information on FAERS and its quarterly watch list is available on the FDA Web site.

Call Emergency Medicine Expert 510-549-1041
Copyright © 2020 - toxicologyexpert.net