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Trovan

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Trovan is an antibiotic manufactured by Pfizer Pharmaceuticals and approved by the Food and Drug Administration (FDA) in 1997. The drug, whose generic name is Trovafloxacin, is used to treat many bacterial infections including, but not limited to sinusitis (sinus infection), sexually transmitted disease (STDs), pneumonia, urniary tract infection, severe strep throat, bronchitis, and chronic obstructive pulmonary disease In June 1999 the FDA dramatically reduced the permitted uses of Trovan after numerous reports surfaced regarding the drug's damaging affect on the liver, including its propensity to induce fatal liver failure. Today, Trovan is used as a drug of last resort, given only to those patients who are on the verge of death and have not responded successfully to other antibiotic treatments.

It is estimated that 2.5 million prescriptions have been written for

Trovan, a quinolone antibiotic, since its February 1998 market launch in oral and intravenous formulations. Trovan was initially approved for treating a broad range of infections, from minor skin infections to severe infections in hospitalized patients.

In July 1998, FDA worked with the manufacturer to strengthen the product's labeling concerning liver problems after receiving reports of elevated liver enzymes and symptomatic hepatitis in patients after short- and long-term therapy. Since then, FDA has continued to receive reports of liver toxicity, including reports of a more serious nature.

FDA is now aware of 14 cases of acute liver failure that it has concluded are strongly associated with the drug. Six of these patients died: five due to liver failure and one of four additional patients who received liver transplants. Three patients recovered without requiring liver transplants, and for the remaining two patients the final outcome is still pending.

 

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