Bextra Stevens Johnson Syndrome

Bextra and Stevens Johnson Syndrome
Bextra Lawyer, Bextra Lawsuit, Bextra Recall, Bextra Side Effects, Skin Rash

Study Shows Bextra Causes Stevens Johnson Syndrome

Bextra and other non-steroid anti-inflammatory drugs such as Advil has been linked to Stevens Johnson Syndrome, a potentially fatal skin rash.

About Stevens Johnson Syndrome

Stevens-Johnson syndrome (SJS) is an immune-complex–mediated hypersensitivity complex that is a severe expression of erythema multiforme. It is now known also as erythema multiforme major. SJS typically involves the skin and the mucous membranes. While minor presentations may occur, significant involvement of oral, nasal, eye, vaginal, urethral, GI, and lower respiratory tract mucous membranes may develop in the course of the illness. GI and respiratory involvement may progress to necrosis. SJS is a serious systemic disorder with the potential for severe morbidity and even death.

Stevens Johnson resources:

Stevens Johnson Foundation
emedicine.com
MedlinePlus, U.S. National Library of Medicine
Family Village Library

Bextra Removed From Market at Request of FDA

On April 7, 2005, the Food and Drug Administration requested that Pfizer halt sales of the drug Bextra due to safety concerns related to cardiovascular, gastro-intestinal and skin risks. Pfizer complied with the request.

The Bextra Team™, Highly Experienced Lawyers Fighting for Victims of Bextra

We are a team of lawyers with a long track record of taking on large pharmaceutical companies like Pfizer. We only handle individual claims with serious damages. Serious claims require individual time and attention. If you believe you may have a claim, contact us today toll free at 314-650-5217 for an immediate, free phone consultation.

Free Bextra Case Evaluation

It may be that you are entitled to compensation due to injuries suffered from the drug Bextra. If you suffer from Stevens Johnson Syndrome and have taken Bextra, please contact us for a free case evaluation.

Our lawyers will provide you with a free case evaluation. Simply click on the following link to complete a short form and one of our attorneys will contact you today. We evaluate cases nationwide. Click here to complete a short form

Official FDA Announcement on the Withdrawal of Bextra

Today, the Food and Drug Administration (FDA) is announcing that it has asked Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. 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 a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of cardiovascular (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, 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.

In reaching these decisions, FDA has carefully considered the available data on all of the NSAIDs. The Agency has also considered presentations, discussions, and votes from the joint public meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee held on February 16, 17, and 18, 2005 to discuss the CV safety concerns for these drugs along with their overall risk-benefit.

Specifically, FDA is requesting the actions listed below and will work closely with the manufacturers to ensure their timely implementation.

BEXTRA (valdecoxib tablets)

FDA has concluded that the overall risk versus benefit profile is unfavorable and has requested that Pfizer, the manufacturer of Bextra, voluntarily withdraw Bextra 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 CV events in short-term coronary artery bypass surgery (CABG) trials that 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 a prior history of sulfa allergy, and after both short- and long-term use.
Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency.

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

Source

Bextra News

Senate considers bill to allow Vioxx, Bextra victims to sue

By NIKI SULLIVAN
Associated Press Writer

SALEM, Ore. (AP) - A bill that would expand the number of people who can sue because of health problems caused by Vioxx and Bextra got its first hearing in the Senate Thursday. More>>>

Bextra Users: What's Next?

BLOOMINGTON -- In 16 days, Paula Hardy of Bloomington wants to do more than cry.

