NEW YORK, April 7, 2005 (PRIMEZONE) -- Parker & Waichman, LLP commends the FDA's decision to remove Bextra from the U.S. market. In 2004, Parker & Waichman, LLP and Seeger Weiss LLP filed the first Bextra heart attack case in the United States. The case was filed in the Supreme Court of the State of New York, County of New York, against Pfizer Inc. (NYSE:PFE). The suit was on behalf of the estate of a 46 year old man who died of a heart attack while using Bextra. The suit claims that Pfizer has not acted responsibly and has failed to adequately warn consumers about the potential side effects associated with Bextra. Parker & Waichman, LLP and Seeger Weiss LLP intend to file additional suits in the coming weeks on behalf of Bextra users who have suffered heart attacks, strokes and serious skin reactions known as Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. Current and former Bextra patients seeking legal help can visit www.bextralegalhelp.com or www.yourlawyer.com/practice/contact.htm?topic=Bextra.
Today, the FDA and European regulators formally asked Pfizer to suspend sales of Bextra in the United States and Europe. As a result, Pfizer announced it would halt sales of the drug in the United States and the European Union countries immediately. The FDA stated that the risks posed by Bextra outweigh its benefits. These risks include a high rate of heart attacks, strokes and Stevens Johnson Syndrome.
In November 2004, a study was presented at the American Heart Association meeting in New Orleans indicating that the incidence of heart attacks and strokes in patients taking Bextra (valdecoxib) was twice that of the placebo. This study included 5,930 patients from 12 trials and found 2.19 times the number of heart attacks or strokes among patients given Bextra compared with those given placebos. This incidence rate is actually higher than that of Vioxx (www.yourlawyer.com/practice/contact.htm?topic=Vioxx ), which was withdrawn by Merck (NYSE:MRK) in September 2004.
In February, the New York Times reported that 10 of the 32 government drug advisers who voted to keep Bextra and the other COX-2 drugs on the market have consulted for pharmaceutical companies. If these 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn.
"The risks associated with Bextra have been known for quite some time," commented Jerrold S. Parker, one of the founding partners of Parker & Waichman, LLP, a law firm committed to advocating for Bextra victims' rights. "We are encouraged that the drug is off the market but feel sorry for the thousands of Bextra users who have needlessly suffered. The fatal side effects of Bextra are nothing new and we believe this withdrawal was long overdue. We will continue to bring claims on behalf of Bextra victims whose lives have been impaired or lost." All Bextra users can receive a free legal case evaluation by visiting: www.bextralegalhelp.com or www.yourlawyer.com/practice/contact.htm?topic=Bextra.
Bextra was approved by the FDA in 2001 for the treatment of osteoarthritis, adult rheumatoid arthritis and dysmenorrhea. In October, 2004, Pfizer acknowledged that two clinical trials indicated that Bextra could increase the risk of heart attacks in heart bypass surgery patients.
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