- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Endocrinology, diabetology and metabolism and Neurology
New warnings and contraindications for ergot-derived dopamine agonists due to risk of fibrosis associated with chronic use.
Article date: October 2008
The European Medicines Agency (EMA) has recommended new warnings and contraindications for ergot-derived dopamine agonists as a result of the risk of fibrosis, particularly cardiac fibrosis, associated with chronic use. The risk of cardiac fibrosis is higher with cabergoline and pergolide than with the other ergot-derived dopamine agonists.
Cabergoline, pergolide, and bromocriptine are indicated for the treatment of Parkinson’s disease. Key advice on new warnings, contraindications, dose, and side-effects has previously been provided for this indication see drug safety update July 2008.
Cabergoline (brand leader Dostinex) is used in hyperprolactinaemia. The recommended initial Dostinex dose for this indication is 0·5 mg a week, given in 1 or 2 doses a week and titrated according to prolactin levels; therapeutic dose is usually 1 mg a week. Bromocriptine (brand leader Parlodel) is indicated for chronic endocrine disorders such as hyperprolactinaemia and acromegaly. For dosing information, refer to the summaries of product characteristics. This new advice applies only to treatment of chronic endocrine disorders with these agents—it does not apply to the inhibition of lactation.
Advice for healthcare professionals
Under advice for cabergoline and bromocriptine you should:
- exclude cardiac valvulopathy as determined by echocardiography before treatment
- monitor patients for signs or symptoms of pleuropulmonary disease (eg, dyspnoea, shortness of breath, persistent cough, or chest pain) and retroperitoneal disorders during treatment - renal insufficiency or ureteral or abdominal vascular obstruction might occur, with pain in the loin or flank and leg oedema: abdominal masses or tenderness could suggest retroperitoneal fibrosis
Under advice for cabergoline you should:
- monitor patients for signs of cardiac fibrosis during treatment
- echocardiography should be done within 3–6 months of starting treatment and subsequently at 6–12-month intervals
- stop treatment if echocardiography shows new or worsened valvular regurgitation, valvular restriction, or valve leaflet thickening
- exclude pregnancy before administration of cabergoline
- advise women who are planning pregnancy that they should stop taking cabergoline 1 month before they try to conceive
Article citation: Drug Safety Update Oct 2008, vol 2 issue 3: 2.