The FDA will require drugmakers of popular sleeping pills to add warning labels after reports of injury and death in patients who took the drugs.
Federal health officials will require drugmakers of popular sleeping pills to add warning labels to certain prescription insomnia medications after reviewing cases of dangerous, sometimes fatal, incidents tied to the drugs.
"While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk," acting FDA Commissioner Ned Sharpless said in a statement."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.
The 46 nonfatal cases that caused serious injury 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.
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