Elidel Side Effects Cancer, Protopic Side Effects, Recall Lawsuit Due to Increased Risks of Skin Cancer

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SIDE EFFECTS OF ELIDEL & PROTOPIC

In February 2005, a FDA advisory panel said they were concerned the companies were aggressively advertising the medicines to treat infants and others with skin problems the creams which these creams were not approved to treat.Elidel, known generically as pimecrominum, and Protopic known generically as tacrolimus, should be used only as directed and only after other eczema treatments have failed to work because of the risk, the FDA said

ELIDEL & PROTOPIC LINKED TO SKIN CANCER & LYMPHOMA

Since the FDA approved Protopic in 2000 and Elidel in 2001, seven cases of lymphoma and six skin cancer cases have been reported in patients, the FDA said.Animal tests have suggested the creams could cause cancer, the FDA added.“The manufacturers of the products have agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent,” the FDA said.“Both products are applied to the skin to control eczema by suppressing the immune system. FDA’s Public Health Advisory specifically advises physicians to weigh the risks and benefits of these drugs in adults and children,” the agency added.

FDA REPORT-

PROTOPIC & ELIDEL INCREASED RISKS OF CANCER ESPECIALLY TO INFANTS

T05-06
March 10, 2005

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FDA Issues Public Health Advisory Informing Health Care Providers of Safety Concerns Associated with the Use of Two Eczema Drugs, Elidel and Protopic

The Food and Drug Administration (FDA) today advised health care professionals to prescribe Elidel (pimecrolimus) and Protopic (tacrolimus) only as directed and only after other eczema treatments have failed to work because of a potential cancer risk associated with their use. In addition, FDA is adding a black box warning to the health professional label for the two products and developing a Medication Guide for patients.

Today’s actions follow the recommendations made by the FDA’s Pediatric Advisory Committee during its February 15, 2005 meeting. At this meeting, findings of cancer in three different animal species were reviewed. The data showed that the risk of cancer increased as the amount of the drug given increased. The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic.

The manufacturers of the products have agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent. Both products are applied to the skin to control eczema by suppressing the immune system. FDA’s Public Health Advisory specifically advises physicians to weigh the risks and benefits of these drugs in adults and children and consider the following:

Elidel and Protopic are approved for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.
Elidel and Protopic are not approved for use in children younger than 2 years old. The long-term effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical trials, infants and children younger than 2 years of age treated with Elidel had a higher rate of upper respiratory infections than those treated with placebo cream.
Elidel and Protopic should be used only for short periods of time, not continuously. The long term safety of these products is unknown.
Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
Use the minimum amount of Elidel and Protopic needed to control the patient’s symptoms. The animal data suggest that the risk of cancer increases with increased exposure to Elidel or Protopic.

Protopic was approved in 2000 and Elidel in 2001 to treat eczema.

ELIDEL & PROTOPIC WARNINGS:

If you are currently using either Protopic or Elidel then you should talk to your doctor immediately about whether or not you are at increased risk for cancer due to other precipitating factors, including personal and family history of disease.

ELIDEL & PROTOPIC LAWSUITS

If you or a loved one have used Elidel or Protopic for eczema and you have been diagnosed with a skin cancer or have developed a lymphoma, then call us immediately to discuss what can be done to protect your legal rights. FREE CONFIDENTIAL CONSULTATION at 1-800-883-9858 or 1-800-468-4878 (Toll Free)