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PROTOPIC OINTMENT TACROLIMUS LINKED TO CANCER IN CHILDREN:
The FDA has issued a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel (pimecrolimus) and Protopic (tacrolimus), products that are applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work.
Elidel and Protopic are often given to people for whom the potential side effects of topical corticosteroids (e.g., systemic absorption, skin thinning, telangiectasia) are a concern. However, the US Food and Drug Administration (FDA) recently reviewed the safety of these agents and warned that they may be associated with a risk of cancer.
BOXED WARNING FOR ELIDEL AND PROTOPIC On January 19, 2006, FDA approved new labeling for two Protopic Ointment also called tacrolimus. The new labeling includes a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling). The Medication Guide is to be distributed with each prescription to help ensure that patients using these prescription medicines are aware of this concern.
FDA NEW LABELING: The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.
If your child has been diagnosed with cancer after using Elidel Cream or Protopic Ointment, you should contact an attorney immediately. For a free case evaluation, fill out the form provided below:
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