Pubdate: Mon, 28 Jan 2013
Source: Wall Street Journal (US)
Copyright: 2013 Dow Jones & Company, Inc.
Authors: Thomas Catan And Timothy W. Martin


WASHINGTON - Federal drug safety advisers recommended new restrictions
on a type of widely used narcotic painkiller, amid concern that the
drug is fueling a surge in addiction and overdose deaths.

After two days of testimony, the Food and Drug Administration's drug
safety advisory panel voted 19-10 to recommend that products
containing hydrocodone - a category that includes Vicodin - should be
reclassified as Schedule II controlled substances, along with other
narcotic painkillers such as oxycodone. Hydrocodone products are
currently in Schedule III.

If approved, the move would change how doctors prescribe pills that
are taken by tens of millions of Americans. They would be able to
prescribe fewer pills at one time. The pills would also be subject to
more stringent handling and storage rules.

The advisory committee's recommendation isn't binding, but advocates
of the move said that the margin of the vote would make it difficult
for the FDA to ignore.

"I believe the schedule change will mark a turning point in the
epidemic," said Andrew Kolodny, a New York psychiatrist who advocates
more selective use of hydrocodone and other drugs known as opioids
because of their resemblance to derivatives of opium.

If implemented, the changes would "help prevent these highly addictive
drugs from getting into the wrong hands," said Sen. Joe Manchin, a
West Virginia Democrat who proposed legislation last summer to tighten
controls on hydrocodone products.

A spokesman for the Generic Pharmaceutical Association, which
represents several opioid manufacturers, said companies would abide by
whatever the FDA decides, but he said that the change in schedule
would not in itself be enough to solve the problem of abuse.

According to the Centers for Disease Control and Prevention, more than
16,500 people died after overdosing on opioid-based painkillers in
2010, the most recent data available. No other class of drugs, legal
or illegal, is responsible for as many deaths, its figures show.

The FDA had rejected several previous requests by the Drug Enforcement
Administration to reclassify hydrocodone products. The FDA and DEA
declined to comment on Friday's vote.

Drug safety groups and family members of overdose victims have long
pushed for the move, arguing that the hydrocodone products were no
less addictive or prone to abuse than more tightly controlled drugs
like OxyContin. However, some pain medicine groups warned that the
move could make it harder for legitimate patients to get their
medications, and make doctors more reluctant to prescribe them.

"I hope people in pain won't suffer as a result," said Lynn Webster,
president-elect of the American Academy of Pain Medicine.

The generic version of Vicodin, a blend of hydrocodone and the
non-narcotic painkiller acetaminophen, is the most widely prescribed
medication in the U.S., according to IMS Health Inc., which tracks
pharmacy drug sales. Hydrocodone drugs are commonly prescribed to
treat acute pain in patients such as those who have broken bones or
undergone dental surgery.

Some 47 million patients were given prescriptions for hydrocodone in
2011, according to the FDA. Americans use 99% of the world's
hydrocodone supply, according to a 2005 study by the International
Narcotics Control Board, which implements United Nations drug

"Is hydrocodone the most abused pharmaceutical in the U.S.?
Absolutely," said John Burke, president of the National Association of
Drug Diversion Investigators, a nonprofit group that works with law
enforcement, doctors, state and manufacturers to curb prescription
drug abuse.

In December, an FDA advisory panel also voted against approving the
first pure hydrocodone product amid fears that it could become a
widely abused drug.

The FDA must also soon decide whether to intervene to stop cheap,
generic copies of two widely abused drugs - OxyContin and Opana -
from being marketed in the U.S. this year.

The generic copies currently lack the crush-resistant formulations of
the brand name drugs, potentially making them attractive to those who
wish to abuse them. 
- ---
MAP posted-by: Jo-D