Healthy Skepticism Library item: 7176
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Richwine L.
Drug reviewers question Pfizer pain drug data
Yahoo Finance 2006 Nov 29
http://biz.yahoo.com/rb/061128/pfizer_celebrex.html?.v=2
Abstract:
U.S. drug reviewers have questioned Pfizer Inc.‘s (NYSE:PFE – News) data showing the pain reliever Celebrex was as effective as an older drug in treating juvenile rheumatoid arthritis, a summary released on Tuesday said.
The Food and Drug Administration will ask an advisory panel that meets Wednesday if the agency should expand the approved uses of Celebrex to include children as young as 2 with rheumatoid arthritis.
The blockbuster prescription drug is part of the COX-2 class that has been linked to an increased risk of cardiovascular problems and included Merck & Co. Inc.‘s (NYSE:MRK – News) withdrawn Vioxx.
A Pfizer trial found Celebrex, known generically as celecoxib, worked as well as naproxen in treating children with rheumatoid arthritis.
“Nonetheless, there are limitations to the design of this non-inferiority trial that raise questions about whether it provides adequate evidence of efficacy of celecoxib” in juvenile rheumatoid arthritis, FDA staff reviewers said in a summary prepared for the panel meeting.
Naproxen is sold generically and under the brand name Aleve as an over-the-counter drug. Some forms are sold by prescription.
The risks of long-term Celebrex use in pediatric patients are unknown, the FDA reviewers said. Celebrex carries a warning that it may raise the chances of serious and possibly fatal heart problems, as may other non-steroidal anti-inflammatory drugs (NSAIDs) such as naproxen used to fight pain.
The panel will be asked “to assess the value of employing this treatment in the face of an unclear level of risk” and if further study is needed, the FDA staff said.
The uncertainty about long-term cardiovascular risks is “shared by all the medicines used to treat arthritis in children,” said Dr. Gail Cawkwell, Pfizer’s senior medical director.
The study design Pfizer used is standard for testing such treatments, she added.
About 30,000 to 60,000 U.S. children have rheumatoid arthritis, which can cause severe joint swelling and pain, decreased range of motion and growth abnormalities, the FDA summary said.
Approved drugs “may provide limited efficacy or intolerable side effects” for some patients, the FDA staff said.
Celebrex already is FDA-approved for various types of arthritis pain and other conditions. Use in children was limited to less than 1 percent of all Celebrex prescriptions dispensed from 2002 through June 2006, an FDA analysis said.
While doctors can prescribe Celebrex to children when they think it is appropriate, winning approval for juvenile rheumatoid arthritis would allow Pfizer to promote that use.
The company said, however, it had no plans for consumer-directed advertisements for that purpose but was “working with the FDA to determine the most appropriate means to share data that doctors and patients may find useful.”
If it does not win approval, Pfizer is “open to any label changes” that the FDA requests, a company statement said.
Celebrex sales have rebounded since the safety controversy erupted. Pfizer said last month the drug’s third-quarter sales jumped 20 percent from a year earlier to $537 million.
The company received an added six months of exclusive marketing time for Celebrex in exchange for the juvenile rheumatoid arthritis study.
Summaries from FDA staff and Pfizer can be found at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4252b1-00-i ndex.htm.
Shares of New York-based Pfizer rose 7 cents to $27.04 in afternoon trading on the New York Stock Exchange.
