Navigation Links
FDA Issues Warning for Over-the-Counter Cold Remedy
Date:6/16/2009

Zicam nasal products can cause loss of smell, officials stress

TUESDAY, June 16 (HealthDay News) -- U.S. health officials on Tuesday warned consumers to stop using Zicam nasal cold remedy products because they can cause the loss of a sense of smell.

The specific products contained in the warning include Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids' Size.

"These products claim to reduce the duration of the common cold and severity of cold symptoms," Deborah M. Autor, director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration, said during a morning teleconference Tuesday. "Consumers should stop using these products immediately."

The kids' products have been discontinued, but consumers may still have them in their households and are advised to discard or return them, officials said.

The products' manufacturer, Matrixx Initiatives, also received a warning letter and "must provide FDA with a plan on how it will remove existing inventory from the marketplace," Autor said.

"We have asked Matrixx in a warning letter to stop marketing the products, and we intend to work with them to address the products on the market and, at the same time, warn consumers to stop using and discard or return them," Autor continued. "We expect to hear a plan from the company."

According to Autor, the products have been marketed as homeopathic remedies and, therefore, have not needed FDA approval as long as the company complied with certain labeling and manufacturing requirements.

Now, the FDA is essentially asking Matrixx to take the unusual step of recalling the product, and then filing for new drug approval.

"The next step is for the company to come in and seek FDA approval if they want to continue marketing the products," Autor said.

"While the company has done trials involving small numbers of patients, we believe there have not been enough patients exposed in those trials to detect infrequent adverse events," she said.

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 liability, the Washington Post reported.

According to Lee, both animal studies and historical medical literature indicate that zinc is actually toxic to the nerve receptors in the nose. Zinc was apparently used in the 1930s to try to prevent polio infection, he said.

More information

The National Library of Medicine has more on anosmia.



SOURCES: June 16, 2009, teleconference with: Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration; and Charles E. Lee, M.D., medical officer, Division of New Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, FDA; Jan. 30, 2006, Washington Post


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. College Mental Health Expert and Sister of Student Who Died By Suicide Available to Discuss College Mental Health Issues
2. PowerBar Issues Open Call for 2008-2009 PowerBar Team Elite(TM) Athlete Sponsorship Program
3. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
4. American Red Cross Issues Blood Supply Alert
5. OSHA Issues Draft Ergonomics Guidelines on Preventing Musculoskeletal Injuries in Shipyards
6. New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
7. National Quality Forum Issues First Consensus Standards for the Treatment of Substance Use Conditions
8. Audio: New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
9. Dallas-Area Transplant Meeting Puts Spotlight on Key Issues
10. Elder Care Author Doctor Marion Launches Second National Tour to Raise Awareness About Aging & Elder Care Issues in America
11. California State PTA Issues Statement Regarding Presidents Veto of SCHIP Legislation
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Issues Warning for Over-the-Counter Cold Remedy 
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... Lice Troopers, ... lice cases in families with school-aged children since the holiday season. , “It ... holidays with their families, sharing hugs and taking photos, which is the head-to-head gateway ...
(Date:1/20/2017)... ... , ... "TransFlare 4K Mystique comes with 44 colorful mysterious transitions that are ... Austin - CEO of Pixel Film Studios. , TransFlare 4K Mystique contains 44 ... flare and light leak transitions have a very high-dynamic range for super smooth falloff. ...
(Date:1/20/2017)... ... ... Word: Chocolate Biscuit”: a biographical account following a man who went on to support his ... Marlyn Ivey, born in Lynn Haven, Florida and at the age of 5, his family ... age, he joined the Navy and got married right out of boot camp. , ...
(Date:1/20/2017)... ... ... beautiful and enchanting tale that teaches children the true meaning of Christmas. “Journey to Christmas” ... and a devoted woman of faith. , “Becoming a parent changes you. In my ... mind for years, but actually doing it might have been a while in coming if ...
(Date:1/19/2017)... ... January 20, 2017 , ... Today, the Centers for Medicare & Medicaid Services ... Alternative Payment Models (APMs) in 2017. Clinicians who participate in APMs are paid for ... part of the Administration’s effort to build a system that delivers better care and ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... RATON, Fla. , Jan. 19, 2017 /PRNewswire/ ... a medical device company specializing in the treatment ... such as keloids, with superficial radiation therapy, today ... and full year 2016 financial results on Thursday, February ... The Company will hold a conference call with ...
(Date:1/19/2017)... ALTO, Calif. , Jan. 19, 2017   ... research, is excited to announce that the first ... Cancer Biology  (RP:CB) have been published in eLife ... this project represents the first practical evaluation of ... result in reproducible studies. Unlike other assessments of ...
(Date:1/19/2017)... , January 19, 2017 ... appears serious about reducing the FDA,s regulatory strictness ... in the medical drug industry, many of the ... new clinical trials and development of advanced drug ... ahead with recent developments include:  Moleculin Biotech, Inc., ...
Breaking Medicine Technology: