“This is something that does happen from time to time,” says TIME medical columnist Christine Gorman. “Once in the marketplace, a drug is used by millions of people, but during clinical trials, it is tested on only a few thousand people. So occasionally a small risk will get missed in the trials.” Beyond highlighting the fact that safety watchdogs need to continually update the risk-benefit analysis of the drugs they approve, the Trovan incident also underscores a more ominous development. “We are running into more and more germs that are proving resistant,” says Gorman, “and as a result we are developing more powerful antibiotics. But with greater power often comes greater side effects.” Unfortunately, this dilemma is unlikely to be resolved soon.
No medicine is risk-free. A potent reminder of the fact came Wednesday when the Food and Drug Administration issued a restrictive public health advisory to the nation’s doctors concerning the popular antibiotic Trovan. The agency acted after receiving reports of 140 cases of liver damage among Trovan users since February 1998. Fourteen of the cases involved acute liver failure in which six patients died. The agency effectively pulled the prescription drug from general pharmacy shelves and instructed doctors to restricts its use to emergency situations in hospitals and nursing homes -- that is, in those instances where the need to combat a serious, life-threatening infection outweighs any liver risk.