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Healthy Note: Be cautious of new medication 

New medication? Be cautious

Almost a quarter of prescription medications approved for patients in Canada over a 16-year period went on to be pulled from the market or to require a strongly worded safety warning to patients, a new study says.

In a “Research Letter” published online in the Archives of Internal Medicine, University of Toronto researcher Dr. Joel Lexchin looked at the 434 drug approvals that moved through Health Canada’s drug-safety arm from the start of 1995 to the end of 2010. Canada’s drug safety agency operates much like the U.S. Food and Drug Administration, so the study may reflect the state of drug safety in the United States as well.

About a quarter of the drugs approved in that period received a “priority review” — essentially, a fast-track deliberation. But when Canada’s drug safety agency approved a medication after such a review, the likelihood that the agency would have to take later safety action was about 50 percent higher than when a medication was subject to the customary deliberation period.

And more than 7 in 10 of those fast-tracked approvals were for drugs that did not even represent a “major therapeutic advance” over medications already available.

An accompanying editorial makes the study’s implications for patients and their physicians clear:

“Getting faster access to newer, less-thoroughly tested drugs is at best a mixed blessing,” wrote Thomas J. Moore, a researcher with the Institute for Safe Medication Practices in Pennsylvania. “For the first three years after approval, new drugs should carry a special warning akin to the black triangle used in Britain. It should be prominent and mean to every physician, ‘New Drug: Caution Indicated.’”

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