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View Full Version : Latest FDA Watch List: 2 Drugs, All Acetaminophen Products



Janis.Y.Chen
Tue 7th May '13, 2:12am
The US Food and Drug Administration (FDA) has added a drug for multiple sclerosis (MS), another drug for a blood disorder, and all acetaminophen-containing products to its quarterly list of products to monitor because of possible signals of serious risks or new safety information.

The agency received reports of possible adverse events for these products in the FDA Adverse Event Reporting System (FAERS) database during the fourth quarter of 2012. Making the watch list does not mean that the FDA has determined that the drug poses the specific health risk reported through FAERS. What it does mean is that the FDA will investigate whether there is a causal link. If the answer is yes, the agency would consider a regulatory move such as gathering more data to better describe the risk, revising the drug's label, or requiring a risk evaluation and mitigation strategy.

By putting a drug on the watch list, the FDA is not suggesting that clinicians should stop prescribing it or that patients should stop taking it, the agency says.

For the full information please visit Medscape at http://www.medscape.com/viewarticle/803648