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trials showed heart bypass surgery patients taking Bextra, an anti-inflammatory in the same class as the recently withdrawn drug Vioxx, had a higher risk of stroke and heart attack.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.