According to a BMJ report, Astellas Pharma has lost its case against the journal Prescrire, which it sued for criticising its product Protopic® (tacrolimus ointment).

The September 2009 issue of the French edition of Prescrire featured a review of Protopic® in its newly approved indication of maintenance treatment for atopic eczema, to prevent flare-ups of the condition.  Following an analysis of the available data in 2003, the journal had concluded that tacrolimus should be avoided in atopic eczema, in view of its unfavourable risk-benefit ratio. The Prescrire review therefore tagged the product with an “unacceptable” label, the same label it had given it when previously reviewed in 2003.

Astellas claimed that Prescrire’s review had been “malicious” in its interpretation of the safety data of Protopic, and argued that the product’s licensed status automatically invalidated the journal’s views.  In its ruling the Paris Civil Court rejected the company’s lawsuit, stating that Prescrire’s review quoted three different types of risks linked with tacrolimus, “all of them documented and listed in the summary of product characteristics as established by the company Astellas Pharma itself.”