The U.S. Food and Drug Administration (FDA) has yet to take decisive action despite mounting evidence that links denture creams to severe neurological side effects. Classified as a Class 1 medical device, denture creams such as GlaxoSmithKlines Poligrip and Procter & Gambles Fixodent are subject to very limited FDA control. Denture cream manufacturers must register their products with the FDA, notify the agency before they begin marketing them, and adhere to sound manufacturing techniques and labeling practices. But otherwise, so-called low risk Class 1 devices such as denture creams do not require clinical trials or face similarly strict forms of control that other medical devices do.
It seems unlikely, however, that clinical trials would have uncovered the connection between the zinc contained in some denture creams, copper deficiency, and nerve damage. It has been many years since Fixodent and Poligrip were classified as Class 1 medical devices, and scientific literature on zinc-related neuropathy is new. Still, the research thats been done strongly suggests that ingesting the zinc in denture cream can cause serious neurological disease. GSK, facing public scrutiny and lawsuits, reformulated Poligrip without zinc, with the company stating in February that it had, become aware of potential health problems associated with the long-term excessive use of our zinc-containing denture adhesive products. P&G apparently is not as concerned as its competitor, as it still sells Fixodent containing zinc. Stating that Fixodent only contains half the zinc as Poligrip, the company merely placed a warning on its Web site.
As litigation against both companies gains momentum, Procter & Gamble may capitulate on its decision to manufacture Fixodent with zinc. The publication of additional scientific findings linking the zinc in denture creams to neurological problems might have a similar effect. While researchers have known about the link between too much zinc, too little copper, and neurological problems for some time, it was only in the last few years that they began to understand that the zinc in denture creams was a likely culprit in patients with neuropathy.
The first such study was completed by researchers from the University of Texas Southwestern Medical Center in Dallas and published in the journal Neurology in 2008. The doctors conducting the research studied four patients, all of whom suffered from hypocupremia (reduced copper content of the blood) and hyperzincemia (zinc toxicity). By analyzing clinical and laboratory data, the doctors concluded that the only logical explanation for the subjects excessive zinc intake was the use of denture creams. Soon after these groundbreaking findings were published, a Vanderbilt University neurologist conducted another study that analyzed eleven patients with high zinc levels. Consistent with the University of Texas findings, all eleven were found to be denture cream users.
It should be noted that many of the patients in the studies described above used large amounts (up to two tubes per week) of denture cream, which is not necessarily typical. But GSK and P&G have done little to clarify how much denture cream is safe. Before it ceased manufacturing Poligrip with zinc, GSK included an insert in the product packaging that read, For Best Results Start With a Small Amount. On its Web site, the maker of Fixodent similarly suggests: Start with a small amount at first. Bearing in mind the severe potential side effects of zinc toxicity, though, such precautions are clearly insufficient.
In fact, this is what many injured consumers are claiming in lawsuits against the manufacturers of Fixodent and Poligrip. One of the principal allegations made against GSK and P&G is that these companies failed to provide adequate warnings about the dangers of zinc poisoning from denture creams. The companies argued that when used as directed, their products are safe. But due to the vague directions they provided, the extensive scientific literature available linking zinc to neurological problems, and a failure to even name zinc as an ingredient on product labeling until after the University of Texas study was published, manufacturers surely could have made patient safety a higher priority.
If you are a Fixodent or Poligrip user who has been found to have zinc poisoning, hypocupremia, hyperzincemia, neuropathy, or health problems related to excessive zinc or insufficient copper levels, you might have grounds for a lawsuit against GlaxoSmithKline, Procter & Gamble, or another denture cream manufacturer. The Rottenstein Law Group can assess your
denture cream lawsuit settlement claim and answer any questions you have. With more than 25 years of experience representing consumers injured by companies that placed profits over safetyconsumers like youRLG knows how to hold irresponsible companies responsible. We simplify the process of seeking compensation while treating you with compassion and sympathy.
