FDA Issues Warning Regarding Zicam Nasal Spray

By on June 16, 2009 - Comments off

In a conference call with a group of reporters this morning the FDA announced it is warning users of Zicam, a popular cold-relief nasal spray, to stop using the product because it has been associated with approximately 130 reported cases of people losing their sense of smell.

The FDA stated that it had sent Matrixx Initiatives, Inc., the manufacturer of Zicam, a warning letter directing the company to stop marketing the internasal products. The agency also instructed Matrixx that it must seek FDA approval if it wishes to continue selling zinc-containing versions of Zicam administered through the nose.

No recall has been ordered because the FDA’s authority is limited for regulation of over-the-counter homeopathic remedies such as Zicam. Although Matrixx denies that the product can cause a loss of smell, the company indicated that it will consider withdrawing the products from the market.

Several lawsuits have already been filed against Matrixx, asserting that Zicam nasal gel has caused permanent loss of smell (anosmia) and taste in users, some after a single application of the product. Zicam contains soluble zinc gluconate, a substance known to be linked to olfactory nerve damage when applied through the nose, which has been associated with anosmia since the 1930’s.

Shares of Matrixx Initiatives Inc. (MTXX) dropped 56% to $8.56 in recent trading after hitting a 52-week low of $8.41 earlier in the day.