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…

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