On Dec. 19 the U.S. Food and Drug Administration announced the forthcoming discontinuation of all dosage strengths of ropinirole hydrochloride (Requip) tablets as well as the 2-mg extended release (Requip XL) tablets. The anticipated final date of availability to patients will be between January and May 2019, depending on the tablet strength. The discontinuation announcement does not apply to the 4-mg, 6-mg, 8-mg and 12-mg tablets of Requip XL.
Ropinirole is a dopamine agonist that is indicated for the treatment of Parkinson’s disease and restless legs syndrome (RLS). AASM practice parameters for the treatment of RLS and periodic limb movement disorder in adults include the standard recommendation that clinicians should treat patients with RLS with ropinirole, with the benefits of treatment clearly outweighing the harms. Another standard recommendation supports the use of pramipexole to treat RLS.
The FDA announcement indicates that the discontinuation of ropinirole tablets is due to a “business decision” made by pharmaceutical manufacturer GlaxoSmithKline.
Read more AASM practice guidelines.
GSK to discontinue RLS treatment ropinirole, maintain extended release tablets
Source: Sleep Study News