Warnings need to be strengthened for the anti-inflammatory ibuprofen, and the controversial drug Vioxx should be allowed back on pharmacy shelves, an expert panel advised Health Canada on Thursday.
Ibuprofen carries as much risk of heart attacks and strokes as Vioxx and should therefore be moved behind the counter in pharmacies where patients would need to ask for it, panellists said.
- INDEPTH: Arthritis drug concerns
The independent panel was convened to weigh the risks and benefits of three COX-2 inhibitors: Vioxx, Celebrex and Bextra. The medications are prescribed to relieve pain from conditions such as rheumatoid arthritis.
The COX-2 drugs became some of the most commonly prescribed in Canada after they were promoted as causing fewer ulcer problems than traditional arthritis drugs.
Merck withdrew Vioxx from the market last year after clinical trials showed the drug increased the risk of heart attacks and strokes. The move cast doubt on the safety of all COX-2 inhibitors.
In a 12-1 vote, panellists said Vioxx should be brought back on the market in Canada for the majority of healthy people. The risk increases at higher doses, prolonged use and for those already predisposed to cardiovascular problems.
Health Canada said there is no clear reason not to allow Vioxx to return to the market. Merck said it has not yet decided whether to seek approval to resume sales in Canada or elsewhere in the world. In the U.S., the company faces several lawsuits from Vioxx users.
The panel unanimously endorsed keeping Pfizer Inc.'s Celebrex on sale.
They recommended 8-5 against allowing sales of Pfizer's Bextra, arguing there is not enough data on its heart risks, and it may increase the risk of a serious skin disorder.
As with any drug, the decision to take Vioxx should be discussed between a patient and his or her physician, panel chair Dr. Andreas Laupacis told reporters.
The panel also concluded the risks of heavy use of ibuprofen were underestimated.
The non-steroidal anti-inflammatory (NSAID), sold as Advil or Motrin, was approved for short-term relief of pain and fever but is often taken chronically at high doses, they said.
- FROM JUNE 9, 2005: Return COX-2s to market: arthritis patients to Health Canada panel
- FROM DEC. 23, 2004: FDA recommends restrictions on use of Celebrex, Bextra
"It is a provincial matter," said Dr. Marc Berthiaume, director of the marketed pharmaceuticals division at Health Canada. "What Health Canada plans to do is to inform provincial authorities of the recommendation."