The drug Hetlioz was approved last year for the treatment of a disorder that affects blind people known as “non-24 sleep-wake disorder.” One consumer advocacy group says the U.S. Food and Drug Administration (FDA) made a mistake on the drug’s label and inadvertently widened the market for the drug.
Non-24 is a rare condition that throws off the internal body clock and causes sleeping problems. The disorder only affects people who are completely blind. The FDA became aware of the mistake last year, but instead of revising the Hetlioz product labeling, the agency issued a second approval letter. The second letter stated that the first letter contained an error about the approved use of the drug, and went on to change the description of the approved use to match the incorrect product labeling, The Wall Street Journal (WSJ) reported. More Mislabeling of Non-24 Sleep Disorder Drug May Encourage Off-Label Use, Advocacy Group Warns