February 15, 2005 by TP Admin
Posted in
FDA ALERT [2/14/2005]: FDA is investigating postmarketing reports of lymphoma and skin cancer in children and adults treated with Protopic, but a causal relationship has not been established. We are continuing to analyze these reports to determine whether the occurrence of these adverse events affects the risk/benefit assessment of Protopic therapy. Protopic is not approved for use in pediatric patients less than 2 years of age.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
More information is available at FDA Alert - Protopic
