Zicam or Ziscam? -Effectiveness (or not), Risks and the FDA

 

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Zicam or Ziscam? -Effectiveness (or not), Risks and the FDA

Zicam® advertises heavily during the cold weather months that its product will shorten the duration of colds.  But there's much more behind the story than the rah-rah ads tell you.

What Zicam® ads don't tell you...

1. The FDA has taken actions against them, and the makers of Zicam® stopped selling the nasal spray form of the product. 
2. Zinc can cause harm, including the loss of the sense of smell.
3. Homeopathic does NOT automatically mean "safe".
4. Zicam's products are NOT approved by the FDA.
5. There appears to be little independent, objective, credible research from 3rd party researchers at major universities or other similar credible institutions (without ties to Zicam's manufacturers or affiliates), that supports their claims.  Certainly no research that is conclusive and broadly accepted by medical experts. .
6. At best (according to research cited below), zinc, in some forms, may shorten colds by a fairly insignificant amount.

Yay!  Homeopath!  Doesn't homeopathic mean it is safer?

The FDA warned that this is not true:

What should consumers know about homeopathic products?
Products labeled as homeopathic and currently marketed in the U.S. have not been reviewed by the FDA for safety and effectiveness to diagnose, treat, cure, prevent or mitigate any diseases or conditions.

And in 2015, the FDA published this on their website (click here for the full statement on the FDA.gov website):

A similar OTC cold remedy, Zicam® (Matrixx Initiatives, Inc. NJ) states that each lozenge contains Zincum aceticum and Zincum gluconicum at "2X",2 representing a dilution of 1 to 102 (1:100), or 1% concentration. What consumer-or health professional-knows what this nomenclature or dose information means? In this case the drug label provides no useful information to an average consumer or  clinician. And those who can interpret the concentration still won't know how many milligrams of zinc are in the product.  
Although zinc is an essential element, excessive zinc can can suppress copper and iron absorption and cause other toxic effects. 3 Adverse effects caused by some  Zicam® products have resulted in litigation4 and an FDA Warning Letter5 to this company.

Doesn't Zinc, like in Zicam, shorten colds?

The Mayo Clinic says that is uncertain and debated, and if it does shorten colds, it is does not shorten them by much, for example, to 20 days instead of 21 days... :

There's been a lot of talk about taking zinc for colds ever since a 1984 study showed that zinc supplements kept people from getting as sick. Since then, research has turned up mixed results about zinc and colds.
Recently an analysis of several studies showed that zinc lozenges or syrup reduced the length of a cold by one day, especially when taken within 24 hours of the first signs and symptoms of a cold.

OK, so 1 day less is still better, right? Maybe...if it really did.. BUT  The Mayo Clinic goes on to say:

None of the studies analyzed had enough participants to meet a high standard of proof. Also, the studies used different zinc dosages and preparations (lozenges or syrup) for different lengths of time. As a result, it's not clear what the effective dose and treatment schedule would be.

LiveScience says:

Sadly, none of this suggests that zinc sprays or lozenges even cure a cold. Studies have been mixed, with the majority lending no support for zinc-based cold therapy.

Did Zicam® say anything about the side effects?

Funny, they don't mention side effects in their commercials. Like possibly losing your sense of smell.

The Mayo Clinic:

Zinc - especially in lozenge form - also has side effects, including nausea or a bad taste in the mouth. Many people who used zinc nasal sprays suffered a permanent loss of smell.

Let's look at the FDA's warnings:

In 2009, the FDA warned consumers about Zicam:

June 16, 2009: FDA is alerting consumers that Zicam® Cold Remedy Nasal Gel, Zicam® Cold Remedy Nasal Swabs, and Zicam® Cold Remedy Swabs, Kids Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia).

Zicam® Class-Action Lawsuit

The makers of Zicam® were sued and had to pay consumers. See details of the lawsuit here. Other legal actions are apparently still pending. .

 

Conclusion

It sure doesn't look like zinc, in any form, is worth the risks, and zinc-containing products aren't worth it! The nasal spray has been removed from the market. Do you really want to try the lozenge version?

So concludes Consumer Reports in "6 Reasons Not to Take Zinc for Your Cold, This supplement isn't worth the money or the risk of side effects" By Lauren Cooper, January 26, 2016 

 

Other references:

1. U.S. F.D.A. - Homeopathic Product Regulation: Evaluating FDA's Regulatory Framework After a Quarter-Century
   April 20, 2015, Testimony of  Adriane Fugh, Berman MD, Associate Professor, Dept. of Pharmacology and Physiology
   Georgetown University Medical Center
2. FDA Investigation of consumer complaints
   See https://www.fda.gov/media/78612/download
3. Forbes, The Top Five Cold Remedies That Do Not Work
   by Steven Salzberg, November 17, 2014
4. Amy Tuteur, MD:
   The Zicam® scam and the gullibility of the American public
5. Everyday Health - FDA warns consumers to discard Zicam® products
    By Ed Zimney, MD, June 18, 2009  -In an unusual move earlier this week, the Food and Drug Administration (FDA) alerted consumers that Zicam® Cold Remedy products have been associated with long lasting or even permanent loss of smell. FDA recommends that consumers stop using these products and that they throw away any that might still be in their homes. The affected products include Zicam® Cold Remedy Nasal Gel, Zicam® Cold Remedy Nasal Swabs, and Zicam® Cold Remedy Swabs, Kids Size (the last one is a previously discontinued product).
6. FDA NEWS RELEASE, FDA Advises Consumers Not To Use Certain Zicam® Cold Remedies Intranasal Zinc Product Linked to Loss of Sense of Smell
   June 16, 2009
   Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov. Consumer Inquiries: 888-INFO-FDA
   
   FDA Advises Consumers Not To Use Certain Zicam® Cold Remedies
   Intranasal Zinc Product Linked to Loss of Sense of Smell
   The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
   
   The products are:
   --Zicam® Cold Remedy Nasal Gel
   --Zicam® Cold Remedy Nasal Swabs
   --Zicam® Cold Remedy Swabs, Kids Size (a discontinued product)
   
   The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam® products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.
   
   "Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason."
   
   People who have experienced a loss of sense of smell or other problems after use of the affected Zicam® products should contact their health care professional. The loss of sense of smell can adversely affect a person's quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.
   
   The FDA has issued Matrixx Initiatives, maker of these Zicam® products, a warning letter telling it that these products cannot be marketed without FDA approval.
   
   "Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold," said Deborah M. Autor, director of CDER's Office of Compliance.
   
   Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
   --Online
   --Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
   --Fax: 800-FDA-0178
   --Phone: 800-FDA-1088
   
   For more information:
   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm
   
   
7. Snopes.com.  They also examined Zicam® and didn't really take a position, but noted that the makers of Zicam® removed the nasal spray form of Zicam® from the market:
   

   In June 2009, however, the FDA issued an advisory cautioning consumers not to use Zicam® brand nasal gel and nasal swabs because the agency "has received more than 130 reports of loss of sense of smell associated with the use of these Zicam® products." The FDA also issued a warning to Matrixx informing the company that it could no longer market the specified nasal products until those products have been subjected to safety testing and FDA approval.
   
   In response, Matrixx issued a statement asserting that its products are safe and that the FDA's actions were unwarranted. Nevertheless, it has withdrawn the products in question from the market.