Submit your Defective Drugs claim details for a free, no obligation case review.
Get Started:
drug_recall protopicMarch 10, 2005
The FDA has issued a public health advisory to inform healthcare providers and patients of potential cancer risks from two popular eczema creams. Based on animal studies, case reports in a small number of patients and how the drugs work, the FDA said both Protopic and Elidel might carry a risk of cancer.
Although more studies are needed to determine the actual cancer risk present among human Protopic or Elidel users, the FDA has recommended the products be used only as second-line agents for short-term and intermittent treatment of eczema in patients unresponsive or intolerant of other treatments.
In addition, the drug agency has advised Protopic and Elidel never to be used in children younger than two years of age because the drugs’ effects on developing immune systems in infants and children is not known.
Approved in December 2000, the FDA has received reports of lymphoma and skin cancer in children and adults treated with Protopic, though the link between the product and reported cancers has not been clearly established. Protopic is applied to the skin to control eczema by suppressing the immune system.