FDA Issues Warning About Popular OTC Cold Drug

The Food and Drug Administration issued a letter of warning to Matrixx Initiatives in June concerning three of the company's zinc-containing Zicam Intranasal products in June. The FDA said consumers should stop using these products and discard them immediately because they may a loss of sense of smell. 

The warning is applicable only to those Zicam products that contain zinc, which include the following (along with size and product number):

• 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)

Since 1999, the FDA has received more than 130 complaints about loss of smell connected to Zicam's intranasal products that contain zinc. In some cases, loss of smell occurred after the first dose. The FDA has reported that the damage could be long-lasting or permanent, and this type of loss of smell is referred to as anosmia. Oral cold medications containing zinc are still deemed safe.

Dr. Janet Woodcock, director of the FDA's Drug Evaluation and Research, said that losing one's sense of smell is a major risk for people using these products in an interview with CNN.

 "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."  

After receiving the warning, Matrixx Initiatives responded through a press release by saying the allegations leveled by the FDA were unfounded. The company said it plans to present additional data to the FDA to prove the safety of these products.

In the meantime, Matrixx issued a voluntary recall of the products listed in the FDA's letter, and has notified retailers, wholesalers, and distributors to have the drugs pulled from the shelves. Consumers may also return previously purchased product.

Matrixx has had a number of lawsuits filed against them over the products.

The FDA has asked health care professionals and consumers to report possible new cases associated with these products through the MedWatch program, either online or by phone at 1-800-FDA-1088.

Find more information about diagnosing and treating the Common Cold here.

--By Charity Scott