Drug Defects: October 2009 Archives

October 27, 2009

FDA Sticks to Zicam Cold Remedy Warning Letter on Loss of Smell

The U.S. Food and Drug Administration (FDA) has refused to back down from a warning letter sent to Zicam manufacturers, Matrixx Initiatives, Inc., regarding the potential dangers of its over-the-counter cold medication.  In June 2009, the FDA warned consumers that three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kids Size (discontinued product) -- were associated with 130 reports of the loss of sense of smell (also known as anosmia).  According to the FDA, the loss of sense of smell reportedly occurred after the first dose of the drug, but is also known to occur after multiple doses.

The potentially dangerous Zicam products contain zinc gluconate (labeled "zincum gluconicum") as the active ingredient.  The FDA warns on its website that although these products are marketed to reduce the duration and severity of the common cold, the products have not been shown to be effective in doing so.  Consumers are advised not to use the potentially dangerous drugs for any reason and to throw away any remaining product.  Matrixx Initiatives has since pulled the products in question from the market, but the FDA fears that unknowing consumers will use products still stored in their medicine cabinets.

In the June 2009 warning letter, the FDA accused Matrixx Initiatives of failing to provide any data to establish that Zicam Cold Remedy intranasal products are safe and effective for the uses identified in their labeling.  On the contrary, the FDA said that there is published scientific literature that evidences various salts of zinc can damage olfactory function in humans.

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October 5, 2009

Florida Woman First Fosamax Multidistrict Litigation Plaintiff

Ironically, 71-year-old Shirley Boles took Fosamax (the brand name for alendronate) to increase her bone density, but instead the Walton Beach, Florida woman found her jawbone deteriorating, her teeth loosening, and her gums turning black. This condition resulting in jawbone death is known as osteonecrosis of the jaw (ONJ).

Boles took Fosamax from 1997 to 2006 and asserts that Merck, the manufacturer, failed to warn doctors about the relationship between the drug and ONJ. There are now approximately 900 plaintiffs participating in the class action against Merck. This first lawsuit is being heard this month in the US District Court in Manhattan.

A study performed at the University of Southern California School of Dentistry and reported in the Journal of the American Dental Association (Jan. 1, 2009) found that 1 in 23 of the 208 patients studied taking alendronate had active ONJ. Researchers noted that even short-term use of alendronate was correlated with ONJ in some patients after certain dental procedures.

According to an article in USA Today (March 13, 2005) the chairman of the division of oral and maxillofacial surgery at the University of Miami, Robert Marx, stated that he knew of 40-50 cases of ONJ nationwide in patients who had taken Fosamax.

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