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FDA Issues Strong Labeling Changes for Opioids and Benzodiazepines

by Madhumathi Palaniappan on September 19, 2016 at 10:48 AM
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FDA Issues Strong Labeling Changes for Opioids and Benzodiazepines

The United States Food and Drug Administration has recently issued labeling changes, boxed warnings, patient information to healthcare providers and patient care regarding the use of opioids and benzodiazepines.

Opioids are analgesic drugs used in reducing pain and cough. Prescription drugs like oxycodone, morphine and hydrocodone are used for the treatment of cough. Benzodiazepines are used in the treatment of neurological conditions like anxiety, insomnia and seizure disorders.

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After receiving citizen petitions from numerous public and health care officials for concomitant use of opioids and benzodiazepines, the FDA has inititated review for safety informations on the combined use of opioids with benzodiazepines.

FDA requires boxed warnings and medication guides for about 400 opioid and benzodiazepine drugs. These drugs must have their serious side effects and risks mentioned in the warnings which includes sleepiness, respiratory depression, coma and death.
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Robert Califf, M.D., FDA commissioner said that, "It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,"

"We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines - or CNS depressants more generally - together outweigh these serious risks." he added.

According to a data reviewed by the FDA from 2004 - 2011, the use of opioids and benzodiazepine drugs without prescriptions has increased over the period and the number of overdose deaths were found to be tripled.

More than 2.5 million people were found to be taking benzodiazepines with opioid analgesics. The Clinical Guidelines of the U.S. Center for Disease Control and Prevention has also cautioned about the combined use of opioids with benzodiazepines along with FDA.

The warnings must be taken seriously to reduce opioid misuse and abuse and proper care should be initiated for safe use of the drugs.



Source: Medindia
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