Report: FDA issues ‘Black Box’ warning on combined use of Opioids and Anxiety Medication

A press release this week from the The Food and Drug Administration is warning that patients and doctors should be aware of the life-threatening risks of combining anti-anxiety or sleep medications with prescription opioids.

The FDA is requiring that specific products carry a ‘black box warning’ that highlights the risks from combined use.

Among the changes, the FDA is also requiring patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines (nearly 400 products in total) with information about the serious risks associated with using these medications at the same time. Risks include extreme sleepiness, respiratory depression, coma and death.

In February 2016,  health officials in cities and states across the country petitioned the agency for the change to the drug labels, citing an increase in overdoses from simultaneous use of the drugs.

According to the FDA, from 2004 to 2011 the rate of emergency department visits involving non-medical use of both drug classes increased significantly. Overdose deaths from taking prescribed or greater-than-prescribed doses of both drug classes nearly tripled.

The number of patients who were prescribed both an opioid painkiller and a benzodiazepine increased by 41 percent during the period studied, translating to an increase of more than 2.5 million opioid patients receiving benzodiazepines.

“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.

Painkillers and cough treatments containing opioids that will be required to carry the new warning include oxycodone, hydrocodone and morphine, among other drugs.

The benzodiazepines that will get the warning are sold under a variety of brand and generic names, including Xanax, Valium and lorazepam. They often called tranquilizers or sleeping pills for their ability to relieve anxiety, insomnia and seizures.

While Opioids have legitimate medical uses in treating pain and cough, they can also cause drowsiness, dizziness, nausea, vomiting, constipation and slowed or difficulty in breathing. Benzodiazepines also cause some of these same side effects, which is a principal reason why using the two drugs together can potentially be deadly.

There are some medical conditions for which the combined use of these drugs is desirable and effective, including some treatments for opioid addiction and dependence. The FDA says it is continuing to examine available evidence regarding these uses.