Sinus Drug causes skin problems

Eddie Farah
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Posted by Eddie FarahSeptember 11, 2006 8:09 PM

Federal Health officials report an antibiotic manufactured by Oscient Pharmaceuticals Corp needs further studies because of serious skin reactions associated with its use.

The FDA advises when compaire with other antibiotics used in treatment of minor infections, the incidents of serious rashs has them concerned how safe this drug is.

The FDA approved Factive in 2003 to treat pneumonia and bronchitis. The manufacturer is now seeking approval for treatment of acute bacterial sinusitis. The FDA declined to approve this drug for that use in 2002.

Real-world use of Factive has shown what clinical trials previously revealed: The risk of rashes associated with the antibiotic appears to be greater when compared with that seen in other, similar antibiotics, according to the FDA.

The FDA will seek advice of the anti-invective drug advisory committee whether the benefits of Factive outweigh the risks. Some members of the FDA already believe further study is necessary, especially given the risk of skin reactions associated with the drug.

The magnitude of the benefit gained from the use of gemifloxacin (Factive) to treat acute bacterial sinusitis, needs to be clearly defined to weigh the magnitude of this drug-related risk.

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