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Quote.com News Item #10316896
Headline: Group Seeks Ban of Antibiotic Trovan
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By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) - The popular antibiotic Trovan is too dangerous
to stay on the market, a consumer advocacy group contended in a
petition filed Thursday that accuses the government of approving
the drug despite evidence it could harm patients' livers.
Since February 1998, 140 cases of serious liver damage have been
reported among Trovan users. While most recovered after stopping
the antibiotic, five patients died and three required liver
transplants.
Americans can buy eight other antibiotics from the same drug
class, called quinolones, that are equally effective but less
dangerous to the liver, said Dr. Sidney Wolfe of the consumer
advocacy group Public Citizen, which petitioned the Food and Drug
Administration on Thursday to ban Trovan.
Wolfe cited an internal FDA report that concluded almost a year
ago that Trovan was more liver-toxic than related antibiotics.
''Trovan is another example of a drug with no unique benefits
and unquestionably unique, life-threatening risks,'' said Wolfe,
who has long charged that the FDA approves too many ''me-too''
drugs that are no better than competitors but turn out to be
riskier.
The European Union last week warned Europeans to stop taking
Trovan if they experience symptoms suggesting liver damage.
Officials did, however, call the risk rare, since Trovan has been
prescribed to 2.5 million people.
At the time, the FDA called the liver problems serious and said
it was discussing them with manufacturer Pfizer Inc. But the FDA
has not yet upgraded warnings for Americans.
Spokesman Lawrence Bachorik said the FDA said would consider
Wolfe's petition carefully. ''We're concerned about the adverse
events associated with this product, and we're discussing them with
the company,'' he said.
Pfizer declined comment.
Before Trovan's approval, animal studies suggested the drug
could harm liver cells. Also, a study of 140 men who took Trovan
for inflamed prostates found 10 percent had liver tests suggesting
damage, Wolfe said. That's a high side-effect rate, and the study
showed the damage was most likely when people took the drug longer
than two weeks, he said.
Every drug causes side effects, and the FDA often approves drugs
with liver risks as long as doctors are warned to monitor patients
carefully so they can stop the drug if a problem arises. Trovan's
label tells doctors that monitoring patients' livers is advisable,
but Wolfe said that's not enough.
Symptoms of liver toxicity include fatigue, yellowing of the
skin or eyes, stomach pain with nausea or vomiting, or dark urine. |
