FDA Adds 'Black Box' Warning to Painkillers

by | March 23, 2016

By Tony Pugh

The nation's prescription opioid and heroin abuse epidemic took center stage in Washington on Tuesday as the White House, Congress and regulatory agencies all weighed in on the issue that has captured the attention of Democrats and Republicans.

The Food and Drug Administration announced Tuesday that fast-acting opioid pain relievers will begin carrying "black box" warnings about the risk of abuse, addiction and overdose deaths that the popular medications pose.

Opioids are a class of narcotic pain medications that include prescription drugs such as OxyContin, Percocet and morphine, along with the illegal drug heroin.

The epidemic has helped fuel a similar increase in heroin usage and overdoses, since prescription opioids are often a gateway to heroin abuse.

Manatee County, south of Tampa, is the center of Florida's heroin abuse problem, with more heroin overdose deaths per capita in 2014 than any other Florida county. Manatee and Sarasota county areas saw heroin overdose deaths double to more than 150 in 2015, compared with 63 in 2014 and just 19 in 2013.

On Monday, Republican U.S. Rep. Vern Buchanan of Bradenton visited St. Joseph's Hospital-South to discuss how he thinks the medical community and federal government can better help to prevent drug abuse.

The new FDA guidelines announced Tuesday call for the prescription labels to warn that opioids can cause a dangerous central nervous system reaction if they interact with antidepressants and migraine medications.

Labels will also warn that opioid use can cause a rare condition in which the adrenal glands don't produce enough cortisol, a hormone that helps the body handle stress. New labels will also explain that long-term opioid use is associated with lower sex hormone levels and reduced interest in sex, as well as impotence and infertility.

On Tuesday afternoon, the White House announced that President Barack Obama will speak at the National Prescription Drug Abuse & Heroin Summit on March 29 in Atlanta.

Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, said the president's participation is symbolic and substantive.

"The president's presence at this summit really indicates how widely this issue is resonating, how important it is to the administration and what a priority it is to us to do everything we can to help turn the tide on this terrible epidemic," Frieden said in an afternoon conference call with reporters.

Obama's 2017 budget proposal calls for $1.1 billion in new federal money to combat the growing abuse of heroin and prescription painkillers in the U.S.

During a Tuesday hearing of the House Committee on Oversight and Government Reform, lawmakers heard that local and state governments are struggling with a dramatic increase in the price of naloxone, an emergency-use drug that blocks and reverses the effects of prescription opioid and heroin overdoses.

Michael Botticelli, director of National Drug Control Policy at the White House, said during the conference call he was "tremendously disturbed' by the price hikes.

Botticelli said the FDA is trying to address the problem by quickly approving more naloxone products _ like a nasal spray version _ in order to increase competition and lower prices.

In addition, Frieden said the CDC is working with organizations representing counties, mayors, cities and governors to pool their purchasing power to lower the cost of naloxone.

The Department of Health and Human Services also has asked state Medicaid directors to include naloxone on their list of covered medications, Frieden said, so that more friends and families of abusers have access to the lifesaving drug.

The flurry of activity comes after the CDC issued new guidelines last week that call for doctors to try less addictive painkillers, like aspirin and ibuprofen, before prescribing opioids to patients.

The guidelines, which are not mandatory, recommend that opioids be prescribed mainly for short-term pain episodes of three to seven days.

Also on Tuesday, the White House sent letters to all the nation's governors highlighting the best practices that states have taken to combat substance abuse.

They include legislation by 14 states requiring all prescribers to receive opioid training, and legislation by 22 states requiring pharmacists to submit drug-dispensing data to state prescription drug monitoring programs within 24 hours.

(c)2016 McClatchy Washington Bureau