Trovan should be used only for patients in hospitals or nursing homes who have certain life-threatening infections for which the need for the antibiotic outweighs its liver risks, the Food and Drug Administration said in issuing the unusual restriction.
Manufacturer Pfizer Inc. has agreed to sell Trovan only to hospitals and long-term nursing care facilities.
If patients using intravenous Trovan are well enough to go home, doctors would give patients enough Trovan pills to complete their treatment rather than writing a prescription a regular drugstore would fill.
"It's the only way to get the message across that this really was not supposed to be used for the run-of-the-mill outpatient infection," said FDA drug chief Dr. Murray Lumpkin.
Since February 1998, 140 cases of liver damage have been reported among Trovan users. The FDA said in 14 cases, the drug apparently caused the most severe liver damage, called acute liver failure. Six patients died, three survived thanks to liver transplants, and three recovered without a transplant. Two others still are being treated.
The FDA maintains that Trovan's liver risks were not apparent in pre-market testing of the drug. Thus, the agency initially allowed the antibiotic to be sold as a broad treatment for everything from minor skin infections to severe hospital infections. Some 2.5 million people have used it.
Then the reports of liver damage began. Last month, the European Union warned Europeans to stop taking Trovan if they experience liver damage symptoms such as fatigue, yellowing skin or eyes, stomach pain with nausea or vomiting, or dark urine.
Last week, a consumer advocacy group urged that Trovan be banned in the United States, saying Americans can buy eight other equally effective but less risky antibiotics. The advocacy group Public Citizen repeated that recommendation Wednesday.
The FDA concluded, in a public health advisory to the nation's doctors, that Trovan no longer should be used for outpatient or less serious infections. But the agency said Trovan treats a slightly broader range of some of the most dangerous germs in hospitalized patients -- such as deadly abdominal infections -- and thus was important for emergencies.
Pfizer said even though it agreed to the restriction, other antibiotics have similarly dangerous risks. "We honestly don't believe Trovan needed to be restricted in this way," said vice president Dr. Joseph Feczko.
Written By Lauran Neergaard