(U.S.) FDA Requiring New Boxed Warnings About Serious Risks and Death
August 31, 2016
ISSUE: FDA review has found that the growing
combined use of opioid medicines with benzodiazepines or other drugs
that depress the central nervous system (CNS) has resulted in serious
side effects, including slowed or difficult breathing and deaths.
Opioids are used to treat pain and cough; benzodiazepines are used to
treat anxiety, insomnia, and seizures. In an effort to decrease the use
of opioids and benzodiazepines, or opioids and other CNS depressants,
together, FDA is adding Boxed Warnings, our strongest warnings, to the
drug labeling of prescription opioid pain and prescription opioid cough
medicines, and benzodiazepines. See the Drug Safety Communication for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.
FDA
conducted and reviewed several studies showing that serious risks are
associated with the combined use of opioids and benzodiazepines, other
drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication for a Data Summary).......
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(list) Drugs that contain benzodiazepines
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