Expert panel recommends Vioxx return to market, issues warning on ibuprofen

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Expert panel recommends Vioxx return to market, issues warning on

ibuprofen

Dennis Bueckert

Canadian Press

July 7, 2005

OTTAWA (CP) - An expert panel is recommending that Health Canada allow

the controversial painkiller Vioxx back onto the market, while sounding

a surprise warning about a much older medication for pain and fever,

ibuprofen.

By a 12-1 vote, panel members concluded the benefits of Vioxx in

providing pain relief outweigh the increased risk of heart attack and

stroke. Merck withdrew the drug from the market last year due to

evidence of that risk.

The panel unanimously recommended that Celebrex continue to be sold,

for similar reasons, but gave thumbs down to a third drug in the same

class, Bextra.

Vioxx, Celebrex and Bextra, known as -2 selective inhibitors, are

sold by prescription to relieve pain from crippling conditions like

rheumatoid arthritis.

The panel concluded that these products pose similar risks to older

drugs known as non-steroidal anti-inflammatory drugs (NSAIDs), of which

ibuprofen is one.

The risk associated with each of the drugs is extremely low for a

healthy person. But the risk increases with prolonged use, and for

patients in a weakened state.

In a surprise finding the panel suggested that ibuprofen, sold under

the brand names Advil and Motrin, be kept behind the counter in

pharmacies, and sold with new warnings about risks of cardiovascular

disease.

Ibuprofen has been sold in Canada since the 1950s. -2 inhibitors

were introduced in the late 1990s.

The panel had not been asked to evaluate ibuprofen but came across

evidence of its dangers while evaluating the -2 inhibitors.

Although ibuprofen is intended for short-term relief of pain and fever,

the panel suggested that the drug is in reality being used chronically

and at high doses.

" 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, " says the panel

report.

It's now up to Health Canada to decide if it will accept the

recommendations.

In June, the panel held public meetings at which patients, drug

manufacturers and Health Canada officials discussed the risks and

benefits of the drugs.

Currently Celebrex is the only -2 inhibitor on the market in Canada.

Pfizer suspended sales of Bextra due to concerns about a rare skin

disorder as well as cardiovascular risks.