Eczema drug Protopic may cause cancer
The US Food and Drug Administration (FDA) today advised health care professionals to prescribe 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 Protopic and developing a Medication Guide for patients. Protopic was approved in 2000. Similar action is also being taken against another drug Elidel.
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 Protopic.
The manufacturers of Protopic, Fujisawa Healthcare, has agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent. No recall of Protopic is being mentioned at this time either by the FDA or Fujisawa Healthcare. Protopic is 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 Protopic in adults and children and consider the following:
- Protopic is approved for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.
- Protopic is not approved for use in children younger than 2 years old. The long-term effect of Protopic on the developing immune system in infants and children is not known.
- 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 Protopic.
- Use the minimum amount of Protopic needed to control the patient’s symptoms. The animal data suggest that the risk of cancer increases with increased exposure to Protopic.
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