Archive for the ‘Zinc’ Category

More on Over-the-Counter Drugs and Zicam

Friday, July 10th, 2009

If a manufacturer calls an over-the-counter drug a “homeopathic product” the company does not require any Agency approval. A problem with the present law is the F.D.A. does not have the power to order product recalls in the case of over-the-counter medications, but must rely on manufacturers to do so voluntarily. In the past the Government sometimes negotiated for weeks before companies agreed to recall a product. Yet Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always complied with requests to do so. This, despite the fact that early reports to the F.D.A. of loss of smell from Zicam date back to 1999.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but never provided those reports to the F.D.A.,likely in violation of F.D.A. requirements that all reports of product-related injuries be sent to the Agency. Bills now moving through Congress would give the agency that power, thus restoring legislation existing prior to 1994. (But that’s another story in itself, the crippling changes in Federal rules regarding over-the counter drugs enacted over 15 years ago.)

The warning letter from the F.D.A. sent to Matrixx states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert.

The disabling loss of the sense of smell may be long lasting or even permanent, and may result in life-threatening consequences such as inability to detect dangers such as gas leaks or smoke. Moreover, as pointed out in my last blog, without the sense of smell people usually lose the sense of taste and the pleasure of eating, profoundly affecting the quality of life.