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Elidel

Pimecrolimus is an immunomodulating agent used in the treatment of atopic dermatitis (eczema). It is currently available as a topical cream, marketed by Novartis, under the trade name ElidelĀ®. more...

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In January, 2006, the United States Food and Drug Administration (FDA) announced that Elidel packaging would be required to carry a black box warning regarding the potential increased risk of lymph node or skin malignancy.

Pharmacology

Pimecrolimus is an ascomycin macrolactam derivative. It has been shown in vitro that pimecrolimus binds to macrophilin-12 and inhibits calcineurin. Thus pimecrolimus inhibits T-cell activation by inhibiting the synthesis and release of cytokines from T-cells. Pimecrolimus also prevents the release of inflammatory cytokines and mediators from mast cells.

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Other FDA advisories
From American Family Physician, 6/1/05

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.

COPYRIGHT 2005 American Academy of Family Physicians
COPYRIGHT 2005 Gale Group

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