The U.S. Food and Drug Administration announced new additions to the warning labels of immediate-release opioid painkillers on March 22.
The warnings are part of the agency’s response to the rampant abuse of opioids such as oxycodone and hydrocodone in recent years. More people died from overdoses after taking opioids in 2014 than in any previous year.
The labels of the opioids will now include black-box warnings — the FDA’s strongest warning — about the risks of misuse, abuse, addiction, overdose and death.
“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 Califf said in a 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,” Califf said.
The FDA’s goal is to reduce drug overdoses and harmful side effects caused by opioids without denying patients sufficient access to pain relief.
The agency is adding other warnings to the labels, too, including:
- When taken with antidepressants or medications that treat migraines, opioids can cause serotonin syndrome — a potentially fatal condition that can cause fever and seizures.
- Opioids can cause a rare condition that interrupts the body’s ability to produce cortisol, a hormone used to regulate stress.
- Long-term opioid use may lead to a reduction in sex hormones and cause low libido or infertility.
The agency also issued safety communication recommending doctors prescribe opioid treatment only when other treatment options are not possible. The organization also clarified dosing, monitoring and discontinuation instructions.
The FDA added a black-box warning about the risk of neonatal opioid withdrawal syndrome when opioids are used during pregnancy. NOWS can be life-threatening if the infant does not receive treatment.
“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with immediate-release opioid products,” said Dr. Douglas Throckmorton, deputy center director of regulatory programs at the FDA’s Center for Drug Evaluation and Research. “We have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications.”
FDA Continuing to Expand Opioid Warnings, Guidance
The new warnings are the latest in a series of steps taken by the FDA in recent years to reduce the negative side effects of the prescription drugs.
In April 2015, the FDA issued its final guidance to the pharmaceutical industry recommending the development of brand name abuse-deterrent pills.
“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” former FDA Commissioner Margaret Hamburg said in 2015. “We feel this is a key part of combating opioid abuse.”
Abuse deterrent pills are difficult to crush and turn into a thick gel when melted. The pills make it extremely difficult for drug users to snort or inject the drugs. Snorting or injecting opioids drastically increases a person’s risk for harmful side effects such as seizure, coma and death.
The FDA approved an abuse-deterrent version of extended-release OxyContin, one of the most widely abused opioids, in 2010.
The agency updated labels of extended-release opioids three years later, recommending the drugs only be prescribed for severe pain which requires long-term, around-the-clock treatment. The new labels also warned about the risks for addiction, abuse and misuse of extended-release opioids.
FDA Issues Guidance for Generic Abuse-Deterrent Opioids
On March 24, the FDA announced new information on how it will evaluate and approve generic versions of abuse-deterrent opioids. The agency had previously announced information regarding only brand name drugs.
“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” Califf said. “We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”
The FDA is asking drug manufacturers to conduct long-term studies to assess the safety of the generic drugs, and the agency is accepting feedback from industry experts.