WASHINGTON -- Hoping to decrease the 100,000 patient deaths caused by medication side effects each year, the Food and Drug Administration is hunting new, safer ways to help patients use powerful drugs.
Much depends on getting doctors, other health workers and patients themselves to help, FDA Commissioner Jane Henney said Monday in releasing a 150-page report on drug safety."Safe doesn't mean no risk," Henney stressed, explaining that both doctors and patients must understand that while every drug has side effects, there are ways to minimize risk.
Some side effects are largely unavoidable, like the fact that cancer chemotherapy can leave patients vulnerable to dangerous infections.
Others are a surprise. New drugs are tested on only a few hundred to a few thousand patients before they're sold to millions, meaning rare side effects that didn't show up in small clinical trials can wind up hurting hundreds of people. But doctors aren't required to report side effects to the FDA, which has only about 80 employees to monitor the more than 3,000 prescription drugs sold. The agency has had to ban five drugs since September 1997.
Still, experts say most side effect-caused deaths are preventable.
Doctors may prescribe the wrong drugs -- sometimes confusing those with similar names -- or wrong dosages. The medicine may interact dangerously with another drug the patient takes but forgot to mention.
Busy physicians often don't fully read FDA-approved prescription labels to learn all the side effects, and it's hard to remember warnings for so many drugs. So Henney announced plans Monday to improve patient safety. Part of the job is the FDA's. Plans include:
Seeking $15.3 million from Congress this year to improve drug monitoring, including an upgraded computer network to speed reports of side effects.
Designing a new drug label to help doctors find safety information quickly instead of having to fumble through pages of fine print.
Exploring how to limit early sales of certain drugs, so that fewer people risk unexpected side effects.