Caring for multiple health issues can be difficult, and for the more than 85 percent of diabetics who are overweight, it may seem like it’s impossible to get ahead. A diabetes pill that could maintain blood sugar and simultaneously aid in weight loss might appear to be the perfect fix—especially when it’s presented that way in Invokana advertisements.
Diabetes and obesity are closely tied, creating a new trend in advertising strategies for pharmaceutical treatments. Invokana ads boasting blood pressure reduction and weight loss, in addition to type A1 management, are becoming increasingly common.
But the Food and Drug Administration (FDA) didn’t approve diabetes medications to manage weight and blood pressure. And because many diabetes drugs come with dangerous side effects, consumer groups are fighting back.
Public Citizen, a 350,000 member organization spearheading a number of campaigns against drug dangers, urged the FDA’s Office of Prescription Drug Promotion to police pharmaceutical companies overstepping their commercial boundaries. On March 31, 2015, the group penned a letter to the Food and Drug Administration (FDA) to call attention to these violations.
Despite having no approval from the FDA, manufacturers place misleading ads on their websites and in magazines. The organization has asked the agency to put a stop to off-label marketing of five drugs, including:
- Invokana (canagliflozin)
- Farxiga (dapagliflozin)
- Jardiance (empagliflozin)
- Victoza (liraglutide)
- Bydureon (extended-release exenatide)
When drugs are taken for unapproved uses, it can lead to a number of side effects. Many of these drugs are linked to urinary tract infections, bladder cancer, pancreatitis, yeast infections, thyroid c-cell tumors, and kidney failure.
“In the case of Farxiga and Invokana, blood pressure reduction also is touted as a potential benefit,” Public Citizen wrote in the complaint. “This is an especially egregious ‘benefit’ claim, as hypotension is listed as an adverse effect in the medications’ labels, owing to the diuretic effect and possible volume depletion inherent in the drugs’ mechanism of action.”
Public Citizen reminded the FDA of its responsibility to maintain the legitimacy of a highly competitive and commercialized drug market. The organization said the misleading Invokana ads are particularly dangerous because they influence patient decision-making and undermine the FDA approval process.
In the letter, Public Citizen pointed out that the FDA’s advertising regulations significantly decreased in recent years. Only ten warning letters were issued to pharmaceutical companies for advertising violations, which is the fewest number since at least 1997.
Public Citizen has asked the FDA to fine the companies involved in the off-label marketing of the five diabetes drugs. In 2007, the Food and Drug Administration Amendments Act gave the FDA the authority to fine pharmaceutical companies for unlawful promotion. The agency has yet to exercise its right to apply this penalty.
Dr. Sammy Almashat, a researcher with Public Citizen’s Health Research Group, said that off-label promotion comes with consequences. When regulatory agencies allow unrestricted drug marketing, it gives manufacturers the go-ahead to make misleading or inaccurate claims.
“The FDA is clearly asleep at the wheel in regulating the marketing of often dangerous pharmaceuticals to the public,” Almashat said in a statement.
Because unchecked drug endorsements could endanger the public, the group asserts that a financial repercussion will be more effective in deterring unlawful ads in the future.