On June 16, 2009, the US Food and Drug Administration (FDA) warned people to stop using Zicam products marketed as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
The products causing problems are:
- Zicam Cold Remedy Nasal Gel
- Zicam Cold Remedy Swabs
- Zicam Cold Remedy Swabs, Kids Size
What Is Zicam?
Zicam is an over-the counter homeopathic medication that is supposed to reduce the duration of the common cold. It contains Zinc, considered a supplement; however, the FDA fears that the ingredients may cause nerve damage.
Why Is Zicam Harmful?
Zinc, the main ingredient of the nasal spray, is used to impair smell in laboratory animals and may cause permanent damage to your sense of smell.
The FDA has received more than 130 reports of loss of ability to smell associated with the use of these three Zicam products. Many people who experienced a loss of smell said they noticed it with the first dose, others reported it after several uses.
David Richardson of Greensboro, North Carolina says he is forced to live life "like watching a sunset in black in white" after losing his sense of smell as a result of using Zicam. Richardson, 46, says in an Associated Press report, "There's not a day that goes by that you're not reminded of it."
Richardson says he used Zicam just once for a stuffy nose when his mother, a retired nurse, offered him some. Richardson told the AP that when he held the gel to his nose and inhaled, he immediately felt a burning sensation, but figured his reduced sense of smell was the lingering effects of the cold.
Matrixx Initiatives, the manufacturer of Zicam, claims these products are perfectly safe and there is no link between a loss in the sense of smell and the medication. However, Matrixx has already faced lawsuits in the past. In 2006, the company agreed to pay $12 million to 340 Zicam users who said the products cost them their senses of smell. Matrixx still faces at least 17 lawsuits and hundreds more claims from patients who have reserved their rights to sue in the future.
Meanwhile, their stock plummeted by 56% on the NASDAQ - the worst loss since its initial public offering in 1996.
Matrixx has offered Zicam users full refunds and agreed to stop all shipments and sales of the products pending FDA review. The company has a video explaining the recall with a FAQ and refund information on its Web site.
If These Products Are Dangerous, Why Are They Sold to the Public?
Zicam products were never reviewed or approved by the FDA because they are considered homeopathic therapies, such as vitamins and herbal remedies. These are not considered drugs by the FDA and don't need FDA approval to be sold. However, the FDA has now ordered Matrixx to stop selling these products and submit a new-drug application. Furthermore, Matrixx must turn over the complaints they received, currently at least 800.
What Should You Do?
If you have experienced a loss of your sense of smell or other problems after use of the affected Zicam products, you should contact your doctor.
Health care professionals and consumers are encouraged to report any side effects that may be related to the use of these products to the FDA's MedWatch Adverse Event. For more information please click here.
Can You Sue?
If you used Zicam and lost your sense of smell, you may be entitled to monetary compensation from Zicam's manufacturer. You should contact a products liability lawyer who can investigate the details of the injury and determine whether or not it was caused by Zicam. Once the cause has been determined, the attorney will be able to file a claim to try to get compensation for your injury and to ensure that the manufacturers are held accountable. A lawsuit can seek payment for your:
In the meantime, stop using any Zicam product and check in with the FDA Web site for further updates.