FDA calls for boxed warnings – its strongest warning – about dangers of drug-combining opioids with benzodiazepines

FDA calls for boxed warnings – its strongest warning – about dangers of drug-combining opioids with benzodiazepines

We’ve advised readers many times about the dangers of drug-combining – taking two or more drugs that, in combination, create life-threatening side effects.

The most common dangerous combination is opioids and benzodiazepines. Both classes of drugs depress the central nervous system (CNS), which controls breathing and heartbeat. And together, they can quietly snuff out a life before anyone notices anything wrong, including the victim. The effect is exactly the same as a heroin overdose – the breathing stops, the person dies. But there was no overdose of either drug – the combination creates the overdose that kills.

To combat this long-standing and widely publicized danger, the FDA has finally decided to push the message to health care providers and especially to patients, to avoid mixing these two drug types. The agency is calling for “boxed warnings” – its strongest form of warning – to be added to the labels of no less than 389 individual opioid and benzodiazepine products. The types of medicines to get the new labels include all benzodiazepines, prescription opioid painkillers and opioid-containing cough suppressants such as over-the-counter cough and cold products that contain codeine or other opioids.

Info on the new labels will boldly state the serious risks associated with using these medications together, including extreme sleepiness, respiratory depression, coma and death. “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 FDA Commissioner Robert Califf, M.D. “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.”

The agency said the labeling plans are “one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.” The FDA reviewed data that showed physicians have been increasingly prescribing benzodiazepines and opioids together, and the practice is associated with adverse outcomes. The agency concluded that “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.”

Between 2002 and 2014, the number of patients each year who were prescribed opioids rose from 75 million to 81 million, while benzodiazepine prescriptions rose from 23 million to 30 million a year. This added more than 2.5 million patients who were prescribed both an opioid analgesic and a benzodiazepine – a 41 percent increase– the agency added. Douglas Throckmorton, MD, of the FDA’s Center for Drug Evaluation and Research, told PainMedicineNews: “We know that ER visits and deaths in patients given benzodiazepine and opioids has increased significantly." And Baltimore Public Health Commissioner Leana Wen, MD, said: “In recent years, we public health officials have noticed an alarming trend. Nearly one in three unintended overdose deaths from prescription opioids also involved benzodiazepine.”

The key thing here is to be aware of the risk of combining opioids and benzodiazepines – even an over-the-counter cough medicine and a single Valium or Xanax. Know that the risk of overdose is ever-present when combining these two kinds of drugs. And also keep in mind that Novus successfully treats opioid and benzodiazepine dependence. We are here to help people get their lives back from drug dependence and addiction.

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