| Roman Bystrianyk 2005-01-27, 6:02 am |
| Susan Heavey, "Group Calls on FDA to Pull Pfizer Pain Drugs", Reuters
UK, January 24, 2005,
Link:
http://www.reuters.co.uk/newsArticl...storyID=7411129
U.S. regulators should pull Pfizer Inc.'s arthritis drugs Celebrex and
Bextra from the market because they are too risky, U.S. consumer
watchdog group Public Citizen said in a letter on Monday.
In a formal petition to the U.S. Food and Drug Administration, Public
Citizen said the two drugs' potential to cause heart attacks and
strokes outweighed any possible benefit.
The letter, a copy of which was obtained by Reuters, is the latest
action following a series of warnings over heart problems connected to
both prescription and over-the-counter painkillers.
Merck Inc. pulled its arthritis drug, Vioxx, from the market in
September after a study showed its doubled the risk of heart attack and
stroke. Last month, the National Institutes of Health halted two
studies involving Celebrex and naproxen, a nonprescription painkiller
sold as a generic and under several brand names, including Bayer AG's
Aleve and Roche AG's Naprosyn.
Pfizer has kept Celebrex on the market but agreed to suspend consumer
advertising. It also placed a note on Bextra warning of increased risk
in patients who have just had heart bypass surgery.
The FDA has called on doctors to limit prescribing of Celebrex and
Bextra, and an FDA advisory panel of outside experts plans to meet for
an unusual 3-day meeting to discuss the entire class of drugs.
In its letter sent Monday, Public Citizen said Pfizer's drugs have not
been proven any safer than older non-steroidal, anti-inflammatory
painkillers, known as NSAIDs, like aspirin or naproxen. NSAIDs are
known to cause ulcers and other gastrointestinal problems that can
sometimes lead to death.
Celebrex and Bextra, chemically known as celecoxib and valdecoxib,
"present a unique risk with no unique benefits," Dr. Sidney Wolfe said
the letter.
FDA officials could not immediately be reached for comment.
Public Citizen researchers analyzed results from 14 randomized trials
involving all drugs in the class that includes Celebrex and Bextra --
known as Cox-2 inhibitors. They concluded they are all risky due to a
class effect that causes cardiovascular troubles.
The group also urged the FDA to reject two other pending Cox-2 drugs --
Novartis AG's Prexige and Merck's Arcoxia.
Arcoxia is approved in the European Union, but the FDA rejected the
experimental drug in October, requesting more data.
Novartis pulled its application for EU approval in November, saying it
would provide more data, and has said it is working to get the drug
approved in the United States.
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