Some symptoms of Stevens Johnson Syndrome, which typically appear within a week of taking a new drug: s Rash, blisters, or red splotches on skin * Blisters in mucous membranes * Swelling of eyelids, red eyes * Persistent fever; flu-like symptoms * Co
February 14, 2005 08:16

Jane Webb, age 64, took Vioxx for years to help quell arthritis pain in her hands. In July, her doctor switched her to Bextra, another Cox-2 painkiller, to see if it would give her greater relief. A week into taking the new drug, the retired physics professor from Newport News, Va., noticed red blotches on her arms. She hadn't been told of any possible skin reactions, but was worried enough to see her dermatologist. The doctor diagnosed Stevens Johnson Syndrome, a rare illness most commonly triggered by medications. By the next day, the entire surface of her body was covered with blotches, welts and pimple-like bumps. "They were on my face, in my hair, in my ear," Webb says.

am in my early 50s. A year ago, I had shoulder surgery. I was prescribed Vioxx, and then Bextra for a year, to help relieve the pain in my other shoulder until I had an operation on it. Within a week of my second surgery, I was diagnosed with three pulmonary embolisms. I believe taking Bextra for a year prior to my second surgery may have played a part. What do you think? J.B., Illinois

Questions also have been raised about the safety of Pfizer Inc.'s Celebrex and Bextra, painkillers similar to Vioxx, and about whether they should remain on the market.

Wednesday, February 16, 2005 Lawsuits over Vioxx serve as a backdrop

The spotlight is likely to be on Pfizer on Wednesday when American drug regulators begin three days of hearings on COX-2 drugs, the class of arthritis and pain medicines that include the company's Celebrex and Bextra brands. . . For its part, Pfizer, despite slumping sales in recent months for Celebrex and Bextra, has kept both drugs on the market, saying there was no statistical evidence that either posed cardiac risks at normal dosages. A few lawsuits have been filed against Pfizer in recent months that echo many of the claims against Vioxx, but many plaintiffs' lawyers involved in the Vioxx cases say Pfizer appears to be on firmer legal ground than Merck. . . Pfizer's defenses could erode if the Food and Drug Administration decides after the hearings this week that Celebrex and Bextra are more dangerous than Pfizer has said.

Just days before a Food and Drug Administration advisory committee meets to discuss the future of Celebrex, Bextra and related arthritis drugs, the agency's Australian counterpart has introduced tough new measures to limit their use.

The maker of Celebrex and Bextra says the two prescription painkillers are safe, even as an official of another company that makes a similar drug says he believes all drugs in the same class may pose heart or stroke problems... Bextra remain safe and effective treatments for chronic pain... problems with Celebrex and Bextra have changed his mind...

At the FDA hearings, referring to Bextra, Wood asked a Pfizer pharmacologist, "Would you take this drug?"
The Pfizer employee declined to answer.

WellPoint Health Networks this week released a study that linked the COX-2 inhibitors Vioxx, Celebrex and Bextra to increased cardiovascular risk, " reinforcing findings of other trials" as two... FDA advisory committees on Wednesday plan to begin meetings on the medications, the AP/Long Island Newsday reports. The study involved the records of 7,232 patients ages 40 and older who took Vioxx, Celebrex or Bextra for at least 18 months and the records of 629,245 individuals of similar ages who did not take the medications.

Though a Food & Drug Administration advisory panel stopped short of pulling popular prescription painkillers from the market this week, the drugs' makers still face big headaches from lost sales and potential lawsuits based on research showing increased risk of heart attacks and strokes for some patients that use the drugs.

http://www.msnbc.msn.com/id/6994763/

Panel members expressed skepticism about some of Pfizer's study conclusions about Celebrex and Bextra, with some suggesting that they seemed incomplete or minimized the risks of the drugs. But Dr. Kenneth Verburg, a Pfizer vice president, insisted that the drugs had demonstrated benefits. He said the issue of whether there were cardiovascular risks should be studied further.

The wave of litigation across the country followed Merck's withdrawal of Vioxx from the market in September, after a study of high doses of the drug in cancer patients showed an increased risk of stroke and heart attack. Vioxx, Celebrex, and another Pfizer drug, Bextra -- all in a class of painkillers known as cox-2s -- had been under suspicion because of indications that they had a negative effect on the cardiovascular system.

Yesterday, an FDA advisorypanel recommended that Celebrex and Bextra remain on the market and narrowly voted to recommend that Vioxx be allowed to return to the market.

A panel of experts voted unanimously on Friday to advise the Food and Drug Administration that three leading painkillers - Celebrex, Bextra and Vioxx - can cause worrisome heart problems. But it also advised against banning the drugs, though by narrow margins in the cases of Bextra and Vioxx. NY TIMES

Several panel members said that patients in need of pain relief should first try naproxen, sold as Aleve by Bayer, before taking any of the three painkillers known as cox-2 inhibitors - Celebrex and Bextra, made by Pfizer, or Vioxx, made by Merck.

The panel voted 31 to 1 that Pfizer should be allowed to continue selling Celebrex, which members said was safer than the other two. The vote on Bextra was 17 to 13 with 2 abstentions, and 17 to 15 on Vioxx.

http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20050217005460&newsLang=en

Sabrina Johnson, a 7-year-old victim blinded by Stevens-Johnson Syndrome, was the first member of the public to address a joint meeting held today of its Arthritis Advisory and Drug Safety and Risk Management Advisory Committees. She asked the U.S. Food and Drug Administration (FDA) to require a warning label about SJS on Children's Motrin and any other drugs that can cause the disease. At a press conference also held today, she was joined by Public Citizen President Joan Claybrook, Stevens Johnson Syndrome Foundation founder Jean Farrell McCawley, Browne Greene with the Santa Monica, CA. law firm of Greene, Broillet, Panish & Wheeler, as well has her mother, Joan Brierton Johnson, and 12-year old brother, Travis Johnson

The FDA stopped the production of all television and print ads for painkillers Celebrex and Bextra, stating did not emphasize the drugs' health risks to consumers. Both drugs are associated with an increased risk of heart attack. Drug company Pfizer spent $70 million on Celebrex advertisements in the U.S. last year. Few ads were launched for Bextra. To learn more on this topic, be sure to also read the related article, Arthritis drug Bextra found to promote heart attacks and strokes.

Celebrex and Bextra, both made by Pfizer Inc., remained on the market, although their prescriptions plunged because of safety concerns.

Vioxx, Celebrex and another Pfizer drug, Bextra, have all come under fire recently for being linked to a higher incidence of cardiac problems in some patients.