Safety Concerns
Instances of anosmia (loss of smell) have been reported with intranasal use of some products containing zinc gluconate. In September 2003, Zicam faced lawsuits from users who claimed that the product, a nasal gel containing zinc gluconate and several inactive ingredients, negatively affected their sense of smell and sometimes taste. Some plaintiffs alleged experiencing a strong and very painful burning sensation when they used the product. Matrixx Initiatives, Inc., the maker of Zicam, responded that only a small number of people had experienced problems and that anosmia can be caused by the common cold itself. In January 2006, 340 lawsuits were settled for $12 million.
The U.S. Food and Drug Administration (FDA) considers zinc gluconate to be generally recognized as safe (GRAS) when used in accordance with good manufacturing practice, although this does not constitute a finding by the FDA that the substance is a useful dietary supplement. On 16 June 2009 the FDA "warned consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell. ... FDA is concerned that the loss of sense of smell may be permanent." Matrixx responded that the FDA's allegations were "unfounded and misleading", citing a lack of evidence from controlled tests that Zicam causes anosmia. In its warning, FDA stated, "This warning does not involve oral zinc tablets and lozenges taken by mouth. Dietary zinc is also not subject to this warning."
Read more about this topic: Zinc Gluconate
Famous quotes containing the words safety and/or concerns:
“Can we not teach children, even as we protect them from victimization, that for them to become victimizers constitutes the greatest peril of all, specifically the sacrifice—physical or psychological—of the well-being of other people? And that destroying the life or safety of other people, through teasing, bullying, hitting or otherwise, “putting them down,” is as destructive to themselves as to their victims.”
—Lewis P. Lipsitt (20th century)
“We do not marry for ourselves, whatever we say; we marry just as much or more for our posterity, for our family. The practice and benefit of marriage concerns our race very far beyond us.”
—Michel de Montaigne (1533–1592)