Recently, data from several clinical studies has raised concern regarding potential increased health risks associated with the use of prescription COX-2 selective, non-steroidal anti-inflammatory drugs (NSAID), such as Celebrex, Bextra, Vioxx and Aleve.
In late September, 2004, Merck & Co., Inc. announced a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on rofecoxib. Rofecoxib is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID).
Patients who are taking these drugs and have concerns about their risks for complications should consult with their physician.
According to a statement issued by the U.S. Food and Drug Administration, FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed.
An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues. In the meantime, the FDA has issued a public health advisory regarding these medicines.
Additional information is available from the following website:
www.fda.gov/bbs/topics/A...ANS01336.html
www.rheumatology.org/press/2...news.asp
www.rheumatology.org/publica...ioxx.asp
www.fda.gov/medwatch/SAF...y04.htm#vioxx
www.fda.gov/cder/drug/in...PHA_vioxx.htm
www.fda.gov/bbs/topics/n...NEW01122.html
www.fda.gov/cder/drug/in...x/vioxxQA.htm
In late September, 2004, Merck & Co., Inc. announced a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on rofecoxib. Rofecoxib is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID).
Patients who are taking these drugs and have concerns about their risks for complications should consult with their physician.
According to a statement issued by the U.S. Food and Drug Administration, FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed.
An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues. In the meantime, the FDA has issued a public health advisory regarding these medicines.
Additional information is available from the following website:
www.fda.gov/bbs/topics/A...ANS01336.html
www.rheumatology.org/press/2...news.asp
www.rheumatology.org/publica...ioxx.asp
www.fda.gov/medwatch/SAF...y04.htm#vioxx
www.fda.gov/cder/drug/in...PHA_vioxx.htm
www.fda.gov/bbs/topics/n...NEW01122.html
www.fda.gov/cder/drug/in...x/vioxxQA.htm
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