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The Food and Drug Administration has warned for years of possible side effects of taking sleeping pills and this week, federal health officials have issued their strongest warning to date.
On Tuesday, the FDA announced that it had ordered drug manufacturers using prescription drugs against insomnia to add "black box" warning labels – the only one it had been. The agency's most important warning – to warn patients of their dangers, after an investigation had revealed cases of serious or even fatal injuries, from various "complex behaviors" related to drugs. These behaviors included sleepwalking, drowsy driving, and "participating in other activities without being fully awake, such as using a stove in an unsafe manner," the FDA said.
All sleep aids do not pose these risks, the FDA noted.
The new warnings will be needed for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist). Although the labels of these drugs already include a warning, the FDA said the new "black box" warning was meant to emphasize the seriousness of the risk of injury or death when using these products.
"We recognize that millions of Americans suffer from insomnia and rely on these medications to help them sleep better at night," said Acting FDA Commissioner Dr. Ned Sharpless in a statement. Press. "Although these incidents are rare, they are serious and it is important for patients and health professionals to be aware of the risk, which may occur after the first dose of these sleeping pills or after a longer period of treatment, and can occur in patients without a history of these behaviors and even at the lowest recommended doses. "
The FDA investigated 66 cases reported to health officials and identified in medical publications in which patients engaged in activities such as sleepwalking or driving while causing serious injury or death after taking either Eszopiclone, zaleplon or zolpidem.
In 46 of the cases reviewed by the agency, patients sustained non-fatal serious injuries, including "accidental overdoses, falls, burns, near drowning, gunshot wounds, and apparent suicide attempts. The 20 reported deaths were due to drowning, fatal falls, carbon monoxide poisoning, apparent suicide and fatal collisions between a vehicle and its driver.
The FDA added that a contraindication was also required, advising people who had previously had complex sleep behavior to stop using these drugs.
"We have been closely monitoring the safety profile of these drugs since their approval, when our ongoing surveillance on safety recently revealed the risk of more serious injuries and deaths in patients taking these medications and who behaved differently. In complex sleep, we determined that stronger measures were needed to inform the public, "said Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research. "We will continue to monitor and evaluate these risks associated with insomnia medications and to communicate with the public or consider other measures as appropriate."
According to the FDA, approximately 30 million prescriptions of the three drugs were dispensed in the United States in 2018.
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