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FDA Adverse Reports, Fixodent, and Zinc Toxicity Lawsuits

As of August 2010, the FDA is not aggressively pursuing the relationship between Fixodent and zinc toxicity. There is no Fixodent recall at this time.

However, that doesn't mean that other researchers are waiting for the FDA to take the lead.

Here's a condensed version of a FDA adverse event report of a male patient who used Fixodent dental adhesive for 20 years, up to three tubes a week on his upper and lower dentures. Patient was suffering from pre-leukemia, myelopathy, bone marrow toxicity, and low levels of copper. His daily living activities were impaired as he had decreased mobility and numbness in his feet and hands. Patient suffered high levels of zinc in his bloodstream, decreased blood copper levels, and ulcers in his mouth. The patient was unable to do his job; thusly, gave it up. He received antibiotics and antifungal treatments but his symptoms were ongoing.

Here's yet another condensed version of a FDA adverse event report of a female patient who wore dentures for 16 years using Fixodent denture adhesive, Original Cream one application, twice a day. She too was diagnosed with zinc toxicity. All the nerves in her hands and feet were dead and she couldn't walk or use her hands. She frequently vomited, lost weight/hearing/ and balance and felt like her body was shutting down. She was referred to a neurological clinic where numerous tests were performed and medications prescribed. Although she sees a doctor regularly and has numerous treatments, she became disabled.

In another report from the FDA database a male patient used Fixodent from approximately 2003 until now (6 years). While using Fixodent I began experiencing tingling in my foot and hand. The complaint said he/she used Fixodent daily and even after stopping the use of the denture adhesive cream, the tingling did not subside.