Drug Safety Update: A Promising New Monthly Electronic Bulletin From The UK's Drug Agency

First Issue Includes Updated Advice Regarding Dostinex; Now A Second-Line Treatment Due To Increased Risk Of Serious Heart Valve Damage

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the United Kingdom (UK) the Medicines and Healthcare products Regulatory Agency (MHRA), and its independent advisor the Commission on Human Medicines (CHM), have replaced Current Problems in Pharmacovigilance, which was previously sent in hard copy to certain healthcare professionals, with a new monthly electronic bulletin called Drug Safety Update.  According to an introduction in its first issue, this bulletin is intended to provide useful information for a wide range of healthcare professionals, such as doctors, pharmacists, nurses, and dentists.

The first issue of Drug Safety Update, August 2007, included a short but informative piece with current advice about prescribing Dostinex (cabergoline). 

As background, Dostinex and Permax (pergolide) are ergotamine dopamine agonists that have been associated with cardiovalvulopathy and other fibrotic adverse drug reactions.  As reported previously, studies done in 2006 and 2007 put the spotlight on serious cardiac side effects associated with Dostinex and Permax.  These studies ultimately led to Permax being withdrawn from the U.S. market in March 2007.

The August 2007 Drug Safety Update article about Dostinex sets forth this updated prescribing advice from a so-called "Dear Doctor" letter about Dostinex (known as Cabaser in the UK) sent during April 2007:

• The indication for cabergoline has been restricted to second-line treatment in
  patients who are intolerant, or do not respond, to treatment with a non-ergot
  compound. Cabergoline can be given in this restricted setting as monotherapy or
  as an adjunct to levodopa plus dopa-carboxylase inhibitor
• Cabergoline is contraindicated in patients with a history of pulmonary, pericardial,
  or retroperitoneal fibrotic disorders, or in those with anatomic evidence of
  cardiovalvulopathy
• Monitoring for development of valvular disease or fibrosis is recommended.
  Echocardiography should be done within 3–6 months of starting treatment, and
  should be done at least every 6–12 months thereafter

Based on this first issue, we will look forward to receiving the new Drug Safety Update bulletin from the MHRA each month, hopefully for many years to come.