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Zicam Recall Points to Potential Problems with Homeopathic Remedies

Jun 22, 2009 | Parker Waichman Alonso LLP

Last week's Zicam recall is raising some serious questions about the safety and regulation of homeopathic remedies.  According to a new report by the Associated Press, more than 800 homeopathic ingredients were potentially implicated in health problems last year.

Last week, the Food & Drug Administration (FDA) said it had received 130 reports of anosmia - loss of sense of smell - in people who had used three Zicam nasal remedies. During a conference call to announce the Zicam alert, the FDA also said Matrixx Initiatives had received an additional 800  anosmia reports it hadn’t made available to the agency.  Following the FDA alert, Matrixx Initiatives recalled two of the products - Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

Zicam products are considered homeopathic remedies.  Homeopathy is generally defined as a system of medical treatment based on the use of minute quantities of remedies that in larger doses produce effects similar to those of the disease being treated. Homeopathic remedies like Zicam do not require FDA approval, and they do not have to be proven safe or effective before going on the market. However, the agency can intervene when there’s evidence a homeopathic drug may pose a risk to consumers.

Homeopathic medicines are very popular.  According to the Associated Press, sales of homeopathic drugs hit $830 million last year.  What's more, in 2007 such remedies were taken by more than 4 million Americans.

Most American's who use homeopathic drugs do so with the assumption that they are safe.  But the Associated Press dug up some disturbing facts about these products.  For instance, some homeopathic remedies contain far more alcohol  than what is allowed in traditional medicines.  In fact, the FDA has acknowledged that some homeopathic syrups far surpass 10 percent alcohol.  

The Associated Press also found that  least 20 ingredients used in conventional prescription drugs are also used in homeopathic remedies. This includes  digitalis for heart trouble and morphine for pain.  Homeopathic medicines have also been made  from cancerous and diseased tissues, and  poisons such as strychnine, arsenic or snake venom.

There's also very little evidence that homeopathic remedies are useful.  In fact, according to the Associated Press, National Institutes of Health's alternative medicine center spent millions investigating homeopathic drugs, but quit when very little evidence was found to support their effectiveness.