- Hetlioz (tasimeltion), intended for treatment of non-24 hour sleep-wake disorder, was mislabeled by the FDA—twice.
- Non-24 hour sleep-wake disorder is a condition in which the body's clock is thrown off, leading to sleep problems. Approximately 100,000 blind people are affected by this disorder.
- When Hetlioz was approved in early 2014, the label did not include language that the drug should be used in people who are blind. As a result, the label was unintentionally broadened. When the agency became aware of the problem, they re-issued an approval letter, but they reiterated the incorrect labeling in the letter. The label is still incorrect.
According to the National Sleep Foundation (NSF), non-24 sleep-wake disorder is a circadian disorder in which a person's sleep-wake cycle is not synchronized with the 24-hour day-night cycle. Moreover, the NSF estimates that up to 75% of the 1.3 million blind people in the United States may have this disorder, owing partly to a complete lack of light perception, which makes it difficult for them to regulate their circadian clock.
However, according to a Citizen's Petition, the FDA has inadvertently broadened the label by omitting blindness from the indication. And considering the fact that up to 70 million people in the U.S. have some type of sleep disorder that could translate into a much larger treatment population than originally intended.
In addition, Public Citizen contends that Vanda did not conduct trials in people who were not blind, therefore there is no efficacy/safety database in this population---meaining it could potentially be dangerous. According to the label, side effects associated with Hetlioz include headace, elevated liver enzymes, nightmares, respiratory infectons, nightmares and drowsiness.
Public Citizen asserts that by not changing the label, the FDA is putting patients at risk.