Drugs Xagena
The Healthcare Professionals have been informed about new safety information regarding the occurrence of cardiac valvulopathy / fibrotic disorders for the following medicines:
Cabaser ( Cabergoline tablets, uncoated: 1 mg, 2 mg and 4 mg ) indicated for the treatment of Parkinsons disease;
Dostinex ( Cabergoline tablets, 0.5mg ) indicated for the treatment of hyperprolactinaemic disorders and the inhibition/suppression of physiological lactation.
Treatment with Cabergoline ( Cabaser and Dostinex ) has been associated with the onset of fibrotic cardiac valvulopathy.
The Summary of Product Characteristics ( SPC ) for Cabaser in the treatment of Parkinsons disease and Dostinex in the treatment of hyperprolactinaemic disorders will be updated as follows:
Cabaser
Restriction of the maximum recommended dose to 3 mg/day in the treatment of Parkinsons disease;
Contraindication in patients with a history of fibrotic disorders and evidence of cardiac valvulopathy as determined by pre-treatment echocardiography;
Warnings including mandatory echocardiographic monitoring before initiating treatment and regularly during treatment, and clinical monitoring of other fibrotic events;
Undesirable effects to include cardiac valvulopathy and related disorders ( pericarditis and pericardial effusion ) as very common side-effects.
In line with the Committee for Medicinal Products for Human Use ( CHMP ) conclusion, Pharmacia Laboratories will discontinue the production and distribution of the
Cabaser 4mg tablets for the European Union from 31st October 2008.
Dostinex
Contraindication in patients with a history of fibrotic disorders and evidence of cardiac valvulopathy as determined by pre-treatment echocardiography:
Warnings including mandatory echocardiography monitoring before initiating treatment and regularly during treatment and clinical monitoring of other fibrotic events;
Undesirable effects to include cardiac valvulopathy and related disorders ( pericarditis and pericardial effusion ) as very common side-effects;
The recommended initial dose remains 0.5 mg per week given in one or two doses per week and titrated according to prolactin levels. The therapeutic dose is usually 1 mg per week.
Prescribers are reminded that pregnancy should be excluded before administration of Dostinex. Women seeking pregnancy should discontinue Dostinex at least one month before intended conception.
Further information
On 21 June 2007 the European Medicines Agency ( EMEA ) initiated a safety review of ergot-derived dopamine agonists, including Cabergoline.
The safety review arose from published articles that reported an increased risk of fibrotic disorders and cardiac valvulopathy in patients treated for Parkinsons disease with ergot dopamine agonists, including Cabergoline.
Cabergoline is already restricted to second-line therapy for the treatment of Parkinsons disease, and the SPC includes the contraindication anatomical evidence of cardiac valvulopathy of any valve.
The CHMP concluded that the following sections of the SPC were to be amended: contraindications; special warnings and precautions for use; and undesirable effects.
Source: Medicines and Healthcare product Regulatory Agency MHRA, 2008
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