Public Statement on Sifrol, Daquiran, Mirapexin (Pramipexole) - Recommendation to Reinforce the Warningon the sudden onset of sleep
News
The European Commission granted marketing authorisations for the European Union to Boehringer Ingelheim International GmbH on 14 October 1997 for Sifrol®, to Dr. Karl Thomae GmbH on 27 October 1997 for Daquiran® and to Pharmacia & Upjohn S.A. on 23 February 1998 for Mirapexin®.
Pramipexole is one of the currently available dopaminergic agonists authorised in the European Union for the treatment of signs and symptoms of advanced idiopathic Parkinson's disease in combination with levodopa. Pramipexole is available as 0.088 mg, 0.18 mg, 0.7 mg and 1.1 mg tablets.
Following reports of potentially unpredictable, life threatening, episodes of sudden onset of sleep with pramipexole administration, changes to the Summary of Product Characteristics and Package Leaflet of pramipexole were introduced through an Urgent Safety Restriction procedure on 15 July 1999. Information was released in a Public Statement (EMEA/20642/99) by the EMEA on 19 July 1999.
A total of 20 cases of sudden onset of sleep have now been reported in the USA. Fourteen of these occurred while patients were driving resulting in 9 car accidents with minor injuries in some cases.
In a follow-up to the Urgent Safety Restriction procedures, the CPMP carried out a more comprehensive evaluation of this issue at their plenary meeting on 27-29 July 1999 including an oral presentation from the Marketing Authorisation Holders. A further strengthening of the wording in the Summary of Product Characteristics and Package Leaflet was agreed with the Marketing Authorisation Holders:
- Patients being treated with pramipexole must be informed not to drive or engage in other activities where impaired alertness could put themselves or others at risk of serious injury or death (e.g. operating machines).
In addition, information about the dose dependency of the somnolence was included in the Summary of Product Characteristics:
- The incidence of somnolence is increased at doses higher than 1.5 mg/day (salt) The CPMP adopted revised Summary of Product Characteristics and Package Leaflets (see attachment) through Type II variations on 29 July 1999.
Pramipexole containing medicinal products were first launched in the European Union in June 1998 and are currently marketed as Mirapexin® in Greece, Italy, Spain and United Kingdom and as Sifrol® in Denmark, Finland, Germany, the Netherlands and Sweden. Daquiran® has not yet been launched in the European Union.