Current Arthritis News and Research » FDA http://4-arthritis-info.com Regular Updates on the Many Forms of Arthritis Tue, 08 Nov 2011 17:30:28 +0000 en hourly 1 http://wordpress.org/?v=3.2.1 Pfizer Settles Bextra, Celebrex Lawsuits http://4-arthritis-info.com/pfizer-settles-bextra-celebrex-lawsuits/ http://4-arthritis-info.com/pfizer-settles-bextra-celebrex-lawsuits/#comments Mon, 17 Jan 2011 22:46:03 +0000 awesome http://4-arthritis-info.com/wp/?p=219 As a follow up to the last post, Pfizer announced last Friday that they have agreed to pay $894 million to settle 3 lawsuits that alleged Celebrex and Bextra harmed patients in the U.S. and defrauded consumers. The suits claimed that Bextra and Celebrex resulted in increased risks of heart attacks and strokes.

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Bextra and Celebrex are in the same class of drugs as Vioxx, which was previously withdrawn from the market in September 2004.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

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]]> http://4-arthritis-info.com/pfizer-settles-bextra-celebrex-lawsuits/feed/ 0 FDA Panel Recommends Approval of New Gout Drug http://4-arthritis-info.com/fda-recommends-approval-gout-drug/ http://4-arthritis-info.com/fda-recommends-approval-gout-drug/#comments Tue, 09 Dec 2008 20:31:15 +0000 awesome http://4-arthritis-info.com/wp/?p=294 I posted last month about a new gout drug being tested by Takeda Pharmaceutical. Based on the results of that testing a U.S. Food and Drug Administration (FDA) expert panel has recommended that febuxostat be approved. This would make febuxostat, to be marketed as Uloric, the first gout drug to be approved in over 40 years.

Until now, the only drug approved for treatment of gout was allopurinol, marketed under the name Zyloprim. Allopurinol prevents the formation of uric crystals that cause gout. However, allopurinol has some potentially fatal side effects which limits the amount that can be taken by gout patients.

Takeda had submitted Uloric to the FDA in 2005, but it was denied due to reports of more heart problems in patients taking it than in allopurinol. The recent tests were a response to those concerns, which found that there is no more risk for patients taking Uloric than those taking allopurinol. In addition, very little Uloric is eliminated in the urine which makes it safe for patients with kidney problems.

The trials showes that an 80mg dose of Uloric worked better than allopurinol and a 40mg dose worked just as well.

Takeda has offered to continue studies of Uloric after receiving FDA approval. Specifically, they will conduct a phase 4 clinical trial to compare Uloric to allopurinol for treatment of gout flare-ups.

The FDA panel has recommended that the FDA approve Uloric by a 12-0 vote. The FDA usually takes the advice of its panelists and will weigh the recommendation before making its final decision, which is expected to come by Jan. 16.

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]]> http://4-arthritis-info.com/fda-recommends-approval-gout-drug/feed/ 0 Arthritis Foundation Top 10: Passage of FDA Legislation on Drug Regulation and Safety http://4-arthritis-info.com/arthritis-foundation-top-10-passage-of-fda-legislation-on-drug-regulation-and-safety/ http://4-arthritis-info.com/arthritis-foundation-top-10-passage-of-fda-legislation-on-drug-regulation-and-safety/#comments Sat, 23 Feb 2008 21:10:31 +0000 awesome http://4-arthritis-info.com/wp/2008/02/23/arthritis-foundation-top-10-passage-of-fda-legislation-on-drug-regulation-and-safety/ The Arthritis Foundation recently came out with its list of the top 10 arthritis events for the year 2007. This series will focus on those events.

#1: Passage of FDA Legislation on Drug Regulation and Safety

The Food and Drug Administration Amendments Act of 2007 was signed into law by President Bush in [...] No related posts.]]> The Arthritis Foundation recently came out with its list of the top 10 arthritis events for the year 2007. This series will focus on those events.

#1: Passage of FDA Legislation on Drug Regulation and Safety

The Food and Drug Administration Amendments Act of 2007 was signed into law by President Bush in September. The result of the bill is to increase the FDA’s authority to regulate drugs. This legislation renews two programs for five years that collect fees from drug and medical device manufacturers to defray the FDA’s expense in reviewing products. The FDA’s traditionally focuses on approval of new drugs, however, Congress also used the bill expand the FDA’s powers to police drug safety.

The bill gives the FDA the power both to require drug companies to conduct additional studies to further assess the safety of medicines and to mandate new label warnings when problems become apparent. It also requires companies to publicly release results of all clinical trials that show how well their drugs performed. The FDA also gains the ability to fine drug companies for not completing follow-up studies on their drugs after they’ve received government approval. Direct-to-consumer advertisements, such as television commercials, will now be more strictly regulated by the FDA. The agency can review drug ads and fine companies for false or misleading claims, but it cannot ban them.

Two pediatric drug programs also were reauthorized for five more years as part of this legislation. The Pediatric Research Equity Act of 2007 requires a drug or biologic manufacturer that submits an application to the FDA to also submit a pediatric assessment. The Best Pharmaceuticals for Children Act of 2007 grants an additional six-months of marketing exclusivity to a manufacturer of a drug in return for pediatric use studies and reports.

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