Elidel Side Effects Injury Lawsuits. Elidel, manufactured by Novartis, was approved by the FDA in December 2001. Elidel is prescribed to treat Eczema and is also commonly prescribed off-label for psoriasis and dermatitis seborrhea.
On March 10, 2005, the FDA stated that Elidel should carry a strong advisory about cancer risks. Research shows that the cream is absorbed into the body and may have the potential to cause cancer. The FDA is working on a Prime black box Prime; warning for Elidel. The data collected by the FDA showed that the risk of cancer increased as the amount of the drug given increased. This data also included a small number of reports of cancers in children and adults treated with Elidel. Elidel and similar medications suppress the immune system, which may be a precipitating factor in the development of cancer. Elidel has become widely prescribed as an alternative to steroid creams, which also have long-term side effects.
Elidel Must Bear Black Box Warnings of Possible Cancer Risks
On January 20, 2005, the FDA declared that Elidel must bear black box warnings of possible cancer risks. The new labeling will also recommend that the drug be prescribed for use only after other prescription topical medicines have been tried by patients. The FDA is also issuing a guide updating patients of its concerns. A black box warning is the most serious type of warning in prescription drug labeling. The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk. As of October, the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with both Elidel or Protopic, said Dr. Stanka Kukich, the acting director of the FDA’s dermatological and dental drug products division.