Fast-tracked new drugs more dangerous, study finds

Drugs rushed through Health Canadas approval process are significantly more likely to have serious safety problems once on the market than those that undergo a standard review, a new study has found.

The study found nearly 35 per cent of new drugs approved through the federal regulators priority review system later received serious safety warnings or were withdrawn from the market, compared with only some 20 per cent of those reviewed through the standard process.

Health Canadas standard approval involves reviewing drugs for 300 days, nearly double the 180 days taken in a priority review.

The length of time matters because it appears they missed things, said York University professor Joel Lexchin, who authored the study published Monday in the Archives of Internal Medicine.

The issue is, can you do as good a job evaluating that material in 180 days as you would in 300 days? Or are you going to miss things?

Drug companies can request that their new products be given a priority review. If the company provides convincing evidence that a drug is an effective treatment that isnt currently available, or that the drug is a significant improvement over existing treatments for serious diseases, Health Canada may speed up the review.

Health Canada lauded its drug approval system as one of the safest and most rigorous in the world.

Whether a drug is sent through priority or goes through the regular review process, safety is always our priority, said Health Canada spokesman Sean Upton.

In several cases, the drugs were given safety warnings just months after being approved through a priority review.

The Star is using the drugs generic names in this story. The Star was not able to reach the manufacturing companies for comment in time for publication.

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Fast-tracked new drugs more dangerous, study finds