FDA List Is Based On Reports Made To Adverse Event Reporting System (AERS) Between July And September 2008
(Posted by Tom Lamb at DrugInjuryWatch.com)
On February 4, 2008 the FDA posted on its web site a new list of prescription drugs it will be studying for potential safety problems. The FDA's list, "Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008", is presented in the form of a table with the following fields:
- Product Name: Active Ingredient (Trade) or Product Class
- Potential Signal of Serious Risk/New Safety Information
- Additional Information Available as of January 30, 2009
The preface to this FDA list has some very important qualifying language:
The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.
A February 4, 2008 Reuters article, "US FDA lists drugs under review for safety issues", provided this overview of the FDA's current list of drugs with so-called "safety signals":
The products under review included schizophrenia drug Abilify, one of Bristol-Myers Squibb Co's (BMY.N) fastest- growing products. Post-marketing data raised concern about possible liver toxicity and other issues, the FDA said.
The FDA also said it was reviewing Roche Holding AG's (ROG.VX) diet drug, Xenical, for the risk of rectal bleeding to see whether any agency action was needed.
In addition, the agency said evaluating the risk of birth defects with widely-used SSRI and SNRI antidepressants, which already carry strong warnings about suicidal behavior.
Well-known antidepressants include Eli Lilly and Co's (LLY.N) Prozac, Pfizer Inc's (PFE.N) Zoloft, GlaxoSmithKline Plc's (GSK.L)(GSK.N) Paxil and Forest Laboratories Inc's (FRX.N) Lexapro and Celexa.
Insofar that the newly listed drugs are under an ongoing safety review by the FDA, anyone with information about a patient experiencing a possible serious side effect that may be associated with any of these drugs should submit a MedWatch report to the FDA for the agency's consideration.