FDA Adds New Potentially Hazardous Drugs to its Watch List
Published: Tuesday, 18 December 2012 23:54
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.
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