FDA cracks down on illegal, alternative diabetes treatments
Most patients with diabetes seek treatment from a medical provider, but sometimes patients turn to natural or over-the-counter remedies instead. The problem: some of these products may be ineffective or dangerous. Now the U.S. Food and Drug Administration is working to pull many of these illegal products from the market in an effort to protect public health.
The FDA has moved to stop U.S. sales of nearly two dozen products illegally marketed as diabetes treatments, reports The Wall Street Journal. The agency has sent warning letters to the affected companies that threaten potential criminal prosecution and seizure of products it says can be ineffective, counterfeit or, in some cases, dangerous. Banned products include dietary supplements, self-styled "natural treatments," and ayurvedic medicines, which are promoted as part of an alternative health system from India that includes herbs and special diets.
"These people are fraudsters who are scamming people and creating risks that people are going to get very sick," Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, told NBC News.
Diabetes treatment is big business in the U.S. Marketplace reports that an estimated 26 million Americans suffer from the disease, and the market for prescription diabetes medication was worth about $22 billion last year. Health consultant Jerry Katz said sales for these drugs have grown by 60 percent over the last four years. He said he believes makers of diabetes supplements -- like those now targeted by the FDA -- want to piggyback on this growth.
According to The Wall Street Journal, the FDA is warning consumers that the products might not only be ineffective; they might be contaminated. They often lack warning labels that detail potential side effects. Perhaps one of the biggest concerns, however, is that patients who take them might put off necessary medical treatment, which could increase their risk of developing serious health complications.
"All patients with diabetes need to be under the care of a licensed health care professional," Dr. Karen Mahoney, an FDA safety reviewer, told NBC News. "You need to go to a doctor. If they're taking on one of these products, they should stop."
The FDA notes in a press release that it has not yet received reports of injury or illness associated with the illegally sold products, but is moving to protect the public health from any harm they might post. It encourages patients and health care professionals to report any adverse reactions to its MedWatch program at 1-800-FDA-0178. The Agency has created an online photo album on flickr that includes photographs of all the implicated products, and offers a complete listing of them on its website. It said the products are often available for purchase from both online and retail outlets.
"FDA alerts companies to stop illegal sale of treatments for diabetes," fda.gov, July 23, 2013
"FDA Moves Against Alternative Diabetes Treatments," wsj.com, July 23, 2013, Thomas M. Burton
"Illegal diabetes products draw 15 FDA warnings," nbcnews.com, July 23, 2013, JoNel Aleccla
"Illegally Sold Diabetes Treatments," flickr.com
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