Adverse Drug Effects


The nation’s medicine chest is brimming with powerful new drugs. But each year, millions of Americans become sick or even die after adverse reactions to them.

One little tablet forever changed Rosemary Porta’s life. The 58-year-old Pennsylvania school librarian went to her doctor in January 1999 complaining of chest congestion. Because she was allergic to amoxicillin, her physician prescribed a new antibiotic, Trovan.

As she took the medication over the next several weeks, she began to suffer from nausea, blurry vision and severe exhaustion that left her bedridden. One morning, she awakened to discover the whites of her eyes had turned yellow, her skin had an eerie, incandescent glow and her urine was dark orange–the hallmarks of catastrophic liver failure.

She was rushed to the hospital, where she clung precariously to life. Finally, in April, she had a life-saving liver transplant. But the episode took a heavy toll on Porta’s health. She now takes a battery of drugs to keep her body from rejecting the donor liver. The drugs themselves cause side effects, such as tremors, and she has experienced three frightening rejection episodes. And even an inconsequential medical problem, like a yeast infection, can escalate into a crisis. “I’m living on borrowed time,” says Porta. “And all I did was take a pill.”

The Food and Drug Administration has since limited Trovan to treating life-threatening infections in hospitals or nursing homes. The action came too late for Porta, who never realized the medicine her doctor dispensed could be hazardous. Like many Americans, she took drug safety for granted.

Adverse drug reactions have reached epidemic proportions, killing more people each year than die on the nation’s highways, and doing serious damage to millions more. This problem has taken on special significance recently: The FDA has pulled 10 drugs off the market in the past three years for safety reasons, which is unprecedented in the agency’s history. Nearly 20 million patients, almost 10% of the U.S. population, were estimated to have been exposed to these drugs before their removal, according to a 1999 editorial in the Journal of the American Medical Assn.


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