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

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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.

Public Communication
Health Canada Endorsed Important Safety Information on Poli-Grip

February 18, 2010

Subject: GlaxoSmithKline (GSK) warns about a potential health risk associated with long-term, excessive use of zinc-containing denture adhesives: Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh'

This communication is to alert consumers to a potential health risk from long-term excessive use of zinc-containing denture adhesives: Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh'.

Advanced Care

Extra Strength

Ultra Fresh

While zinc is an essential part of the diet, recent publications suggest that an excessive intake of zinc-containing denture adhesives over several years may lead to the development of neurological symptoms. These may include numbness, tingling or weakness in the arms and legs, difficulties with walking and balance and blood problems such as anemia.

Poli-Grip is safe to use as directed in the product label (see below). However, some consumers apply more adhesive than directed and use it more than once per day. Therefore, as a precautionary measure to minimize any potential risks to these consumers, GSK has voluntarily stopped the manufacture, distribution and advertising of these zinc-containing products.

GSK will soon be introducing zinc-free versions of Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh'. Zinc Free will be clearly shown on the new packaging.

Consumers with questions may call GSK at 1-888-521-8033.

For more information on Poli-Grip and zinc, visit www.gsk.com.

Label Information

Poli-Grip 'Advanced Care', 'Extra Strength' and 'Ultra Fresh' directions for safe and effective use:

Directions: Poli-Grip holds all day. Apply once a day for secure hold. Start with a small amount. Using too much adhesive can cause oozing. If oozing occurs, use less adhesive next time. Do not apply more than once a day. A 50 g tube should last about 4 to 6 weeks. If not, you are using too much adhesive which may be a sign of ill-fitting dentures. See your dentist regularly. Routine dental examinations are part of good oral health and necessary to check the fit of your denture.

Applying

1. Clean and dry your dentures.
2. Apply adhesive in two or three short ¼" strips, not too close to denture edges.
3. Rinse mouth before inserting dentures.
4. Press dentures in place, hold firmly, and bite down for a few seconds to secure.
   • To keep tip from clogging, keep cap and nozzle dry.

Removing

1. Swish mouth with water.
2. Slowly remove dentures by using a rocking motion.
3. Remove denture adhesive residue from denture and mouth with warm water and a soft brush.
4. Use Polident Denture Cleanser to thoroughly clean your denture.

Important Product Information:

• This product contains zinc. Talk to your doctor before using this product if you are taking daily zinc supplements.
• Do not use if you have sensitivity to any of the cream ingredients. If discomfort occurs discontinue use.
• Swallowing small amounts of this product, when used as directed, may occur and is not harmful.
• Use only as directed. Using excessive amounts of this product over a prolonged period of time has been reported to result in serious health effects from increased zinc intake.

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-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious numbness, tingling or weakness in the arms and legs, difficulties with walking and balance and blood problems such as anemia 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: