Zicam, sold since 1999 as a cold remedy, was never tested by the FDA for safety like most drugs. Because Zicam is homeopathic, the FDA did not test the drug before it hit the market. However, after more than 130 Adverse Events Reports, the FDA could no longer ignore the problem. On June 16, 2009 the FDA warned customers to stop using Zicam Nasal Swabs and Nasal Gel Spray. The reason: too many reports of anosmia or loss of smell. On the same day as the consumer warning, the FDA sent a warning letter to Matrixx Initiatives, makers of Zicam, to stop marketing the nasal cold remedy products. The letter also stated that Zicam would have to be tested for safety and efficacy, just like other drugs before it is available again to consumers.
More than 1 billion doses of Zicam have been sold since 1999 according to the associated press. In 2006, Matrixx settled about 340 Zicam cases for $12 million dollars. The company claims it settled the cases to limit its legal exposure, but the settlements beg the question, just when did Matrixx know of the dangers of its products?
Many consumers were shocked to learn that products like Zicam don't have to pass any tests for safety before hitting store shelves. The protection for homeopathic medicines is almost the dirty little secret of the industry. In fact, Albert Lambert, retired deputy director of the FDA's unit overseeing drug labels, calls it "a big fraud" on the consumer.
According to an Associated Press article, homeopathic remedies have seen a resurgence in the last decade, with the market for these medicines growing by 89% since 2002. By 2007, homeopathic remedies were taken by almost 4 million Americans the article reported. In 2008, homeopathic medicine was an $830 million dollar industry according to the article. Hopefully the wide spread news coverage of the serious side effects from Zicam will force regulators and lawmakers to consider testing homeopathic medicines before they can be marketed. In the meantime, Matrixx can expect a new wave of claims from its customers who have lost the sense of smell.
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