Drugs Xagena
Eli Lilly has informed Healthcare Professionals of important safety information and changes to the prescribing information for Celance ( Pergolide ) prompted by reports of fibrotic reactions, including valvulopathy, in chronic users of ergot-derived dopamine receptor agonists. These changes have been agreed to by the Committee for Medicinal Products for Human Use ( CHMP ) during an EU referral procedure which reassessed the risk profile of ergot-derived dopamine receptor agonists.
Recent data from published literature suggest that higher doses and/or cumulative exposure of ergot-derived dopamine receptor agonists are risk factors for development of valvular pathology. Based on these findings, the Posology, Contraindications, Warnings and Undesirable Effects sections of the Summary of Product Characteristics have been modified.
Changes to the Summary of Product Characteristics
The following points highlight the changes:
The maximum dose of Pergolide has been reduced from 5 mg per day to 3 mg per day.
Before initiating treatment, all patients must undergo a cardiovascular evaluation, including echocardiogram.
Evidence of cardiac valvulopathy, as determined by pre-treatment echocardiography, is a contraindication.
Clinical diagnostic monitoring for development of valvular disease or fibrosis, as appropriate, is now considered essential rather than recommended. Following treatment initiation, the first echocardiogram must occur within 3-6 months; thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment but must occur at least every 6 to 12 months.
Cardiac valvulopathy ( including regurgitation ) and related cardiac disorders ( pericarditis and pericardial effusion ) are listed as very common undesirable effects.
Source: Medicines and Healthcare product Regulatory Agency MHRA, 2008
XagenaMedicine_2008
