What is Elidel?
Elidel, also known by its generic name, Pimecrolimus, is an "immunomodulating agent" used in the treatment of dermatitis. It is marketed by Novartis. Elidel is in the form of a topical cream that is applied to the skin to treat cases of eczema. The FDA has issued a public health advisory about the possible risk of lymph node or skin cancer from its use, as well as similar drug Protopic.
Elidel Side Effects
The most common side effects of Elidel are a feeling of warmth or burning where the cream was applied, headache, cold-like symptoms such as stuffy nose, sore throat, and cough, and, infrequently, viral skin infection. It has also been cited by the FDA as a possible cancer risk.
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Elidel Black Box Warning
The FDA has issued a public health advisory to inform patients and healthcare providers about the possible risk of lymph node or skin cancer from use of Elidel. Animal studies, along with small numbers of case reports, indicate that Elidel may have a cancer risk. They have indicated that it may take human studies of 10 years or longer to confirm these reports. In the meantime, the FDA has advised that Elidel should only be used as labeled, and only in cases where other treatments have failed. The FDA announced that it was adding a "black box warning" to the labels on Elidel. Black box warnings are considered the strongest possible FDA warning.
Elidel And Cancer
The FDA advisory follows recommendations made by the FDA's Pediatric Advisory Committee during its mid-February meeting. At that meeting, the committee reviewed research that showed that the risk of cancer in three different species of animals increased along with increases in the doses of Elidel. The research material also included reports of cancers in children and adults treated with Elidel. In February, members of an FDA advisory panel said they were concerned with the aggressive advertisements for eczema creams to treat infants and others with skin problems the creams were not approved to treat. Babies should not be treated with the creams at all, the FDA said.
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Since the FDA approved Elidel in 2001, 54 serious injuries were reported in children under the age 2, as well as a eight cancers in all age groups. The majority of the noncancerous injuries were skin related, and ended with hospitalization for 15 children. The FDA recommends that doctors who prescribe the drugs remember they should be used only for the shortest time possible. "We made our recommendation based on animal data and biologic plausibility combined with the fact that the use of these products is increasing tremendously," says Dianne Murphy, MD, committee member and FDA director of the Office of Pediatric Therapeutics.
Questions and Consultations
If you or a family member has used the prescription drug Elidel and noticed adverse side effects, you should contact a physician immediately. If you would like to discuss your rights, are interested in more information on Elidel litigation, or if you have information about the cases that you would like to share with us, please click here to fill out a short evaluation form, and a member of Seeger Weiss LLP's experienced staff will call you to discuss your potential rights concerning Elidel. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.
Link To Lawyer Seek's Elidel Content:
<a href='http://www.lawyerseek.com/Practice/Pharmaceutical-Injury-C1/Elidel-P36/'>Elidel: Lawyer Seek</a> |
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