Other FDA advisories

Date: June 1, 2005

Other FDA Advisories:

Recall of urine processing kit. The U.S. Food and Drug Administration (FDA) has issued a Class I recall of the ProbeTec ET Urine Processing Kit, which screens for Chlamydia and gonorrhea. Because the kit may cause false-negative results, the FDA is concerned that some patients might not receive treatment. If left untreated, these infections can worsen or cause further disease transmission and complications in pregnant patients.

Combination therapy may cause hepatitis. Studies have found that healthy volunteers could contract drug-induced hepatitis with marked transaminase elevations after taking simultaneous regimens of rifampin (Rifadin) and ritonavir (Norvir)-boosted saquinavir (Fortovase). The drug's manufacturer recommends that physicians not prescribe rifampin for patients taking ritonavir-boosted saquinavir. The combination regimen is used as an antiretroviral therapy for human immunodeficiency virus infection.

Warning labels ordered for two eczema medications. The FDA has announced that it will require warning labels for pimecrolimus (Elidel) and tacrolimus (Protopic), topical creams used to manage eczema. Recent studies on animals and limited case studies on humans have found an increased cancer risk associated with the two medications. Although more studies are needed, the FDA recommends that physicians prescribe these medications only as a second-line, short-term therapy for patients unresponsive to other treatments. The FDA also advises physicians to avoid prescribing them to children younger than two years and to persons with weakened immune systems.

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