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    Friday, July 3, 2009



    Homeopathic remedies are said to be safe—at least not harmful because the “active ingredients are so diluted.” The FDA, however, is alerting consumers that ZICAM COLD REMEDY NASAL GEL, ZICAM COLD REMEDY NASAL SWABS, and ZICAM COLD REMEDY SWABS, KIDS SIZE, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia). These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms. However, these products have not been shown to be effective in the reduction of the duration and severity of cold symptoms. This advisory does not yet cover oral zinc tablets and lozenges taken by mouth.FDA recommends that consumers stop using these products and throw them away. See the FDA website for How to Dispose of Unused Medicines.

    800 Zicam complaints from FDA.
    The company didn't turn over to US regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs." The company halted sales of "the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell." The agency "found 800 reports of consumer concerns in May during a routine inspection.

    Since the introduction of Zicam Cold Remedy Nasal Gel to the market in 1999, FDA has received reports of anosmia associated with the use of Zicam zinc-containing intranasal products. The reports vary. Many people state that the loss of sense of smell occurred with the first dose of the Zicam product, although some people report it happened after later doses. The loss of sense of smell may be long-lasting or even permanent in some people.

    Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food. Also, loss of the sense of smell is often linked with a loss of the sense of taste. People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating. Further, there is evidence in the published scientific literature that various salts of zinc can damage olfactory function in animals and humans.

    Zicam and hundreds of other homeopathic remedies — highly diluted drugs made from natural ingredients — are legally sold as treatments with explicit claims of medical benefit. Yet they don't require federal checks for safety, effectiveness or even the right ingredients. They're somewhat similar to dietary supplements, which use many of the same natural ingredients and also aren't federally tested for safety or benefit.

    Many scientists view homeopathic remedies as — ineffective but mostly harmless because the drugs in them are present in such tiny amounts.But an Associated Press analysis of the Food and Drug Administration's side effect reports found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.
    In its review of homeopathy, the AP also found that:

    _ Active homeopathic ingredients are typically diluted down to 1 part per million or less, but some are present in much higher concentrations. The active ingredient in Zicam is 2 parts per 100.

    _ The FDA has set strict limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies. The American Academy of Pediatrics has said no medicine should carry more than 5 percent alcohol. The FDA has acknowledged that some homeopathic syrups far surpass 10 percent alcohol.
    _ The National Institutes of Health's alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007 but is now abandoning studies on
    homeopathic drugs. "The evidence is not there at this point," says the center's director, Dr. Josephine Briggs.

    _ At least 20 ingredients used in conventional prescription drugs, like digitalis for heart trouble and morphine for pain, are also used in homeopathic remedies. Other homeopathic medicines are derived from cancerous or other diseased tissues. Many are formulated from powerful poisons like strychnine, arsenic or snake venom
    Homeopathy sprang from the inventive — some would say fanciful — mind of German physician and chemist Samuel Hahnemann in the late 1700s. Experimenting on himself, he became convinced that if an ingredient causes a symptom in a healthy person, it will treat the disease that causes the same symptom. He also theorized that diluting ingredients to minuscule, even untraceable, concentrations paradoxically makes them more powerful. To this day, homeopaths put forth mystical-sounding explanations involving "vital force" and "healing energy, with arcane ingredients and names like "nux vomica" and "arsenicum album.”.

    Since 2002, the U.S. homeopathic remedy market exploded by 89 percent to an estimated $830 million last year, according to market research company Mintel. By 2007, homeopathic remedies were taken by almost 4 million Americans, or 2 percent of adults, federal data show.

    Though many homeopathic remedies consist mostly of sugar or alcohol, thousands of patients swear by their effectiveness anyway.

    The FDA's own side effect reports potentially implicate at least 843 homeopathic ingredients just in the year ending September 2008, the AP found. It is impossible to verify how many were taken at low homeopathic concentrations. But dozens apparently were, and they were linked to side effects, including muscle and joint pain in reports submitted by consumers, doctors and others.

    According to the FDA letter to the Zicam company “a homeopathic drug product marketed without an approved NDA is not subject to the enforcement discretion. But when there is evidence of a safety risk associated with the product, as is the case for the Zicam Cold Remedy intranasal products, the Agency enforces the Act’s new drug approval requirement, a provision that is essential to protect the public health by holding firms responsible for demonstrating, based on adequate and well-controlled clinical investigations, that a product is safe and effective for each of its intended uses before marketing it. Therefore, an approved NDA is required for the Zicam Cold Remedy intranasal products, regardless of their homeopathic status. Your introduction of the Zicam Cold Remedy intranasal products into interstate commerce, without an approved application, violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a).

    Additionally, Zicam Cold Remedy intranasal products are misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), because their labeling does not bear adequate warnings regarding the risk of anosmia associated with the product. In light of this failure to bear adequate warnings, these products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), taking into account the considerations set forth in section 201(n) of the Act, 21 U.S.C. § 321(n).


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