BETHESDA, MD 22 Mar 2016—The labeling for all immediate-release opioid products must have a boxed warning and state that they "should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options . . . are inadequate or not tolerated," FDA announced today.
"When this action is finalized," said Doug Throckmorton, deputy director for FDA's drug regulatory programs, "we're going to need to change the labels of 87 innovator products and 141 generics. It's a much larger action than we took in 2013."
That action in 2013 affected the labeling for about 8 extended-release and long-acting opioid products, Throckmorton said during a briefing for reporters.
One of the results of that 2013 action is the boxed warning that now appears in the labeling of all extended-release and long-acting opioid products.
The intention of the "new indication" for immediate-release opioid products, Throckmorton said, is to "remind" prescribers that those products contain powerful drugs with important safety concerns and "need to be used with great care after careful discussion between patients and their doctors."
He said the agency is also requiring the addition of a medication guide to help patients avoid serious adverse effects from using immediate-release opioid products.
FDA, in announcing the labeling changes, said the boxed warning will emphasize to clinicians "the serious risks of misuse, abuse, addiction, overdose and death" for patients using an immediate-release opioid product.
The boxed warning will also state that chronic use of opioids by pregnant patients can result in their babies having neonatal opioid withdrawal syndrome, FDA said.
Sharon Hertz, director of the FDA division that reviews analgesia drug products, said the agency informed the drug companies by letter today.
Review of the material that will be submitted by the companies is expected to be completed by the end of 2016, she said.
The upcoming boxed warning, stated Deborah Pasko, with the ASHP Center on Medication Safety and Quality, should not stop healthcare providers from prescribing the immediate-release products if opioid therapy is truly needed, even in pregnant patients.
"I would encourage pharmacists to continue medication counseling based upon patient-specific needs and medication therapies" regardless of the drug or whether a product's labeling bears a boxed warning, she said.
But with the "heightened awareness" to opioids, Pasko added, pharmacists should "pay special attention" to any type of opioid therapy.
Along with announcing that the labeling for all immediate-release opioid products will have a boxed warning, new indication, and medication guide, FDA said the labeling for all opioids products will have information about the following risks:
- Serotonin syndrome, from the interaction of opioids with antidepressants and migraine medications,
- Adrenal insufficiency, from opioids' interference with cortisol production, and
- Decreased sex hormone levels, from the long-term use of opioids.
The information will appear in sections of the labeling other than the boxed warning, FDA said.