Pharmaceutical company Boehringer Ingelheim has introduced a new Pradaxa reversal agent, marketing the drug with a series of ads that feature a computer-animated school of red fish.

The new drug is Praxbind, designed to reverse the blood-thinning effect of the anticoagulant Pradaxa. Pradaxa was originally released in 2010 as one of a new class of anticoagulants that would compete with the much older and well-established drug warfarin.

However, Pradaxa was introduced to the market without any available antidote that could counter its anticoagulant effect. This lack of a Pradaxa reversal agent allowed warfarin to retain at least one practical advantage over Pradaxa, since warfarin’s anticoagulant effect could be reversed by administering vitamin K.

A New Campaign for a New Pradaxa Reversal Agent

The new ad campaign uses computer-animated red fish to represent blood cells as they flow through blood vessels. The ads highlight the new availability of Praxbind. The ad also illustrates how atrial fibrillation creates a risk of blood clot-related conditions like stroke, and how Pradaxa works to reduce that risk.

Praxbind was approved by the FDA in October 2015. Approval was granted on an accelerated basis so that Praxbind could be used in emergencies when excessive bleeding needs to be stopped. Praxbind is the first Pradaxa reversal agent to be approved. It works by binding the Pradaxa compound, neutralizing its effect.

The accelerated approval process will require Boehringer Ingelheim to follow up with additional clinical information to confirm Praxbind’s clinical effect.

Since Boerhinger’s ad campaign was launched in January 2016, the FDA has announced plans for a new study of pharmaceutical marketing that uses animated characters and how that marketing affects consumer’s behavior.

The agency says it plans to examine how the use of animation affects consumers’ perceptions of the risks and benefits associated with the drug being advertised.

According to the FDA’s announcement, animated characters can “grab attention, increase ad memorability, and enhance persuasion to ultimately drive behavior.” The announcement notes that animation can create positive feelings in the viewer, feelings that could then be transferred to the advertised drug.

The FDA is concerned that this phenomenon may skew consumer’s impression of the drug’s safety profile, or may lower the perceived risks associated with side effects.

Pradaxa Lawsuits

Excessive bleeding is a risk common to all anticoagulants, not just Pradaxa. The lack of a Pradaxa reversal agent has been raised by some plaintiffs in a wave of thousands of Pradaxa lawsuits as evidence that Boehringer Ingelheim mishandled its release of Pradaxa onto the market.

The plaintiffs in these Pradaxa lawsuits generally allege that Pradaxa caused them or a close relative to suffer excessive bleeding that was in some cases life-threatening or even fatal.

Some argue that Boehringer Ingelheim’s disregarded patient safety with its aggressive marketing campaigns. They argue the company failed to properly disclose the risks associated with Pradaxa and, until a Pradaxa reversal agent was finally released, failed to provide an adequate treatment for excessive Pradaxa bleeding.

In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle about 4,000 state and federal Pradaxa lawsuits. The settlement did not require the company to admit to any liability, however.