WASHINGTON, D.C. (WPVI) -- The Food and Drug Administration today announced that several insomnia drugs, including the big-seller Ambien, must carry black box warnings, because of rare but serious incidents.
Black box warnings are the FDA's most prominent warning.
The move was made after reports of serious injuries and deaths from sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove.
The new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).
"These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses," said FDA Acting Commissioner Ned Sharpless, M.D.
In addition to the boxed warning, the agency is requiring the addition of a contraindication to not use these medicines in patients who have experienced an episode of complex sleep behaviors after taking them.
The FDA reviewed 66 cases reported to the FDA Adverse Event Reporting System or found in medical literature, in which patients engaged in activities while they were not fully awake.
The 46 reports of non-fatal serious injuries included accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds and apparent suicide attempts.
The 20 deaths reported were from carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving and apparent suicide.
The US Food and Drug Administration (FDA) approved glecaprevir and pibrentasvir (Mavyret, AbbVie) tablets for the treatment of all six hepatitis C virus (HCV) genotypes in children ages 12 to 17 years.
The drug combination was approved for adults 2 years ago.
"Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection," says Dr. Jeffrey Murray of the FDA.
"Today's approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV," he added.
All patients (100%) who received the drug combination for 8 or 16 weeks had undetectable virus in the blood 12 weeks after completing treatment, "suggesting that patients' infection had been cured," according to an FDA news release.
The most frequent adverse reactions to those taking the drugs were headache and fatigue.
The drug combo shouldn't be taken by those taking the medications atazanavir and rifampin.