fda opioid warning

Federal regulators issued a new “boxed” warning today on the practice of taking certain opioid and antidepressant medications together.

The high level warning includes the drugs oxycodone, hydrocodone, morphine, and antidepressant drugs known as benzodiazepines.

Officials at the Food and Drug Administration (FDA) said they have become increasingly concerned about the increase in people who take the two types of medications together.

fda black box warning

They noted an FDA review indicated the number of patients being prescribed both an opioid analgesic and a benzodiazepine increased by 41 percent between 2002 and 2014. That translates into 2.5 million more opioid analgesic patients receiving an antidepressant drug.

They added the rate of emergency department visits involving non-medical use of both drug classes increased significantly from 2004 to 2011. Overdose deaths from taking prescribed or greater than prescribed doses involving both drug classes nearly tripled during that period.

“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 Dr. Robert Califf in a statement. “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.”

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Strongest warning

The boxed warnings are the strongest advisory the FDA can issue.

This warning encompasses nearly 400 products identified as opioid analgesics, opioid-based cough products and benzodiazepines used to treat depression.

FDA officials said both types of drugs depress the central nervous system. If taken in too large of doses or in combination, the medications can cause “extreme sleepiness, respiratory depression, coma, and death.”

The new warning requires changes in drug labeling to better inform patients and physicians on the risks associated with taking combinations of the drugs.

It also includes a “drug safety communication” for people who take the drugs and people who know someone who is taking either type of medication.

The warnings are part of the FDA’s Opioids Action Plan, which was unveiled earlier this year in response to the “growing epidemic of opioid abuse, dependence and overdose in the United States.”

It’s also in concert with the guidelines posted in March by the Centers for Disease Control and Prevention (CDC) concerning opioids prescribed for chronic pain.

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Campaign against opioid epidemic

The CDC estimates that nearly 15,000 people in the United States die every year of overdoses involving prescription painkillers.

In addition, they report that nearly one in 20 Americans over the age of 11 reported using prescription painkillers for non-medical reasons during the past year.

This epidemic has resulted in a chorus of increasing concerns from government and health officials this year.

In addition to the CDC and FDA’s guidelines, law enforcements officials said in February that prescription drugs were leading to heroin addictions.

There has also been a crackdown on so-called “pill mill” doctors who are overly lenient in prescribing opioid-based medications.

In June, a survey from Johns Hopkins Bloomberg School Public Health revealed that 60 percent of people who were prescribed opioid painkillers had leftover pills after finishing their treatment.

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