Parkinson's Disease Drug Permax Ordered Off The Market By Health Canada

Permax Was Voluntarily Withdrawn From the U.S. Market Earlier This Year At The Insistence of FDA

(Posted by Tom Lamb at DrugInjuryWatch.com)

As you may recall, the Parkinson disease drug Permax was voluntarily withdrawn from the U.S. market in late March 2007 after studies in the New England Journal of Medicine underscored the increased risk of serious heart valve damage associated with Permax.

In Canada, however, Eli Lilly Canada Inc. had continued to sell Permax (pergolide). 

On August 16, 2007, however, Health Canada announced the sales of Permax must cease in their country as of August 30, 2007

In more detail, from a MedEffect Public Communication about Permax issued on August 16, 2007, we get this information about why Health Canada has taken this action:

• Two studies published in the New England Journal of Medicine (NEJM) in January 2007 showed that patients with Parkinson's disease who were treated with Permax had an increased chance of serious heart valve damage when compared to patients who did not receive the drug. [footnotes omitted] In light of this recent information, Health Canada has determined that there is not enough evidence to support the continued safe use of Permax as currently recommended in the prescribing information.
• Eli Lilly Canada Inc., in co-operation with Health Canada, will stop sales of Permax (pergolide mesylate) in Canada as of August 30, 2007 due to the potential for cardiac valvulopathy, a condition involving inflammation or stiffening of the heart valves. Pharmacies may continue to sell Permax after that date to allow patients sufficient time to consult with their healthcare providers and to transition to an alternative medication.

Eli Lilly Canada Inc. has sent a so-called "Dear Doctor" letter to Canadian healthcare providers about Permax informing them that sales of this Parkinson's disease drug will stop in Canada as of August 30.  This Permax Dear Doctor letter also gives advice for discontinuation and transition to alternative medications for Canadian patients currently taking Permax.