WASHINGTON — More than 100,000 Americans are inadvertently killed every year by prescription drugs--one of the leading causes of death in the country.
Some people die of drug reactions that are completely unexpected, the stuff of dramatic headlines and heavy lawsuits.
But the majority of such deaths are preventable, the result of mistakes or confusion about dosage, dangerous drug interactions from mixing medications or known allergic reactions. Some patients, especially the elderly, die because their liver or kidneys are so weakened by other illnesses that they cannot effectively process new drugs.
Alarmed by such drug-induced fatalities, the Food and Drug Administration is talking with leading drug companies, the American Medical Assn., hospitals and consumer groups seeking ways--together and individually--to further protect patients.
In a 150-page document expected to be released today, the FDA plans to unveil some of its initiatives. These include an upgraded computer network that will allow drug companies to report unexpected adverse reactions quickly and a new approach to language about the known side effects of prescription drugs that will give patients and doctors better and clearer warnings.
The actions were prompted in part by a study published in the Journal of the American Medical Assn. last year that concluded that adverse drug reactions are among the top six causes of death in the United States.
But other factors also propelled the issue to the top of the FDA's agenda. Under pressure from patients and politicians for faster access to promising medications, the FDA has in recent years moved drugs more rapidly through the regulatory pipeline. Such speed raises the risk once a drug is in widespread use.
Over the last two years, the FDA has recalled five drugs and moved to reevaluate several others, including the diabetes drug Rezulin, whose problems were detailed in a Times series last year, and the Parkinson's medication Tasmar, both of which have caused instances of liver failure. Whether Rezulin will remain on the market is still under debate.
"More can be done" overall to enhance public safety, said FDA Commissioner Jane E. Henney, who shortly after being confirmed by the Senate in October created a task force to study the drug approval process. She predicted in an interview that the effect of the changes "will be tremendous."
Some of the changes are underway, and others are in the talking stages.
