Healthy Skepticism Library item: 1954

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

Reuters .
Pfizer beefs up arthritis drug warning
Australian Broadcasting Commission 2005 Aug 2
http://www.abc.net.au/cgi-bin/common/printfriendly.pl?http://www.abc.net.au/news/newsitems/200508/s1427707.htm

Keywords:
Celebrex Pfizer

Notes:

Ralph Faggotter’s Comments: When Celebrex first arrived on the market in a triumphant blaze of glory, it was heralded by all as a major advance in the treatment of arthritis. Over the intervening years the gloss has progressively worn off and now it appears to be just another NSAID, no better, and at high doses possibly worse in terms of adverse effects, than several others. One issue here is the process by which Celebrex was rushed through the FDA approval process before it had been properly studied.

Full text: Pfizer beefs up arthritis drug warning. 02/08/2005. ABC News Online [This is the print version of story http://www.abc.net.au/news/newsitems/200508/s1427707.htm] Last Update: Tuesday, August 2, 2005. 8:00am (AEST) Pfizer beefs up arthritis drug warning Pfizer says the label of its Celebrex arthritis drug has been changed to add a prominent warning of possible cardiovascular risks, such as an increased chance of heart attacks, in line with new warnings on other arthritis and pain drugs. The label will also carry a new warning that Celebrex, like older painkillers, can cause serious ulcers and gastrointestinal bleeding. Celebrex was developed to treat pain with a far lower risk of such bleeding than older treatments. But in a large clinical trial, Celebrex failed to prove significantly safer for the stomach than a far cheaper standard painkiller. Pfizer says the package insert label of the drug recommends it be prescribed “at the lowest effective dose for the shortest duration”. The company also says US regulators have approved a new use for the drug – treating ankylosing spondylitis, a form of arthritis of the spine that Pfizer says affects more than 400,000 Americans. “The fact that the FDA gave us a new indication shows they are confident in the safety of Celebrex,” Pfizer spokeswoman Mariann Caprino said. Sales decline Celebrex has been one of the company’s biggest products, though its sales have recently declined sharply due to safety concerns. Second-quarter revenue from Celebrex plunged 45 per cent to $US401 million – one reason the world’s largest drug maker expects a modest decline in company revenue this year. A federal advisory panel of doctors in February said Celebrex “significantly” raised the risk of heart problems and strokes. But the advisers to the US Food and Drug Administration recommended it remain on the market because of its benefits to arthritis patients. ‘Black box’ Pfizer is adding the new “black box” warnings at the request of the FDA. The agency has also asked the makers of dozens of other prescription and non-prescription painkillers, including Motrin, Advil and Aleve, to strengthen warnings about possible heart risks and potentially life-threatening gastrointestinal bleeding. The new warnings do not apply to aspirin. New York-based Pfizer in April withdrew a similar arthritis drug, Bextra, after US and European regulators said the risk of side effects, including a potentially fatal skin allergy, outweighed its benefits. Pfizer last month said its sales forces was holding back on fully promoting Celebrex again until it knew the warning language the FDA would require on the drug’s label. – Reuters © 2005 Australian Broadcasting Corporation Copyright information: http://abc.net.au/common/copyrigh.htm Privacy information: http://abc.net.au/privacy.htm