Archive for the ‘Zicam’ 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.

Zicam: Smelling Trouble

Wednesday, July 8th, 2009

Welcome to corporate America and non prescription drug marketing. Matrixx Initiatives, maker of over-the-counter-health care products is best-known for its Zicam Cold Remedy swabs, hit a speed bump June 16 when the FDA advised consumers to stop using two of its remedies. Trouble began over six years ago when Forensic Advisors, set up by a former U.S. Attorney and CPA, Tim Mulligan, published a report describing what he called aggressive accounting practices at the company resulting in investigations by the S.E.C.  Mulligan’s report also warned that Matrixx might not be able to supply the F.D.A. with adequate support for its claims that Zicam reduces severity of cold symptoms.

According to the New York Times, the report noted criticism in medical journals which supported his findings.A month after the report, ENT specialists at a meeting of the American Rhinologic Society presented several cases of smell loss after the use of zinc-laced nasal gels.As early as 2003 consumers began to file lawsuits against Matrixx. In the meantime Mr. Mulligan and Forensic Advisors were named in a defamation suits by Matrixx, eventually causing him to shut down his research operation after two years battling outrageous  legal assaults and threats by the company. Later, with the emergence of more cases and official recognition by the F.D.A. these legal tactics were unmasked as a false and misleading attempt to silence a vocal critic. Mulligan was cleared, but his public crusades against corporate criminality were halted. We can only hope he returns to the fray, despite the legal perils of being a public whistle blower. It is indeed a shame and a disgrace that it took the F.D.A .in  over 130 cases reported to them since 1999 to confirm that Zican could cause anosmia (loss of smell). In fact, Matrixx Initiatives, settled approximately 340 cases in January 2006 involving people who alleged anosmia following use of Zicam. The S.E.C. is still investigating the company for accounting irregularities.

Matrixx Initiatives previously took the position that Zicam was a homeopathic drug not subject to FDA regulation. Yet, after the FDA issued the warning letter June 16 stating the products no longer can be marketed without FDA approval, more questions have arisen about the approval of over-the-counter drugs, supposedly enjoying certain exemptions from the Food and Drug Act.

No one knows  how many users of the nasal gel or spray developed this often permanent condition, anosmia. If one assumes the usual 10% reporting rate, thousands could be affected.  Moreover, loss of taste-the appreciation of flavors is-modulated by the sense of smell. Multiple class action suits have been filed against the company.

In the meantime Matrixx shares have fallen 71% since the F.D.A. announcement. This is not a surprise considering that Zicam cold remedies generated $78 million of the company’s $112 million revenue last year. I wonder what will emerge from further studies of cold remedies, their effectiveness and potential dangers.