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Science FDA announces first-time list of "potential" problem drugs
Science FDA announces first-time list of "potential" problem drugs | FDA announces first-time list of "potential" problem drugs |
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| by William Atkins | |
| Monday, 08 September 2008 | |
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Science DiscussionsOn Friday, September 5, 2008, the U.S. Food and Drug Administration (FDA) began publicly listing prescription drugs that are under investigation for potential safety problems. The action by the FDA is to help better inform doctors and patients on the possible seriousness with using these drugs. The FDA website states, “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.” It adds, “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.” The website concludes, “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.” The FDA list of prescription drugs with potential safety issues is found on page two. |
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