New York: The US Food and Drug Administration (FDA) moved to block the sale of what are widely considered natural or Indian ayurvedic and homeopathic remedies for diabetes. It cracked down on 15 companies’ dietary supplements for diabetes, saying the therapies don’t work, can be dangerous and, in some cases, include undisclosed prescription drugs.
The FDA sent letters on Tuesday asking for written responses from each of the companies within 15 business days, saying that failure to correct the violations could result in criminal prosecution.
It’s not uncommon for diabetes patients to look for alternative remedies, but the FDA is clearly skeptical of ayurvedic products and what it describes as “medicine of the healing arts that originated in India.”
“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments,” said FDA Commissioner Margaret A. Hamburg.
“Consumers who buy violative products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management.”
FDA officials noted three of the most potentially harmful “natural” supplements originated from Asia and contained pharmaceutical ingredients that were not disclosed on the product labels. It said Diexi, marketed as a natural herbal formula from Surat-based Amrutam Life Care in India actually contained the diabetes drug metformin.
“Undeclared ingredients can cause serious harm,” said the FDA which tested products marketed as “all natural” treatments for diabetes. It discovered some of them contained ingredients found in prescription drugs to treat Type 2 diabetes.
FDA explained that if consumers are unaware of the actual ingredients in the products they are taking, these products may interact in dangerous ways with other medications. One possible complication is that patients may end up taking a larger combined dose of the diabetic drugs than they intended, which may cause hypoglycemia.
Amrutam was also cited for tall claims with regards to supplements such as Zoom (for erectile dysfunction), Arexi (for arthritis) Allexi (for allergy), Cholexi (for cholesterol control), and Obexi (for obesity).
“By marketing your products Diexi and Zoom as ‘all-natural,’ ‘safe and effective’ treatments with ‘no chemically generated compounds,’ consumers are misled to believe your products do not bear unknown risks nor contain APIs found in approved prescription drugs. Accordingly, the failure to disclose the presence of metformin and sildenafil renders these products’ labeling false and misleading,” the FDA said in its letter to Amrutam.
In some products the FDA found Jiang Tan Yi Huo Su Jiao Nang, a Chinese remedy found to contain metformin and glyburide as well as phenformin, a substance pulled from the market in the US in 1978 because it had been linked to a condition known as lactic acidosis.
The agency said they aren’t currently aware of any injuries or illnesses linked to the offending products, but said they are acting in order to protect Americans from potential harm linked to the substances.
Over 25 million Americans have diabetes and 60 million Indians also suffer from the condition, in which a patient’s blood glucose or blood sugar levels are high as a result of the body’s inability to produce or effectively utilize insulin. If the disease is not managed properly, there is an increased risk for heart disease, blindness, kidney failure, lower-extremity amputations or other serious medical complications, the FDA warned.
Several Indian drug manufacturers like Ranbaxy Laboratories, Jubilant Life Sciences and Sun Pharmaceuticals Industries have faced compliance issues over the past three to four years, mainly after FDA investigations.
Wockhardt shares have fallen 25.8 percent so far this week, wiping 25.1 billion rupees from its market value, after a warning from the FDA about subpar manufacturing practices at its Waluj plant. Wockhardt has previously said the US ban would cost it about $100 million in sales a year.
Meanwhile, the FDA said menthol cigarettes likely pose a greater public health risk than regular cigarettes based on the result of an independent review released Tuesday. The FDA said menthol cigarettes appeals to younger smokers and is likely associated with greater addiction.