Drug Warning: Protopic Side Effects and Risks
The eczema drug Protopic, manufactured by Astellas Pharma, Inc. (formerly Fujisawa Healthcare), has been linked to cancer according to the FDA (Federal Food and Drug Administration). Protopic treats eczema by suppressing the immune system, and this may make the people who use it more susceptible to cancer, particularly skin cancer.
On January 19, 2006 the FDA issued a notice that Astellas Pharma, the manufacturer of Protopic, to include a black box warning on the Protopic package. This is the highest level of waning the FDA can require. The warning contains many of the recommendations made by the FDA in a March 2005 alert. In that warning the FDA recommended that health care providers and patients:
- Use Protopic and another eczema drug, Elidel, only as second-line agents for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of, other treatments.
- Avoid the use of Protopic and Elidel in children younger than 2 years of age. The effect of Protopic and Elidel 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 Protopic had a higher rate of upper respiratory infections than did those treated with placebo cream.
- Use Protopic and Elidel only for short periods of time, not continuously. The long-term safety of Protopic and Elidel are not known.
- Children and adults with a weakened or compromised immune system should not use Protopic or Elidel.
- Use the minimum amount of Protopic or Elidel needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer.
Check out the following articles for more information about Protopic, filing a Protopic lawsuit and finding a Protopic attorney:
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