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Panel recommends Vioxx return to market

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CTV News: Panel recommends Vioxx return to shelves
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Date: Fri. Jul. 8 2005 10:48 AM ET

The heart and stroke risks of taking Vioxx, which was removed from North American markets last year over concerns it causes heart failure, are equal to the common painkiller ibuprofen, experts selected by Health Canada said Thursday.

Ibuprofen is sold without prescription under names like Motrin and Advil, and has been available since the 1950s. It is known as a non-steroidal anti-inflammatory drug, or NSAID.

"The increased risk of cardiovascular disease caused by Cox-2 selective inhibitors seems similar to the increased risk associated with most NSAIDs," the panel's report said.

The panel -- a team of doctors and rheumatoid arthritis patients -- investigated claims that Vioxx, Celebrex and Bextra -- or Cox-2 inhibitors -- have caused thousands of people to die from heart attacks and strokes in the U.S. and Canada.

Vioxx was pulled from shelves last fall; Bextra was pulled in April. The Pfizer-made Celebrex is the only drug of that class that has remained on Canadian shelves.

The experts concluded that Vioxx should return to the market, since its effectiveness in treating pain outweighs its potential for harm. However, they added that patients should be provided with clearer labels, outlining the drug's negative side effects.

Vioxx-maker Merck Frosst Canada will have to request the drug be sold again before it could return to Canadian pharmacies.

The panel also decided that Celebrex should remain on the market, but gave a thumbs-down to Bextra, which was pulled from the Canadian and U.S. markets in early April.

Patients already prone to heart trouble are at a higher risk from Cox-2 inhibitors. A healthy person is at a low risk, but that risk increases with prolonged use.

Because ibuprofen has the same risks, the panel also made the sruprising decision to urge Health Canada to keep the drug behind the counter. They also recommended that more prominent information on its risks be provided to consumers.

"Health Canada should consider that ibuprofen only be sold after discussion with a pharmacist, and must ensure that the risks of cardiovascular events are prominently displayed in materials that individuals receive at the time they purchase the drug," the report says.

Marc Berthiaume, Health Canada's director of the marketed pharmaceuticals, responded to that recommendation by noting that individual provinces decide which drugs should be sold over-the-counter, and which drugs can be made more difficult to buy. But he said Health Canada will pass on the panel's recommendation to the provinces.

Health Canada said in a press release Thursday it will "immediately implement many of the panel's recommendations."

"The public can rest assured that Health Canada will continue to act in the best interests of protecting the health of Canadians," the agency said.

In the short-term it will take action to:

  • Alter labels on NSAIDs like Motrin and Advil to show updated patient safety information.
  • Continue its assessment of the drug Bextra, and whether it should return to the Canadian market.
  • Conduct further research on the current over-the-counter availability of ibuprofen products and their long-term effects.
  • Establish standards for risk and health benefit information on NSAID product labeling.

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