Consumer Advocates Concerned that Hetlioz non-24 Disorder Drug may not be Safe for Some Users, Petitions FDA to Change the Medication’s Label

The consumer advocacy group Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to change the labeling on the drug Hetlioz to reflect that the medication is only approved to treat “non-24 sleep-wake disorder,” which affects people who are totally blind.

The Hetlioz label does not specify that the drug is intended only for those with the rare condition who are completely blind. The disorder throws off the internal body clock and causes sleeping problems. The vast majority of people who have the disorder are, in fact, totally blind. Public Citizen says the FDA realized the mistake sometime last year, but did not revise the drug’s product labeling. Instead, the agency issued a second approval letter stating that the first approval letter contained an error about the approved use of the drug. The FDA also changed the description of the approved use of Hetlioz to match the incorrect product labeling, according to The Wall Street Journal (WSJ).

In the petition, Public Citizen calls on the FDA to specify on the drug’s label that Metlioz is intended only for use in patients who are completely blind. The group says that leaving the mistake uncorrected could widen the market for the drug, and claims that there is not enough evidence to show that Hetlioz is safe and effective for people who have non-24 and are not blind. This violates the legal standard required for drug approval, the group says, because the drug’s maker, Vanda Pharmaceuticals, only applied to market the product to people with non-24 who are blind. In addition, Public Citizen says the drug’s labeling should include data concerning toxic effects observed in animal studies, since it was originally omitted. The group believes health regulators should ask Vanda to run a safety trial of Hetlioz, as well, WSJ reported.

An FDA spokeswoman wrote WSJ and said that the agency will review the petition and reply directly to Public Citizen.

“The actions taken by the FDA in response to the original mistake in approving [the] erroneous label are unacceptable and deeply disturbing,” says Michael Carome, who heads Public Citizen’s Health Research in a statement to WSJ. “Because of its failures in this matter, the FDA has allowed a potentially dangerous medication to be given to people for whom there is a lack of substantial evidence that it is safe and effective.”

“The FDA’s retroactive decision to expand the approved indication… to non-blind individuals, rather than correct the agency’s embarrassing mistake in approving a drug label that had an incorrect indication, represents an unprecedented and disturbing failure on the part of the agency,” he continues. “As a matter of principle, this inappropriate action by the FDA must not be allowed to stand.”

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