The Food and
Drug Administration is recommending new restrictions on prescription medicines
containing hydrocodone, the highly addictive painkiller that has grown into the
most widely prescribed drug in the U.S.
In a major
policy shift, the agency said in an online notice Thursday that
hydrocodone-containing drugs should be subject to the same restrictions as
other narcotic drugs like oxycodone and morphine.
The move
comes more than a decade after the Drug Enforcement Administration first asked
the FDA to reclassify hydrocodone so that it would be subject to the same
restrictions as other addictive painkilling drugs. The FDA did not issue a
formal announcement about its decision, which has long been sought by many
patient advocates, doctors and state and federal lawmakers.
For decades,
hydrocodone has been easier to prescribe, in part because it is only sold in
combination pills and formulas with other non-addictive ingredients like
aspirin and acetaminophen.
That ease of
access has made it many health care professionals' top choice for treating
chronic pain, everything from back pain to arthritis to toothaches.
In 2011,
U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making
it the most prescribed drug in the country, according to government figures.
The ingredient is found in blockbusters drugs like Vicodin as well as dozens of
other generic formulations.
It also
consistently ranks as the first or second most-abused medicine in the U.S. each
year, according to the DEA, alongside oxycodone. Both belong to a family of
drugs known as opioids, which also includes heroin, codeine and methadone.
Earlier this
year the Centers for Disease Control and Prevention reported that prescription
painkiller overdose deaths among women increased about fivefold between 1999
and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death
rates is closely tied to a boom in the overall use of prescribed painkillers.
The FDA has
long supported the more lax prescribing classification for hydrocodone, which
is also backed by professional societies like the American Medical Association.
But the
agency's top drug regulator, Dr. Janet Woodcock, said in a statement Thursday:
"The FDA has become increasingly concerned about the abuse and misuse of
opioid products, which have sadly reached epidemic proportions in certain parts
of the United States."
The FDA says
it will formally request in early December that hydrocodone be rescheduled as a
Schedule II drug, limiting which kinds of medical professionals can write a
prescription and how many times it can be refilled.
The
Controlled Substances Act, passed in 1970, put hydrocodone drugs in the
Schedule III class, which is subject to fewer controls. Under that
classification, a prescription for Vicodin can be refilled five times before
the patient has to see a physician again. If the drug is reclassified to
Schedule II, patients will only be able to receive one 90-day prescription,
similar to drugs like OxyContin. The drug could also not be prescribed by
nurses and physician assistants.
The FDA's
request for reclassification must be approved by officials in other agencies
within the Department of Health and Human Services.
News of the
FDA decision was applauded by lawmakers from states that have been plagued by
prescription drug abuse, many who have been prodding the agency to take action
for months.
"Today
was a tremendous step forward in fighting the prescription drug abuse epidemic
that has ravaged West Virginia and our country," said Democratic Sen. Joe
Manchin, in a statement. "Rescheduling hydrocodone from a Schedule III to
a Schedule II drug will help prevent these highly addictive drugs from getting
into the wrong hands and devastating families and communities
Sen. Charles
Schumer of New York noted that the FDA's own expert panel recommended the
reclassification more than nine months ago.
"Each
day that passes means rising abuse, and even death, at the hands of
hydrocodone-based drugs," Schumer said in a statement.
Still,
Thursday's action immediately sparked criticism from some professional groups
that said that the tighter restrictions could have unintended consequences,
such as burdening health care workers and patients.
Source : foxnews.com
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