Restless Legs Drugs Need Black Box Warnings, FDA Hears
By Jeff Overley (June 15, 2017, 7:03 PM EDT) -- Several drugs for restless legs syndrome should get black box warnings that emphasize the risks of impulse-control disorders and other side effects, an industry-backed research company told the U.S. Food and Drug Administration in a petition released Wednesday.
The citizen petition from California-based BioMedEcon LLC urged tougher warning labels for three dopamine agonist drugs — pramipexole, ropinirole and rotigotine — that treat RLS. In its petition, BioMedEcon said that it found understated risks during research for Arbor Pharmaceuticals, which sells a competing RLS drug called Horizant that is not a dopamine agonist.
"Although our research is funded by Arbor, this sponsor...
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