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FDA to bring about changes in Marketed Non-Steroidal Anti-Inflammatory Drugs

by Medindia Content Team on  April 9, 2005 at 3:19 PM General Health News   - G J E 4
FDA to bring about changes in Marketed Non-Steroidal Anti-Inflammatory Drugs
American drug market watchdog Food and Drug Administration had announced a series of changes to be followed for the drugs in the class of non-steroidal anti-inflammatory drugs that are sold with or without prescription over the counter. These changes include the withdrawal of the drug Bextra (valdecoxib) from Pfizer, Inc.
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Pfizer, Inc was asked to withdraw the drug Bextra as FDA had reports that the overall risk associated with the drug overshadows the benefits. FDA had also asked the drug company to change the label of the drug Celebrex (celecoxib) to include in a box some specific warnings about risk of cardiovascular problems and gastrointestinal bleeding because of the usage of the drug.

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Manufacturer of other prescription and nonprescription non-steroidal anti-inflammatory drugs (NSAID) were also asked to provide a similar label highlighting the cardiovascular and gastrointestinal risks associated with the use of the said drugs. The makers of over the counter NSAIDs were also asked to provide information about skin reactions and any other information that will help the consumer to use the drug safely.

In addition to the instructions to the drug manufacturers, FDA had also updated the patient and healthcare practitioner fact sheets.

Reference: www.fda.gov/cder , non-steroidal anti-inflammatory drugs, NSAID, Celebrex, celecoxib, gastrointestinal risks, cardiovascular risks, FDA
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