FDA Requires New Labeling On Drugs, Warns Of Combining Opioids And Benzodiazepines

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FDA Requires New Labeling On Drugs, Warns Of Combining Opioids And Benzodiazepines

According to the Food and Drug Administration, prescription opioids and benzodiazepines are to be labeled with a serious warning about potential side effects and the possibility of overdose when used in combination.

These warnings encourage health care professional to only administer prescriptions for opioids with benzodiazepines (anti-anxiety medication such as Xanax) and other central nervous system depressants to patients who cannot garner effective treatment from alternative therapies. They also urge to limit dosages and duration of treatment to the minimum possible time to obtain the desired therapeutic clinical outcome.

FDA deputy director for Center for Drug Evaluation and Research states that the FDA is requiring companies to update their product labeling for opioids and benzodiazepines with warnings, as well as “new or updated medication guides for these drugs reflecting those same warnings.”

Opioid labels will warn against prescribing the drug in conjunction with benzodiazepines and other central nervous system depressants. Conversely, benzodiazepine labels will warn against prescribing the drugs in combination with opioids. The FDA has also issued a warning to the public about the risk of using these drugs in combination.

Why The Concern?

opioids and benzodiazepines | Just Believe RecoveryThe use of multiple central nervous system (CNS) depressants significantly increases the risk of a life-threatening overdose. CNS depressants include prescription opioids, opiates, benzodiazepines, muscle relaxers, anti-psychotics, hypnotics, sedatives, anti-depressants, and alcohol.

The inserted graph from the National Center for Health Statistics shows the number of fatalities related to benzodiazepines, with (the red line) and without (the purple line) opioids.

From 2002 to 2015, benzodiazepine fatalities involving opioids increased two-fold more than those that did not involve opioids.

This action is one of many included in the FDA’s Opioids Action Plan. The FDA states that the administration will “continue to monitor these products and carefully and take additional actions as needed, and will share updates with the public as necessary…to address this public health crisis.”

~ G. Nathalee Serrels, M.A., Psychology

References

https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates

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