Canada bans Pfizer arthritis drug Bextra
Canada banned Pfizer Inc.'s arthritis drug Bextra on Friday because of risks of heart attacks and strokes.
Bextra sales in Canada were suspended by Pfizer in April at the government's request.
"Following a review of safety information, Health Canada is informing the public that Bextra, an anti-inflammatory drug used to treat arthritis and pain, will not return to the market," the government said in a statement.
"The decision to stop the sale of Bextra is based on information submitted by the manufacturer, Pfizer Canada Inc., and consultations with external experts and the public. Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use."
Pfizer's suspension of sales in April was simultaneous with similar actions in the United States and Europe, after regulators voiced concerns over cardiovascular risks.
Bextra racked up global sales of $1.3 billion in 2004, and in May this year Pfizer expressed confidence about the drug's eventual return to the market in the United States because it was needed by patients.
Health Canada initiated a review of Bextra and related drugs following Merck & Co. Inc.'s withdrawal of a similar drug, Vioxx, in September 2004.
Bextra and Vioxx are both COX-2 selective inhibitor non-steroidal drugs, and the review looked at other non-steroidal anti-inflammatory drugs, or NSAIDs too. Examples of traditional NSAIDs are aspirin, ibuprofen and naproxen.
The Health Canada review concluded that COX-2s and all other NSAIDs are associated with an increased risk of cardiovascular problems when high doses are used for long periods.
"However, the exact nature of that increased risk may differ from one product to another," it said.
As for Vioxx, it remains suspended, but the government said in July that it saw no reason not to allow it back on the market if Merck requested it.
Bextra sales in Canada were suspended by Pfizer in April at the government's request.
"Following a review of safety information, Health Canada is informing the public that Bextra, an anti-inflammatory drug used to treat arthritis and pain, will not return to the market," the government said in a statement.
"The decision to stop the sale of Bextra is based on information submitted by the manufacturer, Pfizer Canada Inc., and consultations with external experts and the public. Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use."
Pfizer's suspension of sales in April was simultaneous with similar actions in the United States and Europe, after regulators voiced concerns over cardiovascular risks.
Bextra racked up global sales of $1.3 billion in 2004, and in May this year Pfizer expressed confidence about the drug's eventual return to the market in the United States because it was needed by patients.
Health Canada initiated a review of Bextra and related drugs following Merck & Co. Inc.'s withdrawal of a similar drug, Vioxx, in September 2004.
Bextra and Vioxx are both COX-2 selective inhibitor non-steroidal drugs, and the review looked at other non-steroidal anti-inflammatory drugs, or NSAIDs too. Examples of traditional NSAIDs are aspirin, ibuprofen and naproxen.
The Health Canada review concluded that COX-2s and all other NSAIDs are associated with an increased risk of cardiovascular problems when high doses are used for long periods.
"However, the exact nature of that increased risk may differ from one product to another," it said.
As for Vioxx, it remains suspended, but the government said in July that it saw no reason not to allow it back on the market if Merck requested it.
posted by Chris Placitella at 8:11 AM
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