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Bextra Drug Information for COX-II Users.

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Bextra Lawsuit Information: Important Drug Information

• On April 7, 2005, the FDA asked Pfizer, Inc. to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug was unfavorable.
• Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency.
• In December 2004, the European Medicines Agency (EMEA) and its Scientific Committee for human medicines were made aware of new safety information on cardiovascular and serious skin adverse events in relation to the use of valdecoxib and parecoxib sodium:
  • Two clinical studies were conducted to evaluate the safety of Bextra and parecoxib sodium (an injectible form of valdecoxib), in
  • patients following CABG surgery and another study in patients following general surgery.
  • The first CABG study evaluated the safety of parecoxib sodium/Bextra 40 mg BID given for up to 14 days in 462 patients (311 on parecoxib sodium/Bextra and 151 on placebo).
  • The second CABG surgery study evaluated parecoxib sodium (40mg then 20mg bid) /Bextra 20 mg bid or placebo/Bextra 20 mg bid or placebo/placebo for up to 10 days in 1671 patients (544 receiving parecoxib/Bextra, 544 placebo/Bextra and 548 placebo/placebo).
  • Both CABG studies showed a higher rate of serious cardiovascular thromboembolic events (e.g. myocardial infarction, cerebrovascular accident) in the parecoxib sodium/Bextra treatment arm compared to the group of patients receiving placebo. This was not observed in a general surgery setting.
  • The EMEA has received new post-marketing reports of serious skin reactions, some with fatal outcome, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in patients receiving Bextra. Erythema multiforme has been reported in association with the use of parecoxib sodium.
  • The reported rate of these reactions appears to be greater for Bextra as compared with other COX-2 selective inhibitors.
  • Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first two weeks of treatment

If you have taken Bextra, and you have suffered a heart attack or stroke (or other serious complication), you have certain legal rights, and you may have a legal case against Pfizer, the maker of Bextra. You should contact a Bextra lawyer as soon as possible.

Our law firm is currently investigating potential cases against Pfizer, and if you think that you may have been harmed by Bextra, you are strongly encouraged to contact us. There is no charge, and no obligation. If we take your case, there is no fee for our services unless we win your case, or settle it in your favor.

On the other hand, if you fail to protect your legal rights now, you may lose the right to be compensated for your harm. (Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred).

Our firm has a great deal of experience in representing plaintiffs in “drug” cases, and in fact, is currently pursuing numerous cases against “Metabolife” for very similar injuries.

In addition, we have the resources to handle our own cases. This means that when you call our firm, you talk to your own lawyer who has been assigned to your own case.

Please contact us now (your privacy is assured). The secure form below only takes a couple of minutes to fill out, but if you are uncomfortable sending your information over the internet, please call our toll-free number at 800.921.1776 to speak to an attorney. The call is free, and there is no obligation. Act now, as delays can harm your case.

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