Doctors petition FDA for 'black box' warning on combining painkillers, tranquilizers

Public health directors from around the nation demanded the FDA label prescription painkillers and sedatives with its strongest warning in a petition delivered to the federal agency Monday.

Thirty city and state health directors from across the USA are seeking a "black box" warning on the drugs, which can cause fatal overdoses when combined.  The demand comes states and cities wrestle with growing painkiller abuse, which the Centers for Disease Control has called an epidemic.

Local and state health directors "are on the front lines of the opioid epidemic," said Leana Wen, the Baltimore health commissioner. "All of us have seen the toll of overdose deaths."

The combination of opioid painkillers, such as OxyContin and Vicodin, and sedatives called benzodiazepines, which include Valium and Xanax, can make people stop breathing, said Nicole Alexander-Scott, director of the Rhode Island Department of Health.

Adding a  prominent warning to drug labels would alert both physicians and patients to the risks, said Alexander-Scott, who submitted a petition to the FDA Monday. A dozen additional doctors and health leaders cosigned the petition.

"These kinds of warnings work," Alexander-Scott said. "Our voices are amplified if we all speak to the FDA in unison."

Nearly 44,000 Americans died from drug overdoses in 2014, including 23,000 who overdosed on prescription drugs. About 70% of prescription drug overdoses were due to opioid painkillers, with 30% due to benzodiazepines, according to the CDC.

The number of people hospitalized for addiction treatment for opioids and benzodiazepines rose from 5,032 in 2000 to 33,701 in 2010, according to the Substance Abuse and Mental Health Services Administration.

"The numbers are absolutely staggering," Alexander-Scott said.

Wen said she's had encouraging talks with the FDA and hopes the agency will agree to add the warnings.

"The FDA appreciates the diligent work of the state and city public health leaders in raising concerns," said FDA spokeswoman Sarah Peddicord.  "The FDA is committed to working with the health care community and our federal, state, and local partners to help reduce opioid and benzodiazepine misuse and abuse. We will continue to monitor the combined use of these products and take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications."

Sen. Edward Markey, D-Mass., who is sharply critical of the Food and Drug Administration's regulation of painkillers, last month placed a hold on the Senate's consideration of President Obama's nominee for FDA commissioner, Robert Califf,  currently the agency's deputy commissioner for medical products and tobacco. Markey has vowed to vote against Califf's nomination in protest of FDA actions.

"The FDA is part of the opioid problem and America is depending on it to be part of the solution," Markey said at a Washington press conference Monday. "We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers."

The FDA committed publicly to increasing the number of painkillers available in "abuse-deterrent" forms that are difficult to crush, snort or inject. But in 2013, the agency drew fire when it approved an extended-release painkiller called Zohydro in a form that's easily crushed, overruling the vote of an expert advisory committee that recommended rejecting the drug.

Since then, the FDA has approved three new painkillers without consulting advisory committees at all. Approving drugs without public hearings and consultation from outside specialists allows the FDA to make critical decisions in the dark, said Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing.

The FDA has responded to these criticisms by releasing a "comprehensive action plan" to reduce opioid abuse. The agency says it will re-examine the risks and benefits of new painkillers and convene advisory committees before approving opioids that aren't designed to deter abuse. The agency said it also will change the way it labels immediate-release painkillers to provide more safety information. And the FDA will require that drug companies perform additional studies on the effects of long-term painkiller use.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” Califf said when announcing the FDA plan earlier this month. “This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis.”

Markey said Monday that the FDA's response doesn't go far enough. He said the FDA should consult independent experts when evaluating all future opioid painkillers, not just those that are easy to abuse. The FDA also should factor in the potential for addiction and abuse when determining whether new painkillers are safe, he said.