Liver injury is the major reason drugs are withdrawn from the market, the FDA Consumer (www.fda.gov/fdac) reports. The online magazine, published by the US Food and Drug Administration, says that rare, liver-related drug problems often go undetected during clinical trials. The FDA says that unless a drug is used to treat a life-threatening illness, a significant rate of severe injury (>> 1 in 50 000 exposures) can lead to limitations on its use, withdrawal from the market or a warning. Other drugs have “significant limitations on their use” because of potential liver damage. These include acetaminophen and the antimicrobial drug trovafloxacin. The limitations range from warnings to dose restrictions and monitoring by a physician.
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