FDA requires ‘black box’ warning on painkillers

In an attempt to help slow the prescription drug abuse epidemic, the U.S. Food and Drug Administration announced Tuesday that immediate-release opioid painkillers such as oxycodone and fentanyl will now have to carry a “black box” warning about the risk of abuse, addiction, overdose and death.

Prescription opioid painkillers are divided into two main classes – extended release, which have more pain-killing opioid per dosage, and immediate release, which have less opioids, but need to be taken more frequently. Ninety percent of opioid prescriptions are for immediate-release painkillers, the FDA said.

The “black box” warnings are the FDA’s strongest, and they’re meant to educate doctors as they’re prescribing medications to patients.

Here’s how the warning will play out for consumers, according to the FDA.

When a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug. The consumer would need to go to the manufacturer’s website for details.

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In addition, pharmacists are encouraged to provide patients with a medication guide – consumer-friendly language explaining the risks of the drug. Under this new effort from the FDA, all instant-release drugs will need to have such a guide. It is up to the pharmacist to dispense this information, something the FDA encourages.

FDA issued similar warnings in 2013

In 2013, the FDA placed similar warnings on extended-release prescription painkillers. At the time, public health officials and legislators argued that all prescription painkillers should carry the warning. However, FDA officials felt the long-acting, extended-release formulations were leading to more prescription drug abuse.

“The higher dose strength of the extended release was more attractive for abusers,” FDA Commissioner Dr. Robert Califf said. But after that initial action, “we followed the data on misuse … (and) we continue to see misuse and death.”

According to the Centers for Disease Control and Prevention, overdose deaths involving prescription drugs have quadrupled since 1999, and the surge has followed an increase in prescribing. Today, drug overdoses kill more people than car accidents annually with opioids contributing to over 60% of them. More than 40 people a day die from opioid overdoses.

‘Too little, too late’

Sen. Ed Markey, a Democrat of Massachusetts, called the FDA’s actions “too little, too late.”

“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 in a statement.

Dr. Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing, said it was a step in the right direction, but that he was disappointed that maximum dosage and duration limits were not included in the warnings.

But Califf said to consider the needs of patients – for example, a veteran who has another 50 years to live, but has chronic pain.

“Would you put a limit on (his dosing)?” he said.

In a separate press conference, the White House’s Office of National Drug Control Policy announced that letters were sent to every governor to highlight the actions states can take to address the opioid epidemic.

Last month, President Barack Obama proposed an additional $1.1 billion dollars to expand treatment for prescription drug and heroin abuse. Obama will be attending the National Prescription Drug Abuse & Heroin Summit next week in Atlanta, NDCP Director Michael Botticelli announced.

CDC’s opioid dosing guidelines

Califf pointed to opioid dosing guidelines released by the CDC earlier this month.

The CDC’s guidelines state that non-opioid therapy is preferred in most situations. When opioids are used, the lowest possible effective dosage should be prescribed, it said.

There is concern among some patient advocates that this will make chronic pain management more difficult.

But, Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, said, “(T)here is a false dilemma that is posed between reducing opioid use and improving quality of pain care. … I think for far too long, we’ve underestimated the risks.”

Guidelines for hard-to-abuse opioids

In an additional attempt to help slow the abuse epidemic, the FDA announced on Thursday draft guidelines for new abuse-deterrent formulations of generic opioids.

Currently, there are five brand-name, abuse-deterrent formulations on the market: OxyContin, Embeda, Hysingla, Zohydro and Targiniq. For example, the OxyContin version is difficult to crush, making it harder to snort or dissolve.

There are no generic abuse-deterrent formulations. But generics represent more than 90% of the market for opioids, FDA officials said.

Califf said he hoped that all opioids would eventually be abuse-deterrent versions, but he cautioned that there’s still research needed about how effective they are in the real world.

Editor’s Note: An earlier version of this article mistakenly stated that overdoses from prescription narcotics kill more people than car accidents annually. It should have stated drug overdoses overall kill more people than car accidents.