FDA Demands Warnings For Opioid Painkillers And Benzodiazepines


Facing a massive uptick in fatal overdoses caused by the dual use of , the FDA announced yesterday that it would demand that pharmaceutical companies begin issuing “boxed warnings” –the strongest FDA warning– on nearly 400 drugs warning of the danger of the two classes of drugs taken at the same time.


Drug overdoses reaching near epidemic levels, FDA

The over-prescribing of opioid painkillers like Oxycontin has reached levels in the United States that can only be called reckless. Given this maleficence by doctors coast-to-coast, the United States has seen a level of fatal drug overdoses that is nothing short of staggering. Drug overdoses along with suicide and liver disease have seen life expectancy numbers in the United States drop for the first time since 1993 and that, quite simply, was during the height of the AIDS epidemic.

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“There is the expectation that life expectancy will go up every year, and that has been realized just about every year over the past century,” said Samuel Preston, a demographer at the University of Pennsylvania.

That chapter has closed and while suicide and liver disease are contributing factors drug overdoses are most to blame.

Specifically, combining opioid painkillers and benzodiazepines are killing scores of people each month. Without listing every drug in these categories, just trust that by taking Oxycontin and Xanax together you run the serious risk of extreme sleepiness, respiratory depression, coma and death.

This understanding prompted the FDA to require the “boxed warnings” announced yesterday.

“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,” said Dr. Robert Califf, the FDA commissioner on Wednesday.

The FDA  said the number of patients prescribed both classes of drugs increased by 41 percent between 2002 and 2014. To put that into perspective, that means about 2.5 million people and in that same time period fatalities from these two taken together have tripled.

Doctors approve of the FDAs decision

Earlier this year, The Centers for Disease Control and Prevention warned doctors that outside of the treatment of cancer there is little reason to prescribe these two classes of medication together and the risks outweigh the rewards. But for many patients, one doctor is prescribing Oxycontin while another is prescribing Xanax and if not told this by the patient the results are often fatal. That said, the CDC is not in a position to mandate the warnings that the FDA put forward yesterday.

“As an emergency physician, I have seen so many patients who are prescribed opioids and benzodiazepines together,” wrote Dr. Leana Wen, Baltimore’s health commissioner and staunch leader for this FDA warning.  “A black box warning is a powerful education tool and thank [you to the FDA] for taking action to help prevent deaths from this dangerous combination.”

In a call with reporters announcing the new regulations, FDA Commissioner Robert Califf implored (begged) doctors “to heed these new warnings.”

According to Dr. Wen, one in three unintentional overdose deaths that involve prescription opioids also involve benzodiazepines. While yesterday was an important move by the FDA it’s time for law enforcement to get involved as well and begin prosecuting doctors that are clearly over-prescribing opioids before the already ridiculous levels increase and cause more death and destruction.