Restless Legs Drugs Need Black Box Warnings, FDA Hears

Posted by Sarah Showard | Jun 16, 2017 | 0 Comments

Law360, New York (June 15, 2017, 7:03 PM EDT) By Jeff Overley

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 has had no influence over any of our research methods, results or any other aspect of the content provided” in the petition, BioMedEcon wrote.

The same dopamine agonists are the subject of a pending citizen petition submitted by consumer group Public Citizen, which also warned that the drugs can cause extreme desires for sex, eating, shopping and gambling. The FDA last year slapped such a warning on Abilify, a partial dopamine agonist.

BioMedEcon's petition requested four actions. First, it asked for black box warnings on the three drugs regarding the potential development and exacerbation of mental disorders, including impulse-control disorders, schizophrenia, addiction and obsessive compulsive disorder.

Second, the petition requested that labels emphasize that risks of mental disorders apply to RLS patients. According to BioMedEcon, current labeling discloses such risks, but does so in a way that emphasizes the risks to patients with Parkinson's disease, which the dopamine agonists also treat.

“This imbalance leaves the erroneous impression that patients with RLS are protected from these risks,” the citizen petition said.

In a third request, BioMedEcon said that the product labels should revise medication guides to reflect the risks of mental disorders. And in a fourth request, BioMedEcon said that the risks should be communicated to doctors via “Dear Health Care Provider” letters.

Numerous companies sell versions of the three dopamine agonists.

An FDA spokeswoman had no comment Thursday, saying only that the agency will respond to the petition.

Horizant was previously sold by GlaxoSmithKline PLC, but the company sold off the product rights amid disappointing sales, according to published reports.

--Additional reporting by Adam Lidgett and Brian Amaral. Editing by Alyssa Miller.

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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