Article date: July 2008
The European Medicines Agency has recommended new warnings and contraindications for ergot-derived dopamine agonists as a result of the risk of fibrosis associated with chronic use. Verify that patients do not have cardiac fibrosis before starting treatment of ergots. Monitor patients for signs of fibrosis during treatment with blood tests, echocardiography, or chest radiography as appropriate. Prescribe ergots according to the updated prescribing information (below).
Ergots are mainly used to treat Parkinson’s disease. Although fibrosis is a known side-effect of ergots, the Agency’s Committee for Medicinal Products for Human Use reviewed new data for an increased risk of fibrosis, particularly cardiac fibrosis, in patients who received ergots as chronic treatment, suggesting that fibrosis can develop before occurrence of symptoms.
The risk of fibrosis is not equally established for all ergots. Pergolide, cabergoline, and bromocriptine are ergots licensed for treatment of Parkinson’s disease in the UK. Their product information will be updated and includes:
- cabergoline and pergolide: prescribing information currently has a contraindication for patients with evidence of valve problems and a restriction to second-line use Parkinson’s disease
- a warning that patients must be monitored for signs of fibrosis on echocardiography before treatment is started and regularly during treatment
- a reduction of maximum recommended dose to 3 mg a day
- inclusion of cardiac fibrosis as a very common side-effect
- a contraindication for patients with pre-existing valve problems
- restriction of maximum dose to 30 mg a day
Advice for healthcare professionals includes:
- prescribe ergots according to the updated prescribing information (above)
- ergots should not be given to patients who have had fibrosis in the heart, lungs, or abdomen. Absence of cardiac fibrosis should be verified before treatment is started
- monitor patients for signs of fibrosis during treatment by use of blood tests, echocardiography, or chest radiography as appropriate
Article citation: Drug Safety Update July 2008; Vol 1, Issue 12: 9