In 16 days, she completes her prescription of Bextra, the painkiller she takes to help relieve joint inflammation from rheumatoid arthritis. Because Bextra was pulled from the market last Thursday, Hardy and other Bextra users can't get a refill when their prescriptions run out. More>>>

Pfizer Halts Bextra Sales at FDA Request

By LAURAN NEERGAARD, AP Medical Writer
Yahoo! News

WASHINGTON - The blockbuster painkiller Bextra was yanked off the market Thursday, and the government ordered that 19 other popular prescription competitors — from Celebrex to Mobic to high-dose naproxen — carry tough new warnings that they, too, may increase the risk of heart attacks and strokes. More>>>

Pfizer takes painkiller Bextra off market

By Connie Cass / Associated Press

WASHINGTON -- The painkiller Bextra was taken off the market Thursday, and the government wants other drugs in the same class to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them. More>>>

FDA, Pfizer Pull Support for Bextra

RedNova

The Food and Drug Administration and the drug company Pfizer are telling patients to stop taking Bextra, a drug prescribed by doctors to relieve arthritis pain and inflammation. More>>>

Pfizer's Outlook Darkens on FDA Bextra Ban

By THERESA AGOVINO, AP Business Writer

NEW YORK - Pfizer Inc.'s earnings are likely to slump further this year and its recently released plan to return to double-digit earnings growth in 2006 and 2007 could be in jeopardy because of Thursday's decision by federal regulators to ban the sale of Bextra, one of its blockbuster pain relievers, analysts said. More>>>

FDA Puts Bextra on Do-Not-Sell Drug List

RedNova

Apr. 8--Pfizer Inc. pulled the pain pill Bextra from the market Thursday at the request of the Food and Drug Administration, which also called for stronger warnings of heart risks for a broad swath of pain treatments.

Apr. 8--Pfizer Inc. pulled the pain pill Bextra from the market Thursday at the request of the Food and Drug Administration, which also called for stronger warnings of heart risks for a broad swath of pain treatments. More>>>

Click here for a free case evaluation by our lawyers of your BEXTRA case

FDA Questions and Answers on Bextra

Questions and Answers:
Strengthened Warnings on Bextra

What did FDA do?

FDA approved a new label with upgraded warnings for Bextra. The new label:

Strengthened the warning about the possibility of serious skin reactions, including two types of reaction that can result in death (Steven-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN))

Added a new warning about possible heart and blood clotting problems, particularly in patients who have just had coronary artery bypass graft surgery (CABG)

Is Bextra safe for me to take?

Your physician can help answer this question. While all drugs have risks, FDA believes that, based on what we know now, the overall benefit of Bextra outweighs the risk when used in properly selected patients as directed in the approved labeling.

FDA will continue to monitor the side effects related to Bextra and take additional actions as appropriate. As we have previously announced, FDA will also hold a public advisory committee meeting in February to discuss safety concerns of all marketed COX-2 and related drugs, including Bextra.

What is Bextra?

Bextra is a type of pain medication, called COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs), used to treat arthritis and menstrual pain.

Why did FDA strengthen the warnings?

Despite earlier warnings in the Bextra label, the FDA is still receiving reports of serious, potentially fatal, skin reactions such as SJS and TEN. Patients known to have an allergy to sulfa products should not take Bextra.

Other COX-2 selective NSAIDs and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but these serious side effects appear to occur more often for patients taking Bextra than for other COX-2 agents.

In addition, results from a new study of more than 1500 patients who had just had cardiac surgery show that patients treated with Bextra for pain were more likely to have heart and blood clotting problems than other patients who did not receive any drug. These problems include heart attack, stroke, deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung).

What does this mean for me?

Talk to your doctor if you have any concerns about the medications you are taking.

You should not take Bextra if you are allergic to medications that contain sulfa.

You should not take Bextra if you have just had CABG surgery.

You should stop taking Bextra and call your doctor immediately if you develop a rash or sores in your mouth while taking Bextra. Rashes and other skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur at any time during therapy.

You should also call your doctor if you develop chest pain.

What other problems should I know about?

Bextra can also cause stomach ulcers. You should stop Bextra and call your doctor if you have any of the following:

Burning pain in your stomach

Dark stools or blood in your stools

Vomit that looks like blood or coffee grounds

Why did FDA take this action?

Patients need to have all the information available about the drugs they are taking and their potential side effects, so they can stop the medication and seek immediate treatment if needed.

To report any unexpected adverse or serious events associated with the use of Bextra, you can contact Pfizer, Inc., at 1-800-323-4204 or FDA MedWatch program at 1-800-FDA-1088 or on the Internet at http://www.fda.gov/medwatch/index.html