Latest FDA Watch List: 2 Drugs, All Acetaminophen Products

May 06, 2013

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.

All products containing acetaminophen appear on the latest watch list because of reports of severe skin reactions. Dermatologic disorders are known adverse reactions associated with these analgesics.

Fingolimod (Gilenya, Novartis Pharmaceuticals), indicated to reduce relapses and delay disability progression in patients with MS, was added to the list after FAERS received reports of hemophagocytic syndrome, a rare and potentially fatal disease of normal but overactive histiocytes and lymphocytes.

The FDA also added anagrelide (Agrylin, Shire), approved for thrombocythemia secondary to myeloproliferative disorders, because of reports of torsades de pointes, a rare and life-threatening heart arrhythmia.

Potential Signals of Serious Risks/New Safety Information Identified by FAERS, October to December 2012

Product Name: Active Ingredient (Trade) or Product Class Potential Signal of a Serious Risk/New Safety Information Additional Information
Acetaminophen-containing products Severe skin reactions FDA is continuing to evaluate this issue to determine the need for any regulatory action
Anagrelide HCl (Agrylin, Shire) Torsades de pointes FDA is continuing to evaluate this issue to determine the need for any regulatory action
Fingolimod (Gilenya, Novartis Pharmaceuticals) Hemophagocytic syndrome FDA is continuing to evaluate this issue to determine the need for any regulatory action

More information on FAERS and its quarterly watch list is available on the FDA Web site.


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