According to Dr. Charles E. Lee, medical officer in the division of New Drugs and Labeling Compliance in CDER's Office of Compliance, the agency has received more than 130 reports from people using one of these zinc-containing products about the loss of a sense of smell, also known as anosmia.
"The loss of the sense of smell is potentially life-threatening and may be permanent," Lee said. "People without the sense may not be able to detect dangerous situations such as gas leaks, something burning in the house, or if food is spoiled before eating it. It also has a life-limiting effect, and can affect the livelihood of people in occupations where the sense of smell or taste is a crucial component."
Lee pointed out that, while the rate of adverse events seen here may not seem high, adverse events reports for over-the-counter drugs are historically low because consumers typically file their complaints with companies, not the FDA.
Until 2007, there was no requirement for makers of over-the-counter products to provide adverse event reports to the agency.
All reports of the latest problem have come from consumers and health-care providers, and Autor said the company has more than 800 adverse event reports related to the loss of sense of smell it has been asked to turn over to the FDA.
She declined to elaborate further on these reports, simply saying, "They have not been provided to the agency at this time."
Lee said the first reports of something amiss came in 1999, but seemed to speed up after 2004.
In 2006, Matrixx agreed to pay $12 million to settle several hundred lawsuits from consumers who claimed the zinc products had stripped them of their sense of smell. At the time, Matrixx said the settlements were not an admission of liabi
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