Bextra® Warning
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Recent Bextra® warning statements have prompted concerns about the cardiovascular safety of taking this COX-2 selective non-steroidal anti inflammatory drug (NSAID). Bextra® is a prescription medication that was approved by the FDA in November 2001. Bextra® is used to treat patients who suffer from the severe pain associated with osteoarthritis, rheumatoid arthritis and primary dysmenorrhea.
Bextra® warning statements regarding cardiovascular safety follow the recent Vioxx recall that occurred on September 30, 2004. Vioxx is also a COX-2 selective NSAID that was used to treat pain. The recall was prompted by research findings indicating that patients taking Vioxx for eighteen months double their risk of suffering from a serious heart attack or stroke. Because this drug is so similar to Bextra® in its actions on the body, Bextra® warning concerns have been raised regarding the safety of Bextra® and all other COX-2 selective NSAIDs.
Pfizer, the manufacturers of Bextra®, claim that no substantiated evidence of Bextra® cardiovascular side effects has been discovered in clinical trials. Bextra® warning statements were made at an American Heart Association meeting in early November 2004, indicating that studies showed an increase of cardiovascular side effects for Bextra® users who underwent cardiac bypass surgery.
This Bextra® warning was then relayed in a New York Times article stating that Bextra® may have adverse effects on cardiovascular health. Pfizer retorted by stating that none of these findings are substantiated and that the company intends on initiating long term studies on the long term effects of Bextra® on cardiovascular health. The FDA also plans on conducting studies on the effects of all COX-2 selective on cardiovascular health.
Bextra® warning statements have already be included in Bextra® labeling information. Bextra® causes rare but serious skin diseases in some patients who take this medication. Bextra® warning statements indicate that Bextra® side effects may include Stevens-Johnson syndrome, a rare skin condition characterized by a severe inflammatory eruption of the skin and mucous membranes. Toxic epidermal necrolysis is also a potential side effect of taking Bextra®. This skin condition causes large portions of the skin to become red and peel in the manner of a second degree burn. Bextra® warning statements also caution that Bextra® can cause severe allergic reactions in some patients, including anaphylactic shock.
These Bextra® warning statements have been included in packaging since 2002. The FDA is currently considering adding a Bextra® warning black box to all Bextra® labeling, which is the FDA's strongest alert to inform consumers of drug dangers. The legitimacy of Bextra® warning statements regarding cardiovascular health is still inconclusive. If you are concerned about Bextra® warning information, you may wish to speak with your doctor. If you have suffered adverse health problems as a result of taking Bextra®, you may wish to speak with a lawyer who can advise you of your rights and options in a civil case to recover damages.
Please contact a Bextra® Lawyer if you would like more information on the Bextra® warning and your legal rights and options.
