Did the FDA Recall the Cold Remedy Zicam?

Did the FDA recall the cold remedy Zicam?

Shares of Matrixx Initiatives Inc. plummeted 70 percent on Tuesday as the makers of the popular Zicam cold remedy products were slapped with something akin to an FDA recall.

According to the FDA, use of Zicam (the main ingredient of which is zinc) can lead to temporary or even permanent loss of smell. Still, the FDA stopped short of officially recalling the product.

Cold sufferers should stop using Zicam Cold Remedy, both their popular nasal gel and other zinc containing products, because of the threat of permanent loss of the sense of smell, according to the FDA’s press release issued on Tuesday. Scientists and FDA officials say that the zinc found in Zicam may damage nerves in the nose which are necessary for our sense of smell. Two other big selling Zicam products that will be affected by the Food and Drug Administration’s recall announcement are both the adult and child doses found in Zicam Cold Remedy Nasal Swabs. The FDA reports that over 130 Zicam consumers have reported some loss of smell after using the popular Zicam products in the last decade. This announcement caused Matrixx Initiatives stock price to hit its lowest point ever.

The recall by the FDA comes as a minor shock — normally, the FDA doesn’t get involved with herbal remedies, which Zicam is classified as. In fact, Zicam was never a part of a formal FDA approval process because it is part of that group of remedies which are almost never required to undergo any FDA review before being sold to the public. Zicam is considered a “homeopathic product”. However, when any product sold to Americans appears to be dangerous, the government has the right to step in.

Dr. Charles Lee, head of the FDA’s compliance unit, said this about the recall yesterday. “Loss of the sense of smell is potentially life threatening and may be permanent. People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or a fire in the house.” For their part, Matrixx Initiatives defended the safety of their products, but did backpedal to say that they will most likely remove them from the marketplace.

Health officials from the FDA and other goverment organizations have said they will ask Matrixx Initiatives executives to hand over a large backstock of consumer complaints (somewhere in the neighborhood of 800 reports) concerning the loss of smell. The FDA says that any document the company has on file related to this claim will be inspected. A new law passed in 2007 requires manufacturers to report these kind of problems with their products, but the FDA is staying mute on the issue of whether Matrixx broke the law or not. The 130 plus reports used by the FDA to make this semi recall are from doctors and their patients, not from Matrixx.

A letter sent to Matrixx Initiatives on Tuesday asked the company very firmly to “stop marketing its zinc based products”, but in truth, the Food and Drug Administrationdid not go so far as to issue a true recall. To bypass the recall process, FDA regulators insisted that Matrixx Initiatives has to submit safety and efficacy data on the drug before attempting to sell it to the public. This means that the next step for Matrixx, if they’d like to continue selling Zicam, is to approach the FDA and seek that organization’s formal approval.

Does Zicam pose a danger to people who use it? Medical records aren’t 100% clear, but do seem to support patient’s claims that the use of Zicam was directly linked to their loss of smell. As for why Matrixx Initiatives would want to continue selling Zicam, the answer is simple. The homeopathic cold remedy market is huge, and Matrixx wants to maintain a piece of that pie. In fact, the worldwide market for homeopathic drugs in general runs into the hundreds of millions.

Unknown to most of the public, Matrixx Initiatives has settled hundreds of lawsuits connected with Zicam out of court in the past ten years, but still claims on its Web site that ” . . . no plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.” If this were totally true, why would Matrixx be paying off people who sue for damages?

In a statement released late Tuesday, Matrixx Initiatives stated that the safety of Zicam Cold Remedy is “supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists.” But the FDA says it is unaware of any real scientifc data supporting Zicam’s claims and what they write on the product’s label. Matrixx makes some serious claims about Zicam, including that the drug “reduces cold symptoms”, including “sore throat, stuffy nose, sneezing, coughing and congestion.” If that sounds like a drug label to you, you’re not alone.

Matrixx said it will most likely withdraw the products in question, which earned that company around 40 percent of its $111.6 million in sales in the last year alone.