Should new drugs wear 'proceed with caution' labels?

About one-fourth of drugs approved in Canada over 16 years were later slapped with serious safety warnings or yanked from the market for safety reasons, an Archives of Internal Medicine article says. And an accompanying editorial advocates special labeling for new drugs for their first three years on the market, so doctors are reminded to prescribe with caution.

Of particular concern, author Joel Lexchin wrote, were drugs approved after priority review, a program akin to FDA's fast-track approvals in the U.S. Products launched after Health Canada's priority review were 50% more likely to end up with safety warnings, compared with drugs approved on the usual schedule.

And as the Los Angeles Times notes, the drugs that one might assume to be most risky--those fast-tracked for approval for life-threatening diseases such as cancer and HIV--were no more likely to surface as safety concerns than drugs fast-tracked for less serious illnesses.

Though regulators might be expected to accept bigger risks for cancer treatments and the like, it appeared that the tolerance for risk was equal across the board, even for so-called me-too drugs, the Times suggests.

"Getting faster access to newer, less-thoroughly tested drugs is at best a mixed blessing," the Institute for Safe Medication Practices' Thomas J. Moore wrote in the Archives editorial (as quoted by the Times). "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.' "

- read the LA Times story