Loss of Sense of Smell Attributed to Use of Certain Zicam Products

On June 16, 2009, the U.S. Food and Drug Administration (FDA) issued a warning to consumers to discontinue use of Zicam intranasal products containing zinc.  According to the FDA, use of these products may cause loss of smell (anosmia).  Furthermore, the FDA suspects that this loss may be permanent.

The products specifically included in the warning are:

• 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)

The FDA has received over 130 reports of anosmia from the use of the Zicam intranasal products.  In addition to the health advisory warning advising people to stop taking the listed products, the FDA also sent a warning letter to the makers of Zicam informing them that Zicam can no longer be marketed without FDA approval. 

According to the FDA, loss of sense of smell is a “serious risk” for people who use the product.  Aside from the quality of life issue, the FDA points out that loss of smell can seriously endanger health by limiting one’s ability to detect the presence of gas, smoke or other environmental dangers.

The company which manufactures Zicam denies any causal link between the use of its products and anosmia.  However, it did agree to a voluntary recall of its nasal gel and nasal swab products and is offering a full refund or exchange for consumers who have already purchased these products.  Alternatively, you may wish merely to dispose of these products in a safe manner.  However, if you have taken one of the listed products and suffered ill effects, you should consult with an attorney before returning or disposing of any remaining product that you still have.

What is Zicam?
Zicam is an over-the-counter homeopathic remedy intended to reduce the intensity and duration of colds.   Homeopathy is a centuries-old approach to medicine which uses very small amounts of natural products in a heavily-diluted solution to treat various symptoms.  While the practice and use of homeopathic medicine does have its supporters, the scientific research supporting any actual benefits beyond the placebo effect is scant and controversial.

Products such as herbal supplements and natural remedies that do not contain active ingredients are not considered drugs and may be marketed without oversight from the FDA, except that they may not state that they have been proven effective in curing specific ailments or treating disease.  However, once the FDA has reason to believe that a particular product may be harmful, it does have authority to regulate that product in the interest of public safety.

As a homeopathic medicine, Zicam appears to occupy a hazy middle ground in the world of FDA regulation.  While the FDA allows homeopathic medicines to be marketed as drugs, it doesn’t necessarily regulate them to the same extent it does other medicines.  The FDA maintains two separate pharmacopeias, with a separate edition for homeopathic medicines.  A product containing ingredients found in either compendium should be regulated as a drug, but homeopathic medicines continue to occupy a lesser status in the eyes of the medical community.

The makers of Zicam themselves consider it to be a drug, as opposed to an herbal remedy or supplement, and point out that the active ingredient, zinc gluconate, is recognized as a drug in the homeopathic compendium to the FDA.  Moreover, the makers of Zicam very clearly state that their product has been clinically proven to lessen the duration and severity of the common cold.  Clearly, Zicam is a drug within the purview of the FDA’s regulatory authority. 

FDA History of Recalls, Lawsuits
The FDA has had to pull unsafe products off the shelves many times in the past.  You may remember names such as Ephedra, Fen-Phen and Pondimin.  The dietary supplement Ephedra was banned by the FDA in 2004 after receiving evidence linking the product to a high rate of severe side effects, including several deaths.  The makers and sellers of Ephedra have since faced billions of dollars in lawsuits, including a $12.5 million judgment against one manufacturer and a $7.4 million verdict against a seller of the product.  

Another diet aid, Pondimin, was removed from the market in 1997 after reports that it caused heart valve defects.  Pondimin (fenfluramine) was wildly popular when marketed in conjunction with another diet drug called phentermine.  The two drugs together were sold as Fen-Phen.  Thousands of lawsuits have been filed against the makers of Pondimin, who in 2000 settled a class action for nearly $12 billion.  As recently as 2004, a jury awarded a woman $1 billion in a Pondimin case.  Cases involving Ephedra and Pondimin continue to this day.

Seek Experienced Legal Representation
The extent of the damage caused by the Zicam products under recall is not yet known, but it is clear that a permanent or even long-term loss of smell can have serious adverse affects on one’s health as well as greatly diminish quality and enjoyment of life.  If you have suffered adverse effects from the listed Zicam products or other medications or herbal supplements, you should contact an experienced and knowledgeable attorney to discuss your rights. 

The attorneys at the National Justice Coalition are dedicated to helping the innocent victims of dangerous products.   Contact the National Justice Coalition to consult with a skilled lawyer familiar with the intricacies of litigation involving unsafe medical products.