Elidel and Protopic to Carry the FDA's Strongest 'Black Box' Warning
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March 10, 2005 -- The FDA is warning doctors to prescribe two popular eczema treatments with caution after concerns over a possible cancer risk associated with their use.
The two creams, Elidel and Protopic, will also soon carry the FDA's strongest "black box" warning on their packaging to alert doctors and patients to these potential risks. The warning advises doctors to prescribe short-term use of Elidel and Protopic only after other available eczema treatments have failed in adults and children over the age of 2.
At a meeting last month, the FDA's Pediatric Advisory Committee reviewed research in animals that linked Elidel and Protopic to an increased risklinked Elidel and Protopic to an increased risk of skin cancer and non-Hodgkin's lymphoma. In those studies, the risk of cancer increased as the dose of the drugs increased.
Research presented at the meeting also linked Elidel and Protopic to about 25 cases of cancer in adults and children who used the drugs.
The FDA has also received reports of serious adverse events in children under the age of 2 who were prescribed the drugs, although they have not been approved for use in children in this age group.
Elidel was approved in 2001 and Protopic in 2000 to treat adult eczema,eczema, which is an inflammatory condition of the skin affecting about 15 million Americans, 20% of whom are children. The condition causes dry, red, itchy skin that can blister or develop scaly patches.
Since their approval, the FDA estimates that more than 12 million prescriptions have been written for Elidel and Protopic. Both drugs are applied to the skin to control eczema by suppressing the immune system and are viewed as an alternative to the steroid-based drugs cuwrrently used to treat eczema.
The FDA says manufacturers of Elidel and Protopic have agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent.
The FDA's warning advises doctors to weigh the risks and benefits of these drugs in adults and children and to consider the following:
Elidel and Protopic are approved for short-term and intermittent eczema treatment in people who have not responded to or are intolerant of other eczema 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 a 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 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 show that the risk of cancer increases with increased exposure to Elidel or Protopic.