Two consumer-directed pharmacy printouts and a professionally directed labeling piece for Boehringer-Ingelheim's Mirapex were considered misleading, according to a warning letter from FDA's DDMAC.
The letter said the consumer printouts presented Mirapex efficacy claims but failed to either communicate any risk information or to communicate the most important risks associated with Mirapex use. Also, the DDMAC wrote, it appeared that neither piece was accompanied by the FDA-approved product labeling. The professional piece presented efficacy claims but omitted material facts and broadened the drug's indication, according to the warning letter. DDMAC said the materials raised significant public health and safety concerns by suggesting that Mirapex is safer than has been demonstrated.
Mirapex's labeling said it is indicated for treating moderate-to-severe primary restless leg syndrome (RLS). The labeling lists warnings, including falling asleep during activities of daily living, symptomatic hypotension and hallucinations.
The DDMAC letter described numerous efficacy claims in the consumer printouts. It said one of the printouts failed to present any risk information and the second failed to reveal important warnings. The DDMAC said a statement at the bottom of the two printouts telling consumers to see accompanying information was not sufficient. The professionally directed piece failed to present the approved Mirapex indication.