FDA has put another Boehringer Ingelheim drug under its safety microscope. The agency said the Parkinson's disease treatment Mirapex may be linked to an increased risk of heart failure, and it's working with Boehringer to clarify that risk.
The agency's safety communication cites several studies that suggested an increased risk of heart failure among patients using Mirapex, not only compared with drugs in other classes, but within its class of dopamine agonists. A recently published study, for instance, found an increased risk for heart failure with Mirapex compared with another Parkinson's treatment, levodopa; other dopamine agonists didn't appear to be associated with a similar increase in risk, the agency said.
But the data "had a number of limitations," FDA pointed out, including an imbalance in the percentage of patients with cardiovascular risk factors. "FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex," the agency said.
Mirapex went off patent in 2010, but Boehringer sells an extended-release version that's still available only in branded form. The drug brought in 668 million euros last year (about $865 million at today's exchange rate), down 20% year over year. Its newer drug, Pradaxa, a blood thinner, is also under safety review by FDA after reports of severe bleeding, including hundreds of fatal cases.
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