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# Petition Asks Warnings for RLS Drugs
- URL: https://www.fdaweb.com/petition-asks-warnings-for-rls-drugs/
- Published: 2017-06-14T12:00:00.000Z
- Updated: 2026-09-14T22:29:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138933

BioMedEcon is asking FDA to require labeling changes for manufacturers of dopamine agonists used to treat restless leg syndrome including risks of serious mental disorder reactions. The [petition](ttps://www.regulations.gov/document?D=FDA-2017-P-3486-0001) specifically cites Mirapex (pramipexole), Requip (ropinirole HCl), and Neupro (rotigotine). The agency is asked to: 

- require addition of a Boxed Warning to the three products advising of the risk for development of new onset and exacerbation of existing mental disorders;
- require that manufacturers of the three products amend current product labeling to provide specific amplification of the risk to restless leg syndrome patients for adverse mental disorder reactions;
- require manufacturers of the three drugs to revise the current Medication Guide to more appropriately reflect the risk of serious adverse mental disorder events induced by dopamine agonist treatment for restless leg syndrome; and
- require the manufacturers to issue and disseminate Dear Healthcare Provider drug warning letters apprising them of the labeling changes.