FDA Cracks Down on Diabetes Drug Claims

Companies that promote their wares by making promises the products can’t possibly keep or by failing to disclose the full nature of their ingredients are nothing new. Especially in the drug trade. Last week, the FDA said “enough” to 15 pharmaceutical companies that the agency says violate a range of laws.

As reported by Reuters.com, the FDA warned 10 domestic and five foreign companies that their diabetes drugs-a total of 20-violate the law.

Some of them promoted as “natural,” according to the warning letters, contain pharmaceutical ingredients. Others are sold to people without prescriptions. Some falsely claim to cure or mitigate the symptoms of diabetes.

Howard Sklamberg, director of the office of compliance in the FDA’s drugs division, told Reuters that he considers health-care fraud in general, and particularly health-care fraud involving diabetes products, as “a large problem.”

The products are sold both in retail outlets and online.

Three of the most potentially dangerous cases the FDA identified come from Asia and have pharmaceutical ingredients not disclosed on the product labels They are:

  • Diexi (India);
  • Insupro Forte (Malaysia);
  • Jiang Tan Yi Juo Su Jial Nang, translated as Anti-Diabetic Pancreatic Capsule (China).

Diexi is made by Amrutam Life Care, and is promoted on the company’s website as an “anti-diabetic herbal formula that provides an effective treatment to relieve all symptoms related to diabetes.”

But the FDA says Diexi contains metformin, a 20-year-old pharmaceutical approved in the U.S. to treat diabetes under a physician’s supervision.

Easy Pha-max calls Insupro Forte a “Truly Saviour of Diabetics,” and claims it’s made with a plant-based protein that helps to lower blood sugar levels and repair damaged cells. But it contains glyburide, an FDA-approved diabetes medication that can cause serious side effects including low blood sugar if not taken properly.

Anti-Diabetic Pancreatic Capsule contains metformin, glyburide and phenformin, a drug that was removed from the U.S. market in the 1970s because it was associated with lactic acidosis. That serious condition can cause weakness, tiredness, muscle pain, trouble breathing and a sudden slow or irregular heartbeat.

According to a study in the journal Diabetes Care a few years ago, “phenformin-induced lactic acidosis (PLA) is still a public health problem.” The drug is still used in Italy, China and Brazil; 838,000 preparations of phenformin compound were sold in Italy alone between January and October 2005. Approximately half the people who get PLA die, and the report says that diabetes patients often have other conditions known to favor PLA.

In 2000, the journal article said, the FDA recalled five Chinese herbal medications containing phenformin.

Nearly 26 million Americans have diabetes. It raises the risk of heart disease, blindness, kidney failure and amputations of the lower limbs. For more information, see our backgrounder. In no case should you purchase or take any of the products listed above-they are unsafe, and potentially life-threatening.

If the companies that received the FDA warnings do not comply, the agency can prevent their products from being imported here, and it can seize those made domestically and initiate criminal proceedings.

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