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FDA releases first quarterly drug safety report
Several oncology drugs are identified as having potential serious adverse events.
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On Friday the FDA posted its first quarterly report of drugs currently under evaluation for potential safety issues.
The drugs included on the list were identified based on a review of reports in the FDA’s Adverse Event Reporting System, according to a press release. The following are some of the drugs included on the list and the potential signals of serious risks associated with the drugs:
- fluorouracil cream (Carac, Sanofi-Aventis) and ketoconazole cream (Kuric, JSJ Pharmaceuticals) for adverse events due to name confusion;
- heparin for risk of anaphylactic-type reactions;
- lapatanib (Tykerb, GlaxoSmithKline) for hepatotoxicity risk;
- lenalidomide (Revlimid, Celgene) for risk of Stevens Johnson Syndrome;
- natalizumab (Tysabri, Elan Pharmaceuticals Inc.) for risk of skin melanomas;
- oxycodone hydrochloride controlled-release (Oxycontin, Purdue Pharma L.P.) for drug misuse, abuse and overdose;
- octreotide acetate depot (Sandostatin LAR, Novartis Oncology) for ileus;
- ivermectin (Stromectol, Merck) and warfarin for drug interaction; and
- tumor necrosis factor blockers for a risk for cancers in children and young adults.
The FDA cautioned physicians and patients that, although a drug appears on this list, the FDA has not necessarily concluded that the drug carries the potential risk listed. It also does not mean that the FDA has identified a causal relationship between the two.
As part of the FDA Amendments Act, signed into law on Sept. 27, 2007, the FDA will report new safety information or potential serious advserse events to the public every three months.