Bextra Lawyers - Information : Pfizer Bextra, Heart Attacks Attorneys, Strokes, Pain Drugs

Pfizer Withdraws Bextra from Market
Bextra News Alerts and Lawyer Updates

April 7, 2005 - Citing concerns regarding the risk of heart attacks, strokes, "life threatening" skin reactions, and other cardiovascular events the FDA requested that drugmaker Pfizer withdraw Bextra from U.S. and European pharmaceutical markets.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," said Dr. Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research.

The risks posed by Bextra outweigh its benefits, the FDA said.

"For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," Pfizer said in a statement Thursday.

If you or a loved one have suffered from the dangerous side effects of Bextra, you should consider receiving a free legal evaluation from an experienced Bextra lawyer.
------------------------------------------------------------------------------------------------------------December 17, 2004, Reuters - Doctors writing in a prominent medical journal on Friday recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks.

Pfizer Inc. on Friday (Oct. 15, 2004) said two small clinical trials showed heart bypass surgery patients taking Bextra, an anti-inflammatory in the same class as the recently withdrawn drug Vioxx, had a higher risk of stroke and heart attack.

In light of the increased focus on alternative treatment options for people with arthritis, Pfizer plans to conduct further studies to confirm the long-term cardiovascular safety profile of its anti-inflammatory drug Bextra.

Bextra is approved to treat pain from arthritis and, like Merck & Co.'s Vioxx, is a COX-2 inhibitor. A recent trial showed Vioxx doubled the risk of heart attack and stroke in arthritis patients who took the drug for more than 18 months.

The Vioxx withdrawal has cast a cloud over the entire class of COX-2 inhibitors, which includes Bextra, Celebrex and an experimental drug from Novartis AG called Prexige.

Recent evidence suggests that Bextra increased risk of stroke and heart attack when it was given to very high-risk patients who had undergone coronary bypass surgery.

As it relates to arthritis, Bextra has only been studied in these patients for up to a year.

Doctors said it is too early to quantify the potential risk of Bextra or of Pfizer's other COX-2 inhibitor Celebrex as neither have tested for long enough. Pfizer said it is conducting longer term trials in arthritis patients.

Pfizer's research studied use of Dynastat and Bextra in patients who had just had coronary artery bypass graft.

In these studies, there was an increase in cardiovascular events.

The first study involved 450 patients, 300 of which received Bextra and Dynastat. All the patients had the option of giving themselves morphine and opiates and everyone received low-dose aspirin.

In that trial, there was a trend showing the Bextra-Dynastat combination was leading to higher adverse event rates, though it wasn't statistically significant.

So, Pfizer decided to run an additional larger study to confirm the results.

The second study involved three groups of 500 patients each. The first received a placebo meant to look like Dynastat, then a sugar pill meant to look like Bextra and then the standard narcotic pain drugs like morphine. The second group received an indictable placebo, Bextra and the standard pain drugs. The third group got both Dynastat, Bextra and the other drugs.

All groups received their drugs for 10 days following coronary bypass surgery.

In the first group with the two placebos, 3 people suffered severe coronary events, 6 people in the Bextra group had these events and 11 people in the Bextra and Dynastat group suffered them.

The coronary bypass trials are ones that Dr. Eric Topol of the Cleveland Clinic Foundation and an early and outspoken critic of Vioxx, said he finds concerning as they show a cluster of heart attacks and strokes.

Pfizer also said it is updating its label on Bextra to strengthen a warning about a rare but serious skin reaction, Stevens-Johnson syndrome, that can occur mainly within the first two weeks of therapy.

BEXTRA NEWS & LAWYER UPDATES

SEC Asks Pfizer for Bextra, Celebrex Data
August 9, 2005, Forbes
Pfizer Inc. is responding to a request from the Securities and Exchange Commission for information and documents on its Bextra and Celebrex painkillers, the drugmaker said Tuesday in a filing.

Behind Bextra's Fall
April 21, 2005, Forbes
.... The memo states emphatically--and up-front--that Vioxx, Bextra and Celebrex all appear to be linked to an increased risk of heart attack and stroke. .... It (Bextra) It was pulled because it also has a serious risk of potentially lethal skin reactions.

Pfizer Agrees to Suspend Sales of Bextra, FDA Says
April 7, 2005, Bloomberg
Pfizer Inc. agreed to suspend sales of its Bextra painkiller at the request of U.S. regulators, making it the second painkiller to be pulled because of a link to heart risks after Merck & Co.'s Vioxx.

Doctors Say Avoid Pfizer's Bextra - Medical Journal
December 17, 2004, Reuters
Doctors writing in a prominent medical journal on Friday recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks.

New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks
November 10, 2004, Southwest Florida Herald Tribune (and New York Times, Subscription Required)
By GARDINER HARRIS, The incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos, according to preliminary results of a study presented yesterday at the American Heart Association meeting in New Orleans.

Pfizer Says FDA Warning Likely For Bextra
November 4, 2004, Forbes.com
According to Pfizer, Bextra can cause a rare but sometimes life-threatening drug reaction called Stevens-Johnson Syndrome in which the skin, mouth, and eyes can become horribly blistered.

EMEA to review COX-2 inhibitors
October 22, 2004, European Medicines Agency
Following the worldwide withdrawal of Vioxx (rofecoxib), the European Medicines Agency (EMEA) has been asked by the European Commission, as a precautionary measure, to conduct a review of COX-2 inhibitor medicines.

Pfizer Says Bextra, Heart Problems Linked
October 15, 2004, Pfizer Inc. on Friday said two small clinical trials showed heart bypass surgery patients taking Bextra, an anti-inflammatory in the same class as the recently withdrawn drug Vioxx, had a higher risk of stroke and heart attack.

The company also updated its warning that Bextra can cause a rare, but sometimes fatal, skin disorder called Stevens-Johnson syndrome to note that cases of the condition are being seen more often with Bextra than with other drugs in the same class.

More tests to be conducted on arthritis drug
In addition, Bextra has been studied in several surgical settings. In studies in general surgery, Bextra in combination with the investigational drug parecoxib showed no increased risk of cardiovascular thromboembolic events. However, in two trials in a high-risk surgery known as coronary artery bypass graft, an increase in cardiovascular events was observed in patients receiving Bextra alone or in combination with parecoxib, the company said.

Pfizer shares slammed by Bextra update
Pfizer shares slumped Friday after the Dow component said it would conduct additional studies on its Bextra drug treatment for arthritis pain to confirm its cardiovascular safety for patients.

Update 2: Pfizer to Test Safety of Pain-Drug Bextra
Pfizer Inc. said Friday it will conduct long-term cardiovascular safety tests on its pain drug Bextra in light of Merck & Co. pulling Vioxx, a drug in the same category.

After the announcement, Pfizer shares dropped $1.23, or 4.2 percent, to $27.85 in morning trading on the New York Stock Exchange.

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