Drug Alert: FDA Now Requires Strongest Possible Warnings for Potentially Deadly Immediate-Release Opioid Painkillers

Prescription opioid painkiller abuse has skyrocketed here in Georgia and across the country. According to the Centers for Disease Control and Prevention, overdose deaths involving prescription drugs have quadrupled since 1999, prescription drugs actually kill more people than car accidents every year, and more than 40 people a day die from opioid overdoses. These horrific statistics have prompted the U.S. Food and Drug Administration (FDA) to now require the strongest possible warnings – the “black box” warning – on all immediate-release opioid painkillers.

In its March 2016 announcement of the new labeling requirements, the FDA noted that “Opioid addiction and overdose have reached epidemic levels over the past decade,” and that the updated warnings were part of the FDA’s “commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids.”

There are two main types of prescription opioid painkillers – extended-release and immediate-release. According to the FDA, immediate-release (IR) painkillers make up approximately 90% of opioid prescriptions in the U.S.

As set forth in the FDA’s announcement:

IR opioid pain medications now require a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.
The new IR opioid warnings will include a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated.
The FDA is requiring updated labeling for all opioids (both extended release and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome.
Updated labeling will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency).
The FDA is also aware of, and carefully reviewing, available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids.
The FDA is encouraging pharmacists to give all patients receiving opioid pain drugs a medication guide containing consumer-friendly language explaining the risks of the drug.

All efforts to prevent senseless and preventable deaths and injuries from painkiller misuse and abuse should be supported, and the FDA’s announcement is a welcome part of that efforts.

At The Parian Law Firm in metro Atlanta, Georgia, we represent injury victims exclusively and are committed to getting justice and compensation for our clients. Please contact us at (770) 727-5550 or chat live online with a member of our staff today.