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Poli-Grip - Association of Long-Term, Excessive Use of Zinc-Containing Poli-Grip Products with Myeloneuropathy and Blood Dyscrasias - For Health Professionals

Starting date:
February 18, 2010
Posting date:
February 23, 2010
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-170002344

This is duplicated text of a letter from GlaxoSmithKline Consumer Healthcare.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Poli-Grip

February 18, 2010

Subject: Association of long-term, excessive use of zinc-containing Poli-Grip products with myeloneuropathy and blood dyscrasias

Dear Health Care Professional,

GlaxoSmithKline in consultation with Health Canada would like to inform you of the potential health risk from long-term excessive use of GSK's zinc-containing denture adhesives Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh'. As a precautionary measure, GSK has voluntarily stopped the manufacture, distribution and advertising of these products. Recent publications and reports suggest that excessive use of these products, typically for several years, may lead to the development of excessive levels of zinc in the blood (associated with copper deficiency). The reports describe the development of myeloneuropathy and blood dyscrasias. Neurological symptoms may include sensory disturbance, limb weakness and difficulty walking.

  • Excessive use of zinc-containing denture adhesives over several years may result in the development of myeloneuropathy and blood dyscrasias
  • GSK has voluntarily stopped the manufacture, distribution and advertising of zinc-containing denture adhesive products to prevent the potential risks associated with excessive use
  • Patients who have used Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh' in accordance with the instructions are not at risk of excessive zinc intake.

It is important to note that zinc is not absorbed through the mouth, remaining bound to the adhesive and is only absorbed when swallowed. A small amount of adhesive is swallowed during normal use. This is not considered to be harmful.

Patients who have used Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh' in accordance with the instructions are not at risk of excessive zinc intake. A typical 50g tube should last 4 to 6 weeks.

In certain instances, some patients might apply more adhesive than directed and use it more than once per day, usually due to ill-fitting dentures. These patients should be advised to discontinue this practice and consult their dentist for advice.

We have instructed denture wearers who have used GSK zinc-containing dental adhesives Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh' in excess of the product directions for several years, or are concerned about their health to discontinue use, consult with their doctor, and switch to a zinc-free alternative.

Patients with suspected cases of myeloneuropathy and blood disorders associated with long-term excessive denture adhesive use should be referred to an appropriate health care professional for assessment. We also ask that you report the case to GSK at 1-888-521-8033.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any case of serious sensory disturbance, limb weakness and difficulty walking or other serious or unexpected adverse incidents for medical devices in patients using Poli-Grip should be reported to GlaxoSmithKline Consumer Healthcare or Health Canada at the following addresses:

GlaxoSmithKline Consumer Healthcare
2030 Bristol Circle
Oakville, Ontario
L6H 5V2
1-888-521-8033

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Regards,

original signed by

Dr. Howard Marsh
Chief Medical Officer
GlaxoSmithKline Consumer Healthcare

Hedera P, et al. (2009) Myelopolyneuropathy, and pancytopenia due to copper deficiency and high zinc levels of unknown origin II. The denture cream is a primary source of excessive zinc. Neurotoxicology 30: 996-999.

Nations SP, et al. (2008) Denture Cream: an unusual source of excess zinc, leading to hypocupremia and neurologic disease. Neurology 71:639-643.