Invokana Amputation Lawsuits Cite Consumer Advertising

Trenton, NJThe pleasant-looking man looks into the camera and tells us that taking Invokana “may also help you lose a little weight.” Big problem. The FDA has not approved Invokana for weight-loss. The drug has had a rocky history since its approval in 2013, and a recent FDA warning cites the danger of Invokana leg and foot amputations. Direct-to-consumer drug advertising can magnify the harm that dangerous drugs do to patients who may spend more time listening to that friendly man (or his commercial kin) than they do talking with their own doctors.

Increasing red flags
In September 2015, the FDA linked Invokana to premature bone loss and fractures. In December 2015, the FDA announced that Invokana caused diabetic ketoacidosis, pyelonephritis (kidney infections), and urosepsis. In March 2016, the FDA added severe renal impairment, angioedema, and anaphylaxis. In May 2016, the FDA announced that Invokana was linked to an increased risk of lower extremity amputations.

In the meantime, by December 2016, multiple lawsuits had been consolidated into Invokana multidistrict litigation in the District of New Jersey. That litigation has only grown and become more complicated with the new amputation lawsuits. Recent Invokana lawsuits have specifically called out J&J’s consumer marketing drive.

Where is the FDA when it comes to DTC advertising?
In theory, the FDA regulates direct-to-consumer pharmaceutical advertising in order to prevent false, misleading or deceptively incomplete claims. Those regulations were relaxed in 1997, and DTC advertising has since exploded. Pharmaceutical companies are still specifically prohibited from marketing drugs for off-label use, however. Invokana is not approved for weight-loss, so the violation seems obvious.

In 2015, long before the Invokana amputation warnings, Public Citizen, a consumer advocacy group, raised the alarm about J&J’s aggressive consumer marketing activities, urging the FDA to stop “the apparently violative off-label promotional statements in the direct-to-consumer (DTC) advertisements of five prescription drugs approved for the treatment of Type 2 diabetes. The drugs are Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended release exenatide).”

Several years have passed – and nothing so far.

The pernicious power of repetition
In a statistic quoted by the journal Pharmacy and Therapeutics, “The average American TV viewer watches as many as nine drug ads a day, totaling 16 hours per year, which far exceeds the amount of time the average individual spends with a primary care physician.” Pharmaceutical marketing is a form of labeling, which the FDA has the power and responsibility to regulate. Aggressive off- label consumer marketing may exacerbate the harm that that defective or inadequately tested drugs do to patients who trust their doctors and health care regulators with their well-being.