The US Food and Drug Administration (FDA) has added several 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 these 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 |
|
|
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 |
Pneumonia |
|
* 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.
