UK Consumer Advisory

This notice warns of the potential health risk from long-term excessive use of GSK’s zinc-containing denture adhesives Poligrip Ultra and Poligrip Total Care. As a precautionary measure GSK has voluntarily stopped the manufacture, distribution and advertising of these products.

At GSK, consumer safety is our primary concern. GSK continuously monitors published scientific literature and the adverse events we receive in relation to all our products. There are a variety of sources of zinc and it is an essential part of a healthy diet. However, in 2009 we received an increased number of adverse event reports. Together with published literature, these suggest that excessive use of these products, typically for several years, may lead to the development of high levels of zinc in the body which are associated with neurological symptoms, such as numbness, tingling or weakness in the arms and legs, difficulties with walking and balance and blood problems such as anaemia. These reports are very rare, given that several million people are users of the products.

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

Poligrip Ultra and Poligrip Total Care are safe to use as directed in the product label (see below). The majority of consumers follow these directions. However, some consumers apply more adhesive than directed and use it more than once per day, usually due to ill-fitting dentures.

What consumers should do

1. Those who have been using the product correctly may continue to do so safely. Ensure that you are using the products as directed on the package:

"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 typical 40g tube should last about 6 weeks. If you are using too much adhesive, this 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."

2. If you have been using zinc-containing Poligrip Ultra and Poligrip Total Care for several years in greater amounts than directed on the package, for example:
  • Using adhesive more than once per day, or
  • Using adhesive a shorter time than directed on the label - a typical 40g tube should last about 6 weeks, or
  • You have concerns about your health,
you must
  • Stop using the product.
  • Talk to your doctor.
  • Use a zinc-free alternative adhesive.

Consumers with questions may call GSK at 0800 988 6366

For more information on Poligrip and zinc, go to www.poligrip.co.uk

Appendix

Full Directions for safe and effective use:

Poligrip 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 typical 40g tube should last about 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 6mm strips, not too close to denture edges (as shown in picture on pack).
  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 a 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.

Affected product images:

Poligrip Ultra

Poligrip Total Care

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