In the consumer advisory we are instructing consumers as follows:

Transcription

1 Urgent Field Safety Notice Affected products: Poligrip Ultra and Poligrip Total Care Type of Action: Cessation of Manufacture and Distribution of our zinc-containing denture adhesives Date: 18 th February 2010 Dear Dentist, GlaxoSmithKline (GSK) has issued a consumer advisory warning consumers about a potential health risk associated with 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. Description of the problem 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. 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. In the consumer advisory we are instructing consumers as follows: 1. What Consumers Should Do: 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: Full details are attached. 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. This product does not need to be recalled or removed from the shelves. There is no safety or product issue when used as directed. This is a voluntary precautionary measure to stop manufacturing and distribution of the zinc-containing variants. Your GSK representative will be in touch with you concerning the timings of the zinc-free replacement product. If you have any Poligrip samples, please contact your GSK representative who can arrange for their return. In those countries where we currently market zinc-free variants you may continue

2 ordering these as normal. If you have any questions, please contact your local GSK representative. If you have any patients who describe neurological symptoms associated with long-term excessive denture adhesive use, you should refer your patient to his/her Doctor for assessment. We also ask that you report the case to us at Any other consumer queries can be directed to our consumer call line at Regards, Jeremy Meader Trading Director Pharmacy & Dental

3 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. o 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. Appendix:

4 UK Consumer Advisory This notice warns of the potential health risk from long-term excessive use of GSK s zinccontaining 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 For more information on Poligrip and zinc, go to

5 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. o 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: