There were rumors as early and May 2008 of a settlement. At that time the Wall Street Journal reported that attorneys for Pfizer were in negotiations with representatives of the plaintiffs. Pfizer did not confirm the settlements until the press release issued last week.

Of the $894 settlement, $745 million will go toward settling injury claims, $89 million for Bextra and Celebrex class action consumer fraud suits, and $60 million for state attorney general settlements over marketing practices related to Bextra.

The U.S Food and Drug Administration (FDA) asked Pfizer to withdraw Bextra in 2005, less than 4 years after its approval by the FDA. This was due to mounting evidence of increased cardiovascular risks and reports of a potentially fatal skin reaction called Stevens-Johnson syndrome.

Bextra and Celebrex are in the same class of drugs as Vioxx, which was previously withdrawn from the market in September 2004. Merck, the maker of Vioxx, has resolved most of the thousands of claims of injury by U.S. patients in a $4.85 billion settlement.

Celebrex remains as the only cox-2 inhibitor still available on the market today. According to Pfizer, state and federal courts have ruled that there is no reliable scientific evidence that Celebrex increases the risk of stroke and heart attacks. However, the FDA required all prescription non-steroidal anti-inflammatory drugs (NSAIDs), including Celebrex, to carry a “black box” warning about potential increased risk of heart attacks, stroke and gastrointestinal problems.

Originally posted 2008-10-22 11:04:09. Republished by Blog Post Promoter

Social Bookmarks

Hide Sites

No related posts.

Vioxx was approved by the FDA in 1999 for use in treating osteoarthritis. In 2001 Merck, the maker of Vioxx, began a 3 year study involving 2,587 people to show that Vioxx, which caused fewer gastrointestinal problems that older NSAIDs, could prevent the recurrence of colon cancer. However, Merck terminated the study 2 months early when the analysis of the data showed a doubled risk of heart attack and other cardiovascular issues, including death, in the study group receiving Vioxx over the placebo group.

Merck pull Vioxx from the market several months later on September 30th, 2004.

A follow up study was conducted to determine the lingering effects of long term use of Vioxx. This study was funded by Merck, which also provided the data, but was conducted independently. This analysis found that during the year following the halt of the 2004 study the risk of heart attack was 94% higher for those that took Vioxx (34) over those that took the placebo (18). They also found that the risk of stroke was more that double for the Vioxx group (19) over the placebo group (9).

In all, 76 Vioxx users suffered a stroke, heart attack, blood clot or died compared to 46 in the placebo group during that follow-up year.

Results of this study were published October 14th in the British medical journal The Lancet.

Merck issued the following statement in response to the Lancet study: “Merck believes that this post-hoc analysis using limited data from a prematurely terminated study needs to be interpreted very cautiously and in the context of the rest of the data from the extensive clinical development program for Vioxx.”

To be fair, it must be restated that older NSAIDs, such as naproxen and ibuprofen, also carry cardiovascular risks, along with risks of stomach bleeding and other complications.

Of the three cox-2 inhibitors, only Celebrex, manufactured by Pfizer, is still available in the U.S.

Originally posted 2008-10-20 15:12:28. Republished by Blog Post Promoter

Social Bookmarks

Hide Sites

No related posts.