FDA Now Requires Black Box Warnings For Combined Use Of Opioids And Benzodiazepines

162017_132140396847214_292624_nOn August 31, 2016, the FDA announced new warning requirements regarding the combined use (same time use) of opioids and benzodiazepines, including black box warnings (the highest level of warning) for the serious risks that include extreme sleepiness, respiratory depression, coma, and death. The new warning requirements affect nearly 400 products.

In Maryland, there were 351 opioid-related deaths and 91 benzodiazepine-related deaths reported last year. The FDA Commissioner of food and drugs stated in announcing the new warnings, “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.”

What Are Opioids?

According to the FDA, opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone, and morphine, among other drugs, under both brand and generic names. Certain other opioid medications are also approved to treat a cough. Opioid analgesic misuse and abuse have increased significantly in the United States over the past two decades and represent major public health concerns due to the risk of coma and fatal respiratory depression associated with opioid analgesic overdose.

What Are Benzodiazepines?

According to the FDA, benzodiazepines are drugs typically prescribed for the treatment of neurological and/or psychological conditions, including anxiety, insomnia, and seizure disorders.

Both opioids and benzodiazepines depress the central nervous system (“CNS depressants”). However, both classes of drugs have unique pharmacology, safety risks, and labeling information related to its use. Therefore, the FDA is requiring opioid analgesics, prescription opioid cough products, and benzodiazepines to have slightly different labeling.

Why Is The FDA Requiring The New Warnings Now?

The FDA reviewed data that showed that physicians have been increasingly prescribing opioids and benzodiazepines together, which has been associated with adverse outcomes: from 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths (from taking prescribed or greater than prescribed doses) involving both drug classes nearly tripling during that period. The FDA data also showed that the number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41% between 2002 and 2014, which means an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.

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If you or a loved one were injured (or worse) due to use of an opioid, a benzodiazepine, a combination of opioids and benzodiazepines, a prescription drug error, a dispensing error, a dosing error, a counterfeit drug, or a bad drug, you should promptly seek the legal advice of a drug claim attorney in your U.S. state who may investigate your drug claim for you and represent you in a drug claim case and/or a medication malpractice case, if appropriate.

Visit our website to be connected with drug claim lawyers in your state who may assist you, or call us toll-free in the United States at 800-295-3959.

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This entry was posted on Tuesday, September 6th, 2016 at 5:17 am. Both comments and pings are currently closed.

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