Consumer Group Concerned Over Off-Label Marketing of Invokana

Washington, DCIt was back in March that the noted consumer advocacy group Public Citizen petitioned the US Food and Drug Administration (FDA) over allegations of off-label promotion of indications for which Invokana, and other drugs, were never originally and formally approved by the US drug regulator.

Headlines suggesting “Invokana Linked with Cardiovascular Injuries and Kidney Failure” are bad enough for those patients who are prescribed drugs such as Invokana for their diabetes, the indication for which Invokana has been approved in spite of risks. Drugs such as Invokana have known Invokana side effects that could either be minimal or severe - but provided the benefits for the drug outweigh the risks for the intended patients, the drugs are deemed to be safe based on a positive risk/benefit profile as noted above.

Doctors have always had the medical and legal authority to prescribe drugs for indications that do not carry FDA approval provided, in their professional opinion, the drug would benefit the patient. In this way, physicians can circumvent the FDA.

Manufacturers, however, do not possess that authority and are prevented from marketing drugs off-label to doctors or directly to patients.

This is where Public Citizen comes in. Having identified some allegedly questionable marketing practices, the consumer advocacy group fired off a letter to the FDA protesting a series of direct-to-consumer adverts that appear to promote Invokana and a handful of others as having benefits for weight loss, and for those suffering from high blood pressure.

“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.”

Public Citizen noted the FDA has possessed the authority to levy fines against manufacturers for marketing their products off-label since 2007, but has yet to censure a manufacturer in this way. Additionally, the advocacy group notes that cease-and-desist letters to manufacturers and marketers from the FDA have fallen sharply in recent years.

References to weight loss and the benefit for lower blood pressure were not presented as a direct promise - more of an aside - but the reference was there nonetheless, with Public Citizen submitting examples of the offending marketing materials in their communiqué to the FDA.

High blood pressure and excessive weight are amongst the major health frustrations experienced by a large cross section of the American population - those who may view drugs like Invokana, regardless of the presence of diabetes, as a new tool for fighting the battle of the bulge or reining in high blood pressure.

The problem, notes Public Citizen, is that Invokana for type 2 diabetes was never deemed by the FDA as safe and effective for either indication. Low blood pressure is already a major side effect amongst Invokana adverse events. Other Invokana side effects identified by Public Citizen include urinary tract and yeast infection, and kidney failure.

By promoting - even subtly - the potential advantages of Invokana for high blood pressure and excess weight, more Americans might be exposed to a drug and related side effects needlessly.

Two of the other drugs identified by Public Citizen are Jardiance (empagliflozin) and Farxiga (dapagliflozin). All three identified above can be associated with kidney failure as well as urinary tract infections and yeast infections. Farxiga has also been linked to bladder cancer.

Public Citizen has petitioned the FDA to have so-called “added-value” adverts stopped. Type 2 diabetes medications such as Invokana should only be promoted for the indication approved by the FDA and nothing else.