Smell-Loss Drug Escaped FDA Review Under Homeopathic Label
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By Shannon Pettypiece
June 26 (Bloomberg) -- Carol McDaniel blames her permanent loss of smell on the Zicam nasal spray, a cold remedy she thought would be safer than other medicines because it was sold as homeopathic.
Zicam’s 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 Zicam’s 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 -- don’t need marketing clearance from the FDA under U.S. rules. David Schardt, of the Washington-based Center for Science in the Public Interest says Zicam’s 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 didn’t 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. Zicam’s 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 that’s 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 couldn’t 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 don’t realize you’ll 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, Matrixx’s acting president, chief financial officer and chief operating officer, in a June 24 interview. He said he didn’t believe the company had to turn over the 800 consumer complaints it had received.
The company conducted four studies involving hundreds of patients taking Zicam that didn’t find any loss of smell, Hemelt said. One was published in the October 2000 issue of Ear Nose and Throat Journal, and another in the January 2003 issue of QJM, a medical journal published by Oxford University Press.
“I’m 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
Zicam’s 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 Health’s 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 FDA’s 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.”
Robert Henkin, director of the Washington-based Taste and Smell Clinic, which treats patients with taste and smell dysfunction, said he has had patients who lost those sensory abilities from using Zicam since 1999, when the product was introduced. Zinc’s side effect is widely known among taste and smell specialists, said Henkin.
“It can be devastating,” said Henkin. “Food itself might have no taste or an unusual taste, like burned or rotten or metallic and there is no way out of it for them. Twenty-four hours a day they have this with them,”
FDA Response
The FDA said its action against Zicam doesn’t mean the agency will be increasing its oversight of all homeopathic products.
“The FDA is always re-evaluating its processes to ensure that we are adequately and appropriately protecting the public health,” said FDA spokeswoman Siobhan DeLancey in an e-mailed statement. “The recent Zicam action is based on the safety signals indicating that the products may cause a particular adverse event, and the homeopathic claim by Matrixx Initiatives only serves to explain how these products reached the marketplace without pre-market review by FDA.”
Homeopathy was founded in the late 1700s by German chemist Samuel Hahnemann, based on the principle that a disease can be treated using small, diluted doses of a substance that trigger symptoms similar to the disease in healthy people. The active ingredients in homeopathic products are sometimes so miniscule that they are undetectable, according to the NIH.
For a substance to be considered homeopathic, it must be listed in the Homeopathic Pharmacopeia, which is compiled by the Homeopathic Pharmacopeia Congress of the United States. The group sets guidelines for testing and verifying clinical effectiveness, though it has no enforcement capabilities, said Mary Borneman, a spokeswoman for the organization. The FDA regulates the manufacturing of homeopathic products and can request they be withdrawn if a safety issue arises.
Industry Concerns
Zicam’s recall has raised concerns among homeopathic industry officials. According to Borneman, the Zicam nasal products, because the medicine is inserted into the nose rather than taken orally, doesn’t meet the guidelines of the homeopathic congress. Applying zinc in the nose hasn’t been tested by the industry group, she said.
“We do not support the idea that anyone can make a homeopathic medicine on a whim and if you are going to make a homeopathic medicine you have to understand the science of it,” Borneman said. “Undoubtedly people will try to get something by and the FDA is there to regulate it.”
Zicam’s recall also prompted the American Association of Homeopathic Pharmacists to post a statement on its Web site saying that the FDA’s action “does not apply” to the homeopathic “class of drugs as a whole.”
Love Gum
Almost 4 million U.S. adults use homeopathic medicines, according to a 2007 NIH report. Many products, such as Oscillo, a flu treatment whose main ingredient is from duck liver, and Head-On, which includes derivatives of iris, potassium, and a plant called White Bryony, can be bought at retail drugstores.
Since 2005, sales of Matrixx’s homeopathic cold remedies have jumped 43 percent to $79 million in the fiscal year ended March 31 and sales of Quigley’s Cold-Eeze another zinc-based homeopathic product, increased 13 percent to $25.73 million in 2008, according to the companies.
Matrixx first started in Utah making herbal-based chewing gum, such as Love Gum to enhance romantic desire and Brain Gum to improve brain function, according to regulatory filings by the company. It started as Nekros International Marketing Inc., changed its name to Gum Tech International Inc. and then in 2001 to Matrixx of Scottsdale, Arizona.
The company started selling Zicam in 1999 when it partnered with a division of closely held Zengen Inc. of Woodland Hills, California, that developed drug delivery systems. Matrixx decided to focus solely on Zicam in 2001 when it sold its gum business to Wm. Wrigley Jr. Co. for $25 million and bought the full rights to Zicam.
McDaniel said she will think twice now about using other homeopathic products in the future.
“I also use an allergy drop that is a homeopathic medicine and now I’m wondering if that is safe,” McDaniel said.
To contact the reporters on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net;
Last Updated: June 26, 2009 00:01 EDT |
