Posts Tagged ‘FDA’

To date, the FDA has not issued any advisory to the public or the profession on this issue.

Nearly 35 million people in the United States wear dentures and many of the widely used denture adhesives previously contained zinc. If a denture wearer used large amounts of the adhesive, and swallowed it, there are claims that a person could receive too much zinc, potentially resulting in a lowering of copper and possible serious neurological issues.

Since 2009 lawsuits have been filed claiming inadequate warning labels on Poligrip and Fixodent alerting wearers to potential effects of too much zinc consumption. There is a recent resurgence in television advertising for such lawsuits and it is important to note that zinc containing denture adhesives have been pulled by major manufacturer, GlaxoSmithKline. Zinc-free is now clearly shown on packaging.

• American Dental Association (ADA) statement on Zinc in Denture Cream, click here.

Denture wearers are advised to see their dentist if their dentures do not fit well or if they have questions about the use of dental cream. Dental examinations and appropriate care can reduce the need for denture adhesive products. Regular dental checkups are important for everyone, including denture wearers.

On April 30, 2010 the US Food and Drug Administration (FDA) together with manufacturer McNeil Consumer Healthcare issued a voluntary recall of specific children’s over-the-counter (OTC) medicines. It is important to note that the recall is specific for certain lots of Children’s Tylenol, Motrin, Zyrtec and Benadryl and that the medicines being recalled are all liquid, drops or syrup.

Tylenol, Motrin, Zyrtec, and Benadryl are safe medications – the recall is in effect for reasons of concentration or contamination.

• For complete information, please see the FDA web page on this topic, click here.
• Further information about a refund or coupon if you have one of these recalled products, click here.
• For additional information about the use of Tylenol (acetaminophen) and Motrin (ibuprofen) in children see this information from the American Academy of Pediatrics, click here.