FDA Warns Vanda Over Misleading Nereus TV Ad

FDA has issued Vanda Pharmaceuticals an untitled letter citing a television advertisement for its motion sickness drug Nereus (tradipitant), alleging that a high-speed car chase and other dramatic scenes misleadingly portray the drug's effectiveness and safety while interfering with viewers' understanding of its risks. The agency said it received complaints about the advertisement through its Bad Ad Program.

The just-posted 10/26 letter from CDER's Office of Prescription Drug Promotion (OPDP) says the advertisement falsely suggests that Nereus can prevent vomiting almost immediately after administration, despite labeling recommending that the drug be taken about 60 minutes before activities expected to cause motion-induced vomiting.

The TV ad depicts a man driving a white convertible in a high-speed pursuit involving skidding, swerving and airborne vehicles. After stopping on a bridge, the driver takes a capsule apparently representing Nereus, jumps into a motorboat and speeds away.

FDA said the depiction creates the misleading impression that Nereus can be taken after exposure to motion or immediately before an activity that could cause vomiting. The agency noted that the drug has not been evaluated for treating established nausea and vomiting.

OPDP also objected to the ad’s depiction of extreme driving because Nereus labeling warns that the drug may impair the mental or physical abilities needed to operate motor vehicles or heavy machinery. FDA said a spoken and written warning about impaired driving did not adequately counteract the misleading visuals.

The agency identified additional violations involving the presentation of safety information. During 31 seconds of risk disclosures, the ad used 11 dynamic scene changes, including high-speed driving footage, that FDA said compete for viewers' attention and interfere with comprehension.

Additionally, FDA found that the ad failed to comply with requirements for simultaneous audio and text presentation of major risks because some on-screen information did not correspond to the spoken disclosures.