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FDA: Sleep meds require new 'black box' warnings

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Federal health officials will require drug makers of popular sleeping pills to add new warning labels to certain prescription insomnia medications after reviewing cases of dangerous, sometimes fatal, incidents tied to the drugs.

New "black box" warning labels will be required for brand name drugs including Lunesta, Sonata and Ambien, among others, to caution patients about their possible side effects, the Food and Drug Administration announced Tuesday.

"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 Dr. 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."

When reviewing cases reported to health officials and found in medical literature, the FDA found 66 incidents in which a patient taking insomnia medicines eszopiclone, zaleplon, or zolpidem did things like sleepwalk or drive that resulted in injury or even death.

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1 Comments Sort By
LeeMay 10 months ago

Black box warnings should be for ALL of of these poisonous prescriptions.

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