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:
“Once women begin to question the inevitability of their subordination and to reject the conventions formerly associated with it, they can no longer retreat to the safety of those conventions. The woman who rejects the stereotype of feminine weakness and dependence can no longer find much comfort in the cliché that all men are beasts. She has no choice except to believe, on the contrary, that men are human beings, and she finds it hard to forgive them when they act like animals.”
—Christopher Lasch (b. 1932)
“History in the making is a very uncertain thing. It might be better to wait till the South American republic has got through with its twenty-fifth revolution before reading much about it. When it is over, some one whose business it is, will be sure to give you in a digested form all that it concerns you to know, and save you trouble, confusion, and time. If you will follow this plan, you will be surprised to find how new and fresh your interest in what you read will become.”
—Anna C. Brackett (1836–1911)