Gluconium Side Effects

Zincum gluconium, also known as zinc gluconate, is a compound of the mineral zinc, in which two molecules of gluconate are bonded to each molecule of zinc. Gluconium is a popular dietary supplement and is an ingredient in the over-the-counter cold remedy Zicam. Although the FDA classifies gluconium as safe, concerns about its side effects have been raised since the agency warned in 2009 that the use of certain forms of Zicam can lead to a loss of smell.

Features

• Gluconium is not known to have any side effects, at least not in the doses available in dietary supplements or in food. The FDA states that gluconium is generally recognized as safe when manufactured under proper conditions. This means that although it has not passed the FDA's general requirements for food additives, it has become recognized through scientific procedures or through general use as safe for consumption, if taken under certain prescribed conditions.

Warning

• In September 2003, the makers of the over-the-counter cold remedy Zicam were sued by users who claimed that three of its nasal products, which contained gluconium and several other inactive ingredients, damaged their sense of smell and taste. Some plaintiffs said the product caused a painful burning sensation. In 2006, 340 of these lawsuits were settled for $12 million.

Significance

• In June 2009, the FDA warned that the use of any of three Zicam nasal products could damage or destroy a person's sense of smell. The FDA had received over 130 reports of anosmia, the loss of sense of smell, traced to the use of two types of Zicam swabs and one type of nasal gel. Many experienced a loss of smell after only one dose, although others lost their sense of smell after several doses. These losses may be permanent. The FDA issued a public health advisory warning consumers not to use the Zicam products. The makers of Zicam responded by removing the products from their shelves.

Considerations

• The FDA made clear that its warning about the use of Zicam did not apply to the use of oral zinc tablets and lozenges, or to dietary zinc. The FDA explained that zinc is an essential part of the human diet, contributing to a healthy immune system and critical for normal growth. The FDA, however, recommends that the best way to get one's daily requirement of zinc, and of other essential vitamins and minerals, is to consume the mineral in food as part of a balanced diet.

Expert Insight

• According to the New York Times, Dr. Charles E. Lee, a compliance officer in the FDA's drug center, said that zinc could be toxic to nasal nerve receptors. Lee said that, in the 1930s, intranasal zinc was tested as a means of preventing polio, but caused some patients to lose their sense of smell.