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Petition: FDA-Approved Tasimelteon Label Must Be Corrected
In June, Public Citizen petitioned the Food and Drug Administration (FDA) to immediately correct the label of the sleep drug tasimelteon (HETLIOZ) to restrict its use to patients who are totally blind.[1] Before its approval in January 2014, the drug had been studied in, and originally intended for, only totally blind patients with a rare sleep disorder known as non-24-hour sleep-wake disorder, or non-24. However, the FDA...
Petition: FDA-Approved Tasimelteon Label Must Be Corrected
In June, Public Citizen petitioned the Food and Drug Administration (FDA) to immediately correct the label of the sleep drug tasimelteon (HETLIOZ) to restrict its use to patients who are totally blind.[1] Before its approval in January 2014, the drug had been studied in, and originally intended for, only totally blind patients with a rare sleep disorder known as non-24-hour sleep-wake disorder, or non-24. However, the FDA mistakenly approved a label that expanded the drug’s use to nonblind patients with non-24, a population for whom tasimelteon had not been proven safe and effective. Upon realizing the oversight, the FDA unfortunately opted to issue a second approval letter retroactively affirming the expanded use, instead of simply correcting the label. In addition to asking for a label correction, Public Citizen's petition requested that certain warnings be added to the label and that a large clinical trial be conducted to glean more information on tasimelteon’s risks.
References
[1] Public Citizen. Petition to FDA Concerning the Inappropriately Expanded Approval of the Sleep Drug Tasimelteon (Hetlioz). June 11, 2015. http://www.citizen.org/hrg2265. Accessed September 28, 2015.
