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

The agency will study the drug to determine whether there is truly a causal link. The FDA is also 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 Pneumonia