FDA is posting this list of drugs with issues that perhaps if you are taking you would want to contact your
doctor about. This is
not a recall list. This listing comes out of the new Food and Drug Cosmetic Act of 2007,
Public Law 110-85, signed in September 2007 and comes from the Adverse Event Reporting System:
http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htmThe table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January - March 2008 in the AERS database. 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.http://www.guardian.co.uk:80/business/feedarticle/7777649But agency officials voiced concern the preliminary information could cause patients to stop taking important drugs. "Don't stop taking your medicine," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.While it looks like some of the companies making these drugs are going to be adversely impacted, ultimately it may be a good thing if the
manufacturers learn that positive and negative drug testing results should be presented to the FDA and the public, which I believe many manufacturers are not presently doing. Perhaps the negative financial impact to the drug companies could be avoided, too, in the future.