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Bextra Lawsuit Information: FDA Bextra Recall Information

MedWatch - The FDA Safety Information and Adverse Event Reporting Program: Information from the FDA

After concluding that the overall risk versus benefit profile is unfavorable, the FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. This request is based on:

• The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that the FDA believes may be relevant to chronic use.
• Reports of serious and potentially life-threatening skin reactions,including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without prior history of sulfa allergy, and after both short- and long-term use.
• Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Patients currently taking Bextra should contact their physicians to consider alternative treatments.

The FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include boxed warning and a Medication Guide.

The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use.

The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, the FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.

Read the complete MedWatch 2005 Safety Summary, with links to the Public Health Advisory, Press Release and Questions and Answers at:http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Bextra

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If you have taken Bextra, and you have suffered a heart attack or stroke (or other serious complication including the above mentioned skin disorders), 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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