United Kingdom. The Committee on Safety of Medicines has recently reviewed the safety profile of the fixed-dose combination product, tranylcypromine/trifluoroperazine (Parstelin: SmithKline Beecham), in order to decide whether to renew the licence for this product and concluded that the continued availability of tranylcypromine/trifluoroperazine is no longer appropriate, because of concerns over drug interactions and the risk of severe hypertensive crises. The Committee recommended that the licence should not be renewed. As a result, the company will withdraw the product from the UK market.
All patients currently treated with Parstelin should be assessed and have Parstelin withdrawn over the next few months. An appropriate “washout period” of at least two weeks should be instituted for patients who need to be transferred to treatment with an alternative antidepressant (unless transferring to tranylcypromine alone).
Reference: Current Problems in Pharmacovigilance Vol. 25, June 1999.