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FDA Advises on Cancer Risks of Elidel and Protopic

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Submitted by Armen Hareyan on 2005, March 12 - 14:23

Hickory, NC - A potential cancer risk is associated with the increased use of Elidel (pimecrolimus and Protopic (tacrolimus) and the health care professionals are advised by The Food and Drug Administration (FDA) to prescribe these two drugs only as directed and only after other eczema treatments have failed to work. Both drugs suppress the immune system by applying them on the skin to control eczema.

FDA took this action following the recommendations made by the FDA's Pediatric Advisory Committee during its February 15, 2005 meeting, after reviewing the findings of cancer in three different animal species.

As the amount of the given drug increased the risk of the cancer increased in parallel, the data showed. There is also a report of small number of cancers in children and adults that were treated with Protopic or Elidel.

In order to determine the extent of the actual possible risk of cancer in humans the producers of these prescription drugs have agreed to conduct further research to support the findings of the data.

In the meanwhile the FDA advises the doctors and the health care professionals to consider the associated risks and the side effects of these drugs with their benefits.

According to the Advisory Protopic and Elidel are approved for short-term use in patients who are either intolerant of unresponsive of other ways of treating atopic dermatitis (eczema). These drugs are not approved for children younger than 2 years old. The long term safety of these drugs are unknown. These drugs should not be used if the patient's immune system is compromised. Only the minimum amount should be used, just enough to control the symptoms, since the animal data showed that the increased use of Elidel and Protopic increases the risks of cancer.

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Copyright 2005 eMaxHealth.com

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