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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

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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 GlaxoSmithKline Consumer Healthcare.
Contact the company for a copy of any references, attachments or enclosures.

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.

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:

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.