The drugs, 20 in total, have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS), which contains millions of reports of adverse events submitted to the FDA by drug manufacturers, health care professionals and patients.
The list includes a wide array of drugs, from Eli Lilly & Co.'s antidepressant Cymbalta to Purdue Pharma LP's painkiller Oxycontin. It also addresses a range of potential adverse reactions including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated.
The list consists of adverse events reported between Jan. 1 and March 31, 2008 and the federal agency has not given any deadline as to when the reports will be out. However, nobody should stop taking a drug just because it's on the list, the FDA said on its website.
Under provisions of the FDA Amendments Act, signed into law Sept. 27, 2007, the FDA is required to inform the public each quarter of new safety information or potential signals of serious risk. Each quarter, a new report will be posted to FDA's website listing additional drugs that would be evaluated by FDA for its safety concerns through AERS.
