Cease Sale of PERMAX^® (pergolide mesylate) in Canada as of August 30, 2007 - Eli Lilly Canada Inc.

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
 
This is duplicated text of a letter from Eli Lilly Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Mandated Important Safety Information on
Permax^® (pergolide mesylate)

August 16, 2007

Subject: Manufacturer Sales of Permax^® (pergolide mesylate) Will Stop in Canada as of August 30, 2007

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.

Permax is a member of a class of drugs known as dopamine agonists and has been marketed in Canada since 1991 for the treatment of Parkinson's disease. The risk of heart valve problems was first described in association with Permax in 2002. Over the years, the prescribing information for Permax was modified accordingly to include the latest safety information, and these safety concerns were communicated to Canadian healthcare professionals and patients in 2003 and again in 2004.

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.¹,² 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. and Health Canada anticipate there will be sufficient supplies in pharmacies to allow enough time for patients to safely switch to another product. Should pharmacy supplies run out and/or patients cannot be safely transitioned to other available anti-Parkinson's medications, physicians may contact the Special Access Programme at Health Canada to request temporary access to the drug for individual patients. In most cases, alternative therapies are available to treat Parkinson's disease. Availability of Permax through the Special Access Programme may be an option for patients who have failed to respond to alternative therapies.

Eli Lilly Canada has sent a letter to Canadian healthcare professionals informing them of this new safety information and that sales will stop as of August 30, 2007. A copy of the healthcare professional letter is available on the Health Canada website.

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected adverse reactions in patients receiving Permax^® should be reported to Eli Lilly Canada or Health Canada, at the following addresses:

The safety of patients remains a top priority for Eli Lilly Canada Inc. Should you have any questions about Permax, please contact the Eli Lilly Canada Customer Response Centre at 1-888-545-5972.

Sincerely,

original signed by

Loren D. Grossman, MD, FRCPC, FACP
Vice President, Research and Development
Eli Lilly Canada Inc.

PERMAX^® is a registered trademark of Eli Lilly and Company.

References:

1. Schade R, Andersohn F, Suissa S, et al. Dopamine agonists and the risk of cardiac-valve regurgitation. N Engl J Med 2007;356:29-38.

2. Zanettini R, Antonini A, Gatto G, et al. Valvular heart disease and the use of dopamine agonists for Parkinson's disease. N Engl J Med 2007;356:39-46.