Smell-loss Drug Escaped Fda Critique Below Homeopathic Label
Zicams homeopathic label allowed it to be marketed for a decade without a review for safety or effectiveness by the U.S. Food and Drug Administration, until its recall on June 16. Doctor and consumer reports to the FDA and Zicams maker, Matrixx International Inc., showed the Zicam nasal sprays and swabs may have caused more than 900 people to lose their sense of smell, U.S. regulators said June 16.
Homeopathic products — over-the-counter remedies that use plant, mineral or animal derivatives — dont need marketing clearance from the FDA under U.S. rules. David Schardt, of the Washington-based Center for Science in the Public Interest says Zicams recall and mainstream use highlight a need for more oversight of homeopathic products, a $200 million market, according to the American Association of Homeopathic Pharmacists.
“Homeopathic products used to be this small cult and this backwater type of thing,” said Schardt, a senior nutritionist at the center. “That has changed and they are now becoming more and more common and distributed in an entirely different way. It has become a can of worms.”
Matrixx didnt alert U.S. regulators to about 800 reports it received from Zicam users who said they lost their sense of smell. The FDA found the reports only after an inspection in May. Zicams main ingredient is zinc, which since the 1930s has been linked to loss of smell when applied inside the nose. A group overseeing homeopathic drugs says thats an improper use.
Sold at Wal-Mart
Zicam became a household name helped by television, radio and print advertising campaigns, with Matrixx spending $24.4 million last year, according to data from The Nielsen Company in New York. Major retailers such as Wal-Mart Stores Inc., Target Corp., Rite Aid Corp. and CVS Caremark Corp. sold Zicam.
The recalled Zicam nasal sprays and swabs, which sold for about $11 a box, had $44 million in sales last year, according to Matrixx. The entire line of 19 Zicam products, including liquid medicines and chewables, generated $111 million in revenue for the company in the year ending March 31.
McDaniel, 50, who works for a real estate developer near Columbus, Ohio, said she used Zicam last year at the maximum daily dose for about a week to treat a stuffy nose. When her sinuses cleared, she noticed her sense of smell was mostly gone. A bowl of chili now smelled like onion and she couldnt tell whether a gas stove was left on or detect burning odors.
“I used to be able to smell wood burning down the road,” said McDaniel in a telephone interview. “I miss that, it is something you dont realize youll miss until it is gone.”
Standing by Zicam
Matrixx, of Scottsdale, Arizona, stands by the safety of its products and plans to meet with the FDA to try to get the agency to reverse its decision, said William J. Hemelt, Matrixxs acting president, chief financial officer and chief operating officer, in a June 24 interview. He said he didnt believe the company had to turn over the 800 consumer complaints it had received.
“Im going to do everything I can and so will the rest of the employees to see that we can build a business around the 16 products we still have on the market,” said Hemelt. “But what we would like to do is get the FDA to reverse its decision.”
Active Ingredient
Zicams active ingredient, zinc, is believed to shorten the duration of a cold by preventing the viruses from attaching to cells in the nasal passages called ICAM-1 receptors, according to a study in the Journal of the American Pharmacists Association by researchers at Case Western Reserve University in Cleveland. Many studies have tested zinc in colds, and results are conflicting, according to a search of the National Institutes of Healths archive of published medical research.
Some research suggests zinc may be toxic to nerve receptors in the nose that are involved in smell, said Charles E. Lee, a medical officer with the FDAs office of compliance, in a June 16 conference call with reporters. More than a dozen studies from an NIH database show that zinc causes loss of smell in animals.
70-Year-Old Suspicions
Scientists have suspected the mineral could cause loss of smell in people since the 1930s when a zinc-based nasal spray was tested to prevent the spread of polio, Lee said. A 1938 study published in Journal of Pediatrics found that some patients who got the polio treatment lost their sense of smell.
More recently, a 2004 study by University of Colorado researchers in the Journal of Rhinology concluded that zinc gluconate “raises significant concern regarding its safety for intranasal application in humans.”