Pubdate: Wed, 23 Mar 2016
Source: Washington Post (DC)
Copyright: 2016 The Washington Post Company
Author: Lenny Bernstein


FDA Commissioner Notes Public Health Crisis From Narcotic Painkillers

The Food and Drug Administration announced Tuesday that it will 
require new warnings about the risk of addiction, abuse, overdose and 
death for shortacting opioid pain medications, one step toward 
curbing the nation's epidemic of narcotic use.

The "black box" cautions for immediate-release medications - powerful 
narcotics intended for use every four to six hours - also will warn 
of the danger that chronic use of the drugs by pregnant women can 
pose. Their newborns face the painful process of withdrawal, known as 
neonatal opioid withdrawal syndrome.

In a media briefing, FDA Commissioner Robert Califf called opioid 
addiction one of the most "urgent and devastating public health 
crises facing our nation" and said the new labels were just part of 
the government's larger strategy for addressing it.

But Sen. Edward J. Markey (D-Mass.), who delayed Califf 's 
confirmation and demanded that the agency overhaul its approval 
process for opioid medications, faulted the move as inadequate. 
"Unfortunately, it has taken the 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.

The FDA, which has been criticized as too willing to approve the 
painkillers and too slow to fight their abuse, last month outlined a 
wide-ranging strategy to overhaul its opioid policies.

Its new warnings will emphasize that immediate-release opioids should 
be a last resort for severe pain when other painkillers don't work or 
can't be tolerated by patients. Dosing information will provide 
clearer instructions to prescribers about how to administer the drugs 
and monitor patients, along with a warning to not "abruptly stop 
treatment in a physically dependent patient," according to an FDA news release.

These messages will apply to more than 200 short-acting opioid 
products, including widely prescribed medications such as oxycodone, 
hydrocodone and others that represent about 90 percent of the 
products on the market. Similar warnings were added to packaging for 
extended release medications in 2013, said Douglas Throckmorton, 
deputy director of regulatory programs for the FDA's Center for Drug 
Evaluation and Research. In May, the FDA will evaluate whether that 
labeling change reduced opioid addiction.

The FDA action came as a congressional oversight committee probes the 
causes and effects of the epidemic and as federal government action 
to counter the impact of opioids has finally begun to gather momentum.

Last week, the Centers for Disease Control and Prevention issued the 
first national guidelines for doctors on the use of opioids. They 
urge physicians to use more caution and to consider alternatives 
before they prescribe highly addictive narcotic painkillers. The 
Senate recently passed legislation that would expand drug abuse 
treatment and prevention.

Deaths from opioid overdoses - both prescription narcotics and 
illicit street drugs such as heroin - reached a record 28,647 people 
in 2014, according to the CDC. Overdoses from all forms of drugs now 
kill more Americans than vehicle crashes or shootings.

One recent study showed that 14 percent of pregnant women have been 
prescribed the powerful opioid medications for pain. Another revealed 
a quadrupling in the number of drug-exposed children in neonatal 
intensive care units.

FDA officials said the new warnings will be finalized by the end of 
2016 and will affect 87 brand-name drugs and 141 generics. Soon 
after, drug manufacturers will be required to include the highlighted 
warnings on packaging and in updated guides for using the 
medications. Current packages that lack the warnings will not be recalled.

The new labeling also will include warnings about interactions with 
other medicines that can cause a serious central nervous system 
condition called serotonin syndrome, the chance of a rare disorder 
called adrenal insufficiency and the possibility of decreased levels 
of sex hormones.
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MAP posted-by: Jay Bergstrom