MINNEAPOLIS (CN) – A woman claims she got Hodgkin’s lymphoma from using Astella Pharma’s topical eczema drug, Protopic. She claims Astella knew of this danger in 2001, but failed to warn consumers.
Tanisha Denton claims she was diagnosed with Hodgkin’s lymphoma in April 2004. She claims Astella knew of the drug’s carcinogenic properties “no later than December 2001. … Indeed, the FDA expressed such a concern to Defendants in December 2001.”
Protopic, aka tacrolimus, is a calcineurin inhibitor. Denton claims that “On Oct. 30, 2003, an open meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee was held to discuss how to approach long-term monitoring for malignancy occurrence among patients treated for atopic dermatitis with tacrolimus and another calcineurin inhibitor,. The subcommittee noted that the preclinical and clinical studies of both pimecrolimus and tacrolimus suggested these drugs may increase the risk of malignancies in the pediatric population.”
She claims the FDA subcommittee met again in February 2005 to address the carcinogenic dangers of the drugs, and in March 2005 forced Astellas to put a “black box” warning on Protopic.
She demands damages for breach of warranty and failure to warn. She is represented by Gale Pearson with Pearson, Randall and Schumacher.