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FDA Must Stop Manufacturers’ Off-Label Promotion of Dangerous Diabetes Medications

March 31, 2015

FDA Must Stop Manufacturers’ Off-Label Promotion of Dangerous Diabetes Medications

Drugs Are Being Promoted for Weight Loss and High Blood Pressure But FDA Never Deemed Them Safe or Effective for Either

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several dangerous diabetes medications for weight loss or blood pressure reduction, two uses that have never been approved by the FDA, Public Citizen wrote in a letter today to the agency’s Office of Prescription Drug Promotion.

The drugs are Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release exenatide).

The FDA has never deemed any of the five medications safe or effective for either use, and low blood pressure is a major side effect of the two drugs (Farxiga and Invokana) promoted for this use. Other side effects of the five drugs include urinary tract infections, yeast infections (Farxiga, Jardiance and Invokana), bladder cancer (Farxiga), pancreatitis, thyroid C-cell tumors (Victoza and Bydureon) and kidney failure (all five drugs).

By inflating the drugs’ perceived benefits, the advertisements dangerously skew the risk-benefit calculations made by physicians and patients toward deciding to initiate or continue these therapies. This is especially likely to occur with a weight-loss claim targeted at overweight and obese Type 2 diabetics struggling with both their disease and their weight.

Public Citizen is calling on the FDA to issue warning letters requiring the manufacturers to withdraw these and any other advertisements containing similar off-label promotional statements. The FDA’s issuance of such letters has fallen sharply in recent years, from an average of 111 such letters sent per year from 1997-2001, to just 29 per year from 2010-2014.

In addition, the FDA has never fined a pharmaceutical company for unlawfully misleading drug ads, despite having the authority to do so since the 2007 Food and Drug Administration Amendments Act. Therefore, to more effectively deter future ads that violate FDA rules, Public Citizen also is calling on the agency to fine the companies involved in the off-label marketing of the five diabetes drugs.

“The FDA is clearly asleep at the wheel in regulating the marketing of often dangerous pharmaceuticals to the public,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “When companies can engage in such off-label promotion with no consequences, it virtually guarantees that such marketing to patients and physicians alike will continue unabated. This undermines the vital drug approval process, with companies finding little need to conduct rigorous studies for FDA approval of additional uses when they can just market their drugs for any lucrative use they see fit.”

View the letter, which includes images of the ads.