Regulating Bextra Tips
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How has Pfizer reacted to claims that Bextra is unsafe?
Pfizer, the manufacturer of Bextra, claims that no substantive evidence of Bextra cardiovascular side effects was discovered in clinical trials. The earliest Bextra warning statements were made at an American Heart Association meeting in early November 2004. They cited studies showing an increase of cardiovascular side effects for Bextra users who underwent cardiac bypass surgery. Later, a New York Times article appeared 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.
The Bextra debate
While Pfizer has promised to carry out a long-term investigation of the side effects of Bextra, it is far too late to be of comfort to the thousands of innocent users already suffering from painful and potentially fatal consequences. Drug makers have a special responsibility to provide important health information to consumers, including warnings about potential harmful risks, before the drug begins to cause permanent harm. Your health should never be jeopardized by of a lack of knowledge about the effects of your prescription medications.
The Bextra debate
While Pfizer has promised to carry out a long-term investigation of the side effects of Bextra, it is far too late to be of comfort to the thousands of innocent users already suffering from painful and potentially fatal consequences. Drug makers have a special responsibility to provide important health information to consumers, including warnings about potential harmful risks, before the drug begins to cause permanent harm.
Recall of Bextra
After careful studies of the risk of not only heart attack and strokes, but also the frequency of potentially fatal allergic skin reactions, the FDA re-evaluated Bextra and on April 7, 2005, they asked Pfizer to remove Bextra from American and European markets. Widespread prescriptions of Bextra had already caused significant damage, and may victims of the drug's side effects continue to suffer from the terrible consequences.
Bextra and the FDA
In early 2005, Pfizer stopped selling Bextra over concerns about Bextra's link to rare, life-threatening skin reactions. These concerns are not new. The FDA required Pfizer to add a black-box warning about them to Bextra's label in early December. At the same time, the FDA also required that Pfizer add information to Bextra's label to highlight new data about heart-attack and stroke risk. A recently completed study had found an increased cardiovascular risk in patients who had received Bextra after undergoing bypass surgery, compared with those who had received a placebo.
Bextra and the FDA
Bextra was approved by the FDA in 2001 to treat the severe pain associated with osteoarthritis, rheumatoid arthritis, menstrual cramps, and a number of other chronic pain conditions. Originally these drugs were designed to provide effective pain relief without the harmful gastrointestinal side effects associated with original NSAIDs like naproxen and ibuprofen. It was pulled from the market in 2005.
Bextra and the FDA
In view of the recent concerns over dangerous side effects of COX-2 selective drugs like Bextra, the FDA has mandated further studies. In addition, the FDA urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), or by fax (1-800-FDA-0178).
Bextra and the FDA
In February of 2005 an FDA advisory panel recommended the FDA allow Bextra and Celebrex to remain on the market, though most experts agreed the drugs presented potentially fatal heart attack and stroke risks. However, the FDA elected to pull Bextra from the market. This was a break from usual practice, as the FDA usually goes along with advisory panel recommendations.
