Opioid Painkillers Get Boxed Warning On Abuse, Antidepressant Interactions, Adrenal Side Effects

Federal regulators will require opioid painkillers like OxyContin and hydrocodone to carry a new black box warnings about the risk of misuse, abuse, addiction, overdose and death. In addition, the drugs will require new safety warnings about maternal use, interactions with antidepressants and migraine medications, adrenal insufficiency and decreased sex hormone levels. 

The FDA announced the new opioid warnings on March 22, which the agency says is one of a number of steps being taken to make the powerful drugs safer for consumers.

The agency is also stressing that immediate-release opioids should be reserved for severe pain that cannot be alleviated by alternative treatment options.

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“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” FDA Commissioner Robert Cardiff said in the press release. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

The black box warning, the strongest label warning the FDA can require, will warn of the risk of misuse, abuse and overdose. It will also warn that the chronic use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can threaten the life of a newborn if not quickly recognized by healthcare providers.

In addition, the FDA also issued a drug safety communication announcing that the painkillers will also include new label warnings on serotonin syndrome, which occurs when high levels of serotonin build up in the brain and turn toxic. This can occur when opioids are taken in conjunction with antidepressants and migraine drugs, which also increase serotonin levels.

The drugs will also carry warnings of a rare but serious condition known as adrenal insufficiency, which has been linked to fentanyl, oxycodone, buprenorphrine, hydromorphone and tramadol. This causes the adrenal glands to fail to produce enough of a hormone called cortisol, which helps the body respond to stress.

Another warning the drugs will carry will be a warning of the risk of decreased sex hormone levels, which could result in less interest in sex, impotence and infertility.

Opioid Painkiller Abuse

The new label warnings follow a recent announcement of new opioid use guidelines by the U.S. Centers for Disease Control and Prevention (CDC).

The CDC urges doctors to make sure patients are educated on the risks of opioid pain killers. The CDC guidelines focus on 12 principles, calling on doctors to encourage patients to use other effective treatments available, including non-opioid medications, ice, talk therapy, and exercise therapy, which has been shown to help reduce chronic low back, knee, and hip pain.

The guidelines also call on doctors to let patients know what they can expect, that they will not be 100% pain free, to communicate and set realistic pain treatment goals, and to never start with the long-acting opiates, instead using the lowest possible dose.

The CDC reported in December that drug overdose deaths have reached an all-time high in the U.S., increasing 137% since 2000. Overdoses involving prescription opioid painkillers, such as Vicodin and OxyContin, have reached record levels. In 2014, more than 60% of overdose deaths involved some type of narcotic painkiller.


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