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U.S. NEWSWednesday 23 March 2016

FDA adds boldest warning to most widely-used painkillers

MATTHEW PERRONE drugs that have claimed specify that the drugs like
AP Health Writer the lives of thousands this Percocet should only be
WASHINGTON (AP) — Fed- year alone,” said Sen. Ed- used when other medica-
eral health regulators will ward Markey, D-Mass. tions and alternative ther-
add their strongest warning Opioids are a class of pow- apies cannot control pa-
labels to the most widely- erful and highly-addictive tients’ pain.
prescribed painkillers, part drugs that include both
of a multi-pronged govern- prescription drugs like co- “This new indication, once
ment campaign to stem deine and hydrocodone,
an epidemic of abuse and as well as illegal narcotics, finalized, will remind pre-
death tied to drugs like Vi- like heroin.
codin and Percocet. Deaths linked to misuse scribers that immediate-
The Food and Drug Admin- and abuse of prescription
istration announced Tues- opioids climbed to 19,000 in release opioids are also
day plans to add a boxed 2014, the highest figure on
warning — the most serious record, according to the powerful drugs with impor-
type — to all immediate-re- Centers for Disease Control
lease opioid painkillers, in- and Prevention. Heroin and tant safety concerns,” said
cluding some 175 branded opioid painkillers combined
and generic drugs. caused 28,650 fatal over- Dr. Doug Throckmorton,
Those medications, which doses.
often combine oxycodone Doctors are not required to a deputy director in the
with lower-grade medica- follow the FDA’s instructions
tions, are among the most on drug labels, though they FDA’s drug center.
commonly used drugs in are often used as prescrib-
the U.S. and account for 90 ing guidelines by hospitals, Throckmorton said the
percent of all opioid pain- medical groups and insur-
killers prescribed. ers. agency’s 2013 labeling
The long-awaited change Critics of the FDA, including
comes roughly three years Physicians for Responsible change focused on long-
after the FDA added simi- Opioid Prescribing, called
lar warnings to long-acting on the agency to add such acting drugs like OxyContin
opioid drugs like OxyCon- warnings years ago.
tin, which slowly release “The main driver of our opi- because they represented
their doses over 12 hours or oid epidemic is addiction,
more. The labeling switch and the immediate-release a “disproportionate risk” to
means both immediate products are just as ad-
and extended-release for- dictive,” said the group’s patients, since they contain
mulations will now high- founder, Dr. Andrew Kolod-
light the risks of addic- ny, an addiction therapist larger opioid levels.
tion, abuse, overdose and with Phoenix House, a net-
death. work of rehabilitation clin- Government officials
“We’re at a time when the ics.
unfathomable tragedies The new FDA label will have tried a variety of ap-

proaches to tackling pain-

killer abuse in recent years.

In this Aug. 5, 2010, file photo, a pharmacy technician poses for The FDA previously restrict-
a picture with hydrocodone and acetaminophen tablets, also
known as Vicodin, at the Oklahoma Hospital Discount Pharma- ed combination pills like Vi-
cy in Edmond, Okla.
codin to limit refills and who
Associated Press
can prescribe them. States

like Florida and New York

resulting from addiction, mation.” have cracked down on
overdose and death have But lawmakers from states
become one of the most that have been ravaged “pill mills” using databases
urgent and devastating by opioid addiction said
public health crises facing such labeling changes to monitor what doctors
our country,” FDA Commis- have “done little” to help
sioner Dr. Robert Califf said their communities. are prescribing.
on a call with reporters. “I
can’t stress enough how “Unfortunately, it has taken In a separate briefing Tues-
critical it is for prescribers to FDA far too long to address
have the most current infor- the grave risks of these day, the Obama adminis-

tration’s drug czar praised

the move by the FDA and

Califf, who was confirmed

to lead the agency last

month.q