Zicam has been one of the highest-selling over-the-counter cold medications on the market in recent years, and its manufacturer, Matrixx Initiatives, has enjoyed a solid stock value as a result. However, that all changed today as the company received a letter from the US Food and Drug Administration ordering the company to stop marketing Zicam unless the company decides to apply for a drug approval with the FDA.
The reason for the letter and public warning is that the FDA has received at least 130 reports of consumers using Zicam products and suffering from a loss of the sense of smell. No duration of this sensory loss has yet been defined, but it’s believed that the ingredient responsible for the development of this side effect is zinc. Zinc has been linked to the loss of smell in several other contexts.
There were three specific products that came under FDA scrutiny:
- Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
- Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
- Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)
Matrixx Initiatives issued a response on its Web site, that says in part:
“Based on the FDA’s action, the company has suspended shipments of these products and will reimburse any customer desiring a refund. However, the company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products. Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. (Ed’s note: Anosmia is the medical term for the loss of smell) For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company’s product safety data.”
Whether Matrixx Initiatives is correct in its assertions is a matter for another time. In the meantime, follow the advice of the FDA and stop using these products. If you have been injured as a result of using Zicam products, contact the defective products lawyers at the Phillips National Injury Group as soon as possible to schedule a free initial consultation.
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June 17th, 2009 at 4:06 pm
[...] the heels of yesterday’s news that the FDA had issued a public warning to stop using Zicam, the company responsible for the product line’s presence on the market, [...]