- The Food and Drug Administration on Tuesday mandated all immediate-release opioid painkillers carry its strongest warning, as part of its new efforts to overhaul its approach to opiods. After months of intense criticism from lawmakers over the growing rates of opioid overdose death and abuse, the FDA in February began to unveil changes to how the agency treats the powerful drugs.
- Immediate-release (IR) opiod analgesics are intended for use every four to six hours, and will now have a boxed warning about the risk of addiction, overdose, and possible death.
- In addition to the changes for IR opiods, the agency also announced class-wide changes for all opioids, requiring labels to include information on the drugs' effects on the endocrine system, and on sex hormone levels.
The FDA's heightened warning requirements build upon initial efforts made by the agency in February to strengthen its scrutiny over the drugs. Due to those earlier changes, the agency now requires advisory committees to be convened before any opioid painkiller which doesn't have abuse-deterrent properties.
With Tuesday's changes, all IR opioids will carry an updated indication stating the drugs should be reserved only for pain severe enough to require opioid treatment and for which no other alternatives are appropriate.
"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," said FDA Commissioner Robert Califf.
Lawmaker anger over the opiod approval process played a role in delaying his confirmation as commissioner so it is little surprise this issue has been on Califf's agenda out of the gate.
Senator Ed Markey (D-MA), who has been vocal on this issue and opposed Califf's confirmation, released a statement after the announcement questioning whether the labels will make a significant impact on the growing levels of abuse.
"Whether it's immediate or extended release, or abuse-deterrent, the labels given by the FDA have done little to prevent opioid addiction. Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone," Markey said.
Recently, the Centers for Disease Control and Prevention has also moved to address the epidemic, issuing voluntary recommendations to physicians for prescribing opioid painkillers. The guidelines recommended physicians turn first to NSAIDS such as ibuprofen when a patient presents with pain, as well as instructing doctors to prescribe lower doses for shorter periods of time.