Drugs have risks, but so does life, study notes

As Congress moves to improve drug safety, researchers suggest a new way to evaluate risks and benefits of some medications.

By Susan J. Landers, AMNews staff. May 28, 2007.

Washington -- Is it riskier to take a daily aspirin, drive a car or fight fires? Turns out they all carry about the same risk -- between 10.4 and 11 fatalities per 100,000 person-years, according to a study in the May/June Health Affairs, a policy journal published by Project HOPE.

Researchers from Tufts-New England Medical Center in Boston set out to compare the risks of taking each of six drugs to the risks people face at work, while traveling on various modes of transportation and during recreational activities. They reported those risks in terms of the mortality probability associated with each "person-year" of participation.

Their findings surprised them. For example, taking Vioxx (rofecoxib), which was withdrawn from the market in 2004, or Tysabri (natalizumab) for multiple sclerosis was comparable to or exceeded the risk of dying in a car crash, working as a truck driver or rock climbing.

On the other hand, it was less risky to take either drug than it was to drive a motorcycle, work as a logger or climb the Himalayas.

Assessing the risks and benefits of a medication is a scenario that plays out many times a day in physicians' offices. And concerns about drug risks currently are receiving attention on Capitol Hill, as Congress works on legislation containing several drug safety measures.

On May 9, the Senate approved its version of the measure, while a House companion also moves toward completion. Both include provisions intended to strengthen the Food and Drug Administration's ability to monitor drugs after they are approved.