June 7, 2001 - Trovan Rx Now Comes With Serious Warning
On Wednesday the Food and Drug Administration (FDA) issued a restrictive public health advisory to the nation's doctors concerning the popular antibiotic Trovan. The agency received reports that since February of 1998 Trovan users have reported 140 reported cases of liver damage, ranging from the slight to severe.
Six patients who were taking Trovan died as a result of serious liver complications and fourteen had a complete liver failure. The FDA effectively pulled the drug from the nation's pharmacies. It also limited the drug's use only to those instances where the need to treat a serious, life-threatening infection outweighed any liver risk. The agency also instructed doctors to restrict the use of Trovan to emergency situations only.
"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" said TIME medical columnist Christine Gorman.
"We are running into more and more germs that are proving resistant," continued Gorman, "and as a result we are developing more powerful antibiotics. But with greater power often come greater side effects that are hard to resolve."
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