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WARNING: Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Ointment linked to Cancer
The FDA has issuing 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. Animal studies have shown that three different species of animals developed cancer following exposure to these drugs applied topically or given by mouth, including mice, rats and a recent study of monkeys. These studies were conducted at doses higher than generally used by patients and the risk of cancer increased with increasing drug dose and duration
The FDA recomends Elidel and Protopic should not be used in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream.
- Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel and Protopic are unknown.
- Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
In addition to an ointment, tacrolimus, also comes as a pill or by injection, this form is known as (Prograf). Prograf is approved to prevent liver or kidney transplant rejection. It is known to cause both skin cancers and lymphoma in humans by suppressing the body’s normal immune defenses against cancer. The cancer risk increases with higher doses and longer treatment courses of Prograf. Both Elidel and Protopic are sometimes absorbed through the skin, though usually at very low amounts. Occasionally, children who have been treated with Elidel or Protopic have had high blood levels of these drugs.
Protopic was approved in December 2000 and Elidel in December 2001. Since their approval, FDA has received reports of lymphoma and skin cancer in children and adults treated with Elidel or Protopic; whether the reported cancers are associated with these products has not been clearly established.
If your child has suffered from cancer or lymphoma after using Protopic or Pimecrolimus Elidel cream, you should contact an attorney immediately. For a free case evaluation, fill out the form below:
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