Providing yet more evidence that the Food and Drug Administration needs to get better control of certain parts of the market, it took about ten years to issue a warning about Matrixx Initiatives, Inc.'s (MTXX) Zicam Cold Remedy. The cold nasal gel and swabs can permanently damage the sense of smell, the FDA now warns.
Losing the sense of smell is more dangerous than it may sound, as "People without the sense of smell may not be able to detect life dangerous situations, such as gas leaks or something burning in the house," Dr. Charles Lee told the AP.
Why just a warning then? Why not issue a recall? It's not clear. Perhaps partly because Zicam is a homeopathic remedy that doesn't actually require FDA approval in the first place. All the FDA has done is ask the company to stop marketing its zinc-based products, though it is also now requiring formal approval and says Matrixx will have to submit safety and effectiveness data on the drug.
As for Matrixx, it insists Zicam is safe, and on its website lists no side effects other than drowsiness or stinging. That's despite settling hundreds of lawsuits related to Zicam in recent years. Not surprising, I guess, given Zicam accounts for about 40 percent of its revenue.
Other than homeopathic drugs, the FDA also doesn't fully regulate vitamins and supplements, mostly due to being under-staffed. Only a few months ago the Government Accountability Office, the investigational arm of Congress, reported the number of "side effects from supplement products have jumped threefold since December 2007 when companies were forced to start telling the FDA about consumer side effects," according to Reuters.
Many are calling for the FDA to improve its oversight of vitamins and other dietary supplements, and probably homeopathic medicines too. The public, it seems, cannot believe claims by manufacturers regarding safety and efficacy.
Zicam's own claims, for example, that the drug reduces cold symptoms, are not supported by data government scientist can attest to. And if it doesn't relieve cold symptoms, let alone "gets rid of the cold three times faster," then why take the drug in the first place? And when it comes to vitamins, for example, taking too much of one vitamin can also be dangerous, as studies found regarding Vitamin C and A. These seem to be just the tip of the iceberg.
We certainly don't need another ephedra case, which took the FDA nearly 10 years to pull weight-loss products containing the ingredient from the market, despite thousands of reported problems and deaths from consumers. The FDA needs to improve oversight or we are back to the days when anyone can roll into town and sell snake oil as a cure-all.
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