Arthritis drug, Vioxx, a cox-2 inhibitor made by Merck & Co. Inc., has been cleared to return to market by Canadian health officials, nearly a year after it was pulled off the shelves amid fears of increasing cardiovascular problems.
Pfizer Inc.’s own arthritis remedy, Celebrex, was also cleared for sale. Celebrex is only a partial victory for Pfizer as their other arthritis medicine, Bextra, is to be denied entry into the Canadian market.
While Celebrex had remained on the market under restricted conditions, Pfizer pulled Bextra on its own in April, preceded by the voluntary withdrawl of Vioxx by Merck in September.
The vote was not unanimous among the Canadian panel, however. Vioxx was decided safe for the market by a vote of 12 to 1, with one dissenter citing evidence that Vioxx, especially at higher doses, was more of a danger to the cardiovascular system than Celebrex.
Andreas Laupacis, the panel’s chairman said:
“The majority vote felt that
A: Vioxx is clearly an effective anti-inflammatory drug and
B: studies have shows that it is associated with less gastrointestinal toxicity than many of the traditional NSAIDs,”
He continued to say that while the risk of heart disease was higher, it was no higher than other drugs already widely used.
Both Celebrex and Vioxx should come warnings about the associated risks, the panel said.
Though a US advisory panel affirmed the safety of Bextra, the Canadian panel decided there was not enough information to decide. Also, Bextra was associated with a rare skin disorder.
