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...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!