Canadian Panel Votes Against Bextra Due to Increased Risk of Serious Skin Reactions

On July 7, 2005, a panel of medical experts advised Health Canada officials that, in its opinion, the arthritis drug and painkiller Vioxx be allowed to be marketed once again in Canada.

In September 2004 Merck withdrew Vioxx worldwide after clinical tests showed that patients taking the Vioxx for more than 18 months had an increased risk of developing cardiovascular problems such as heart attacks and ischemic strokes.

The Health Canada advisory panel voted 12 to 1 in favor of allowing Vioxx to return to the market in Canada.  Their recommendation will be reviewed by Health Canada, which said that its review would pay close attention "to the safe labeling issued raised by the panel."

Earlier this year, a panel of outside experts narrowly voted to recommend to the FDA to allow Vioxx back on the U.S. market.

After this Health Canada advisory panel vote in favor of Vioxx, a Merck spokesman commented that the drug company has not decided, yet, whether to bring Vioxx back to the Canadian market or any other market. He said, further, that Merck will discuss the matter with Health Canada, as well as the FDA, in the near future.

The Health Canada advisory panel also voted unanimously that Celebrex remain on the market in Canada.  This panel, however, voted 8 to 5 against Bextra being returned to the Canadian market because "there was not sufficient information available about cardiovascular risk." The panel members voting against Bextra also stressed the risk of rare but potentially fatal serious skin reactions associated Bextra, namely Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Erythema Multiforme (EM).

The maker of Bextra, Pfizer, withdrew Bextra in April 2004 from all markets after the FDA said "the overall risk vs. benefit profile for the drug is unfavorable." Pfizer said at the time of the Bextra recall that the drug company disagreed with the FDA’s assessment of Bextra’s safety profile.

(Posted by: Tom Lamb)