In announcing the new label requirements for opioid analgesics, FDA Commissioner Margaret A. Hamburg said her agency was taking the step "to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities."
"Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended-release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain," she said in a statement posted to the FDA's website.
She said the labeling changes, which have yet to be finalized, will include new language aimed at helping healthcare professionals tailor their prescribing decisions on a patient's individual needs. The updated labels will state long-acting and extended-release opioid medications are indicated for the management of pain severe enough to require daily, around-the-clock treatment and for which alternative treatment options are inadequate.
The labels will also clarify that, because of the risks they present, the drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.
"These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs," said Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research.
The FDA also will require drug companies that make these products to conduct additional studies and clinical trials to further assess their dangers.
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