Life-threatening skin reactions had been reported in patients. Health Canada yesterday joined U.S. and European regulators and ordered Pfizer to pull the drug Bextra off the market until concerns about its safety profile can be answered.
The move follows a public advisory last December indicating serious, potentially life-threatening skin reactions had been reported in patients taking Bextra.
In a conference call yesterday, a Health Canada official said the agency has found seven to nine cases of severe skin reactions associated with Bextra since 2002. None were fatal.
Regardless, anyone taking Bextra was encouraged to contact their doctor to discuss alternatives. The federal regulator also recommended new restrictions for Pfizer’s Celebrex, warning of possible increased cardiovascular risks.
“We disagree with their position but we’re complying with their request,” said Pfizer’s Michael Amos, adding the company hopes to persuading Health Canada to allow Bextra back on the market.
Introduced in Canada in 2002, Bextra is a member of the class of anti-inflammatory drugs known as COX-2 inhibitors, as is Celebrex. Bextra is used to treat arthritis and menstrual cramping.
When first approved in Canada in 1999, COX-2 inhibitor drugs were touted as “super aspirins” because they could relieve pain and inflammation like aspirin and other traditional (non-selective) NSAIDS, without causing stomach problems.
Since last September, however, the drugs have been embroiled in controversy
Since last September, however, the drugs have been embroiled in controversy. It began when Vioxx was pulled from the market by its maker after studies linked it to increased risk of heart attack and stroke. That’s when Health Canada’s scientific review began.
Since then, studies have suggested the risk is a class effect, meaning all the drugs in the class increase risk of cardiovascular events but, it is thought, to differing degrees.
Only one of the drugs, Celebrex, remains on the market in Canada.
At the Ottawa Hospital, however, Dr. Doug Smith, head of rheumatology and the Arthritis Centre, says although he’s pleased that the drugs are under scrutiny, he feels regulators are being particularly cautious after Vioxx.
“There are certain populations of patients who have benefited tremendously from this class of drugs. (But) with any drugs there are risks and benefits and you always have to weigh those,” Smith said.
RECENT DRUG WARNINGS
Dec. 17, 2004: Health Canada warns patients using Celebrex of increased cardiovascular risks when the drug is taken at daily doses of 400 mg and 800 mg.
Dec. 22, 2004: Health Canada releases another warning about selective COX-2 inhibitor NSAIDs. The agency states that evidence indicates that the use of them, in certain individuals, is associated with an increased risk of heart attack or stroke when compared to a placebo.
February 2005: FDA panel concludes Celebrex, Bextra and Vioxx all pose a risk to the heart, but should be available to consumers. April 7, 2005: FDA and Health Canada ask Pfizer to withdraw Bextra from the market.