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drug_recall cold-eezeCold-Eeze is a popular homeopathic cold remedy sold over the counter across the country. Made by Quigley Corp., the products contain zinc gluconate. Unlike over-the-counter medications and prescription drugs, homeopathic product sales are allowed unless the FDA proves them to be harmful. Herbal products and homeopathic remedies, like Cold-Eeze, are regulated separately and there are only a few quality control and labeling rules laws.
The popularity of homeopathic remedies really took off when Cold-Eeze and another zinc product called Zicam entered the market. Cold-Eeze products claim to ease symptoms and shorten the duration of the common cold. With lozenges, gums and sugar free tablets already on the market, Quigley announced in February 2003 that it was introducing Cold-Eeze Cold Remedy nasal spray.
After the nasal spray hit the market, the safety of zinc gluconate nasal sprays came under review following reports that people lost their sense of smell after using the products. A Quigley spokesman said there were no reports of problems among 80 people involved in a study of Cold-Eeze, but reports that people lost their sense of smell after using the nasal sprays led the FDA to say it was evaluating complaints related to the products.
Reports of anosmia, the clinical term for loss of smell, were being made among Cold-Eeze users as well as Matrixx Initiatives’ Zicam Cold Remedy nasal gel users. Both companies said anosmia reports among some of the zinc spray users might be coincidence because viruses producing cold symptoms can cause anosmia, which is why they may have gotten the nasal spray to begin with.
By February 2004, Quigley said it had received just four complaints about the nasal spray related to anosmia but had sold about 100,000 bottles. Quigley continued to maintain their product was safe, pointing to the “double-blind, placebo-controlled study to evaluate product safety,” as well as referring to one of its consulting medical specialists involved in the Cold-Eeze study for its zinc gluconate product. Dr. Carl Whitley, a nose and throat specialist involved in the Cold-Eeze study, described the smell test as being “crude” since it was not the goal of the Cold-Eeze study.
There is a lack of science offering definitive evidence on the risks of zinc nasal sprays like Cold-Eeze, and a number of doctors caution their patients that the possible risk of anosmia is not worth fewer days of a cold. After Quigley became the target of lawsuits claiming its zinc nasal spray caused anosmia, the company pulled it from the market, claiming disappointing sales in September 2004, just a year after it first hit the shelves.
The Quigley Corporation reported its gross margins for 2004 would have increased had it not suffered $1.4 million one-time costs related to the discontinuations of the nasal spray, which included a $672,000 write-off of nasal spray inventory and a $680,000 reduction to net sales resulting from anticipated customer returns of the product.
Cold-Eeze products are not as highly diluted as some homeopathic products, and Albert Piechotta, director of marketing and communications for Quigley, says the zinc contained is not “microscopic by any means.” The increase in net sales for the year ended December 31, 2004 and had an 11.5 percent increase in the Cold-Eeze Cold Remedy segment despite the incidence of colds during 2004 being less than the previous year. The company attributes this increase to successfully expanding targeted advertising, marketing initiatives and new product extensions of Cold-Eeze.