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Zicam Comes Under Fire From FDA

anosmia, attorneys, Defective Drugs, FDA, injuries, loss of smell, Matrixx Initiatives, US Food and Drug Administration, warning letter, Zicam

June 16th, 2009: Washington Law Blogger

Matrixx Initiatives is a company that manufactures, markets and distributes a product line known as Zicam, which is an over-the-counter product sold to help with the symptoms of the common cold. It’s sold in several forms, including nasal spray and swabs, and at least partially as a result of Zicam’s success, Matrixx Initiatives’ stock price has risen and held steady even in the current marketplace.

However, negative news hit the wire today as the US Food and Drug Administration announced that it has sent a letter to Matrixx Initiatives instructing it to stop marketing Zicam unless the company decides to file an application for a drug approval with the agency to continue to market these products. If the company does so, Zicam will be subject to the same testing and analytical standards as any other medication.

The reason for this letter is that the FDA received at least 130 reports of consumers using Zicam products and developing a condition known in medical circles as anosmia, which is the loss of the sense of smell. Some consumers reported this side effect after only one use, and no duration for this side effect has yet been established. Therefore, the FDA is demanding a closer look at the product and the presence of one ingredient in particular, zinc, which has been linked to this side effect in other contexts.

There were three Zicam products subject to the FDA’s letter:

  • 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)

If you are currently using Zicam products, the FDA advises you to stop doing so. If you or someone you love has been injured as a result of using these products, contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.