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Many Americans take sleeping pills for their insomnia, but now the FDA requires stronger warnings for certain medications. During specific incidents, the side effects were so severe that they resulted in death. ( Bruno Glätsch | pixabay )
The FDA has slapped a number of prescription insomnia medications with a new boxed warning, known to be the most important warning of the agency.
The new warning will concern specific drugs, including eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist).
In the official announcement, the FDA revealed that the move was responding to several cases of serious injury and death resulting from various complex sleep behaviors that occurred after taking the pill. Behaviors range from sleepwalking to drowsy driving and other potentially dangerous activities.
The FDA issues a warning 'Black Box & # 39; for insomnia medications
"These incidents may occur after the first dose of these sleeping pills or after a longer period of treatment, and may occur in patients with no history of these behaviors and even at the lowest recommended doses," said the acting commissioner of the FDA, Ned Sharpless, MD. adding that serious incidents are rare, but it is extremely important for physicians and patients to be aware of the different risks that can occur when taking these medications.
In addition to the warning, the FDA also requires the contraindication that tells patients to stop using an insomnia medication after having an episode of complex sleep behavior after having it. taken.
Janet Woodbad, Director of the Agency's Center for Drug Evaluation and Research, explained that officials have been monitoring and monitoring the safety profile of these prescription drugs since their approval.
"When our ongoing surveillance of safety recently highlighted the risk of more serious injuries and deaths among patients taking these medications who exhibited complex sleep behaviors, we determined that it was necessary to take action stricter to inform the public, "said Woodbad, adding that the team plans to continue its monitoring and evaluation activities to make the necessary changes.
Although these medications already include a label indicating their badociations with complex sleep behaviors, the new warnings and contraindications provided are intended to make them more visible and to communicate potentially serious and fatal risks.
Serious risks badociated with taking medication for insomnia
The FDA has identified 66 cases of patients in the last 26 years who took these insomnia medications and then sustained serious injury or death without being fully awake, according to a CNN report.
There were 46 non-fatal injuries of varying severity. Incidents included accidental overdoses, burns, near-drowning, falls, limb loss due to exposure to extreme temperatures, gunshot wounds, and even suicide attempts.
In total, 20 deaths occurred for various reasons, including carbon monoxide poisoning, drowning, falls, hypothermia, road accidents and suicide.
In 2012, an article published in the Primary Care Companion for CNS Disorders detailed two cases of people killing their spouses under the influence of zolpidem. In both cases, the people involved had no case of previous aggressive behavior.
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