New Warning About Dostinex Side Effect Fibrotic Cardiac Valvulopathy In U.K.

September 2008 Dear Doctor Letter From Pfizer Follows 2007 EMEA Safety Review Of Cabergoline

(Posted by Tom Lamb at DrugInjuryWatch.com)

Pfizer's Dostinex (cabergoline) remains on the market despite the January 2007 reports in the New England Journal of Medicine that Dostinex, like Permax, was linked to valvular heart disease.

In June 2007 the European Medicines Agency (EMEA) initiated a safety review of ergot-derived dopamine agonists, including cabergoline, which is sold in Europe under the brand name Cabaser as well as Dostinex.

More recently, in September 2008 the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) brought renewed attention to the association between Dostinex / Cabaser and fibrotic cardiac valvulopathy when the agency posted online the item "Information sent to healthcare professionals in September 2008 about the safety of medicines". 

Therein was listed the so-called "Dear Doctor" letter about Dostinex and Cabaser which Pfizer Ltd. sent out in the U.K. on or about September 15, 2008.  From the Dostinex section of that Septmeber 2008 Dear Doctor letter we get these warnings:

Dostinex—treatment of hyperprolactinaemic disorders

• Contraindication in patients with a history of fibrotic disorders and evidence of cardiacvalvulopathy 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.

We will let you know when any similar "Dear Doctor" letter about Dostinex is sent by Pfizer in the U.S.  If somehow we missed that corresponding Dostinex letter, here, and you have a copy of it, please let us know.