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 (http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm) |
| 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 |
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