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New FDA Rule Requires Warning Labels On Opioid Drugs Make Addiction, Overdose Risks More Apparent

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The FDA now requires a new boxed warning on opioid drugs to indicate risk of misuse, abuse, addiction, overdose, and death. Reuters

Abuse of opioid drugs meant to relieve pain has reached epidemic proportions in the United States. Since 1999, the number of patients complaining of pain has remained consistent, yet sales of prescription pain pills — and deaths caused by opioid overdoses — have nearly quadrupled. The Food and Drug Administration (FDA) is now requiring a new boxed warning on opioid pain medications to indicate the serious risks of misuse, abuse, addiction, overdose, and death.

While only immediate-release opioid pain medications require the new box warning, the agency is also demanding new safety alerts on the labels of all opioid medications.

Commonly, pharmacists divide prescription opioids, including oxycodone, hydrocodone, and morphine, into two main categories: Immediate release products are intended for use every four to six hours, while extended-release (long-acting) formulas should be taken once or twice a day.

Immediate release opioids, according to the FDA’s new label specifications, should now be reserved for severe pain unable to be treated by alternative products, such as non-opioid pain killers or opioid combination products.

For all opioid medication labels, the agency is requiring safety information about harmful drug interactions with other medicines. At the same time, the FDA spells out additional instructions to doctors about how opioids should be administered to patients. Initial dosage, dosage changes during therapy, and a warning not to abruptly stop treatment in a physically dependent patient will be added to all the new labels.

On the boxed warning drugs only, the FDA is demanding an additional precaution that chronic use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome. If not recognized and treated properly, this syndrome may cause the death of a newborn baby.

Despite the new label requirements, the fact that many Americans suffer from pain, in some cases chronic pain, is widely acknowledged by public health officials.

“It is vital that we identify effective non-pharmacological treatment options for 25 million people who suffer from daily pain in the United States,” said Dr. Josephine Briggs, director of National Center for Complementary and Integrative Health (NCCIH), in a related statement to the press. Aligned with the FDA announcement, Briggs provided news of a study focused on treatments for low back pain.

The new research indicates mindfulness-based stress reduction and cognitive behavioral therapy (CBT) are more effective than drugs in alleviating chronic low-back pain. Mindfulness based therapy brings together elements of meditation and yoga, while CBT trains people to change specific thoughts and behaviors.

For the NCCIH-funded study, researchers divided 342 patients into three groups. One group received usual care, which included prescription drugs (either opioids or non-opioids) and a doctor’s supervision, for one year. A second group attended mindfulness therapy sessions for eight weeks. And a the third group attended CBT sessions for eight weeks.

At 26 and 52 weeks, participants practicing mindfulness therapy and CBT showed greater improvements in their back pain and back function compared to the group receiving medication. At 52 weeks, only those using mindfulness therapy continued to see improvements.

Based on these results, the researchers concluded mindfulness-based stress reduction therapy may be an effective treatment for many patients with chronic low-back pain. Apparently, opioids and other drugs are not superior to the human mind in all circumstances, including times when the body is experiencing extreme pain.

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