NEW WARNING ISSUED ON METHADONE

This is part of an ongoing Gazette investigation of methadone, a drug
that has the unique ability to kill if you don't take it exactly as
directed, and sometimes even if you do.

Methadone "can cause death" if not taken exactly as prescribed, the
federal Food and Drug Administration is now warning doctors and
patients who take the popular painkiller.

On Monday, the FDA issued a public health advisory for methadone,
titled "Methadone Use for Pain Control May Result in Death."

The agency also revised the drug's package insert saying how much
methadone is safe for pain patients to take. The old language about
the "usual adult dose" was potentially deadly, according to pain specialists.

The FDA's action comes after a six-month Sunday Gazette-Mail
investigation revealed that methadone helps to kill more people
nationwide than any other prescription narcotic. Some victims took
the medicine exactly as their doctors told them to, and they died anyway.

West Virginia led the nation in accidental overdose deaths blamed on
methadone in 2003, with a death rate four times higher than the
national average.

Federal officials knew about methadone's dangers for years, but
failed to strengthen the warnings about the drug until Monday.

After the Gazette-Mail investigation was published in June, Sen.
Chuck Grassley, R-Iowa, and Sen. Jay Rockefeller, D-W.Va., called on
the FDA to issue a stronger warning about methadone.

"This is a decision that should have been made many months ago,"
Rockefeller said Monday. "The FDA has a responsibility to American
consumers to oversee the use of all prescription drugs, including
methadone. Until now, their lax oversight of methadone has put the
lives of thousands of patients in West Virginia and across the
country in jeopardy.

"Today's decision means that doctors and patients will finally have a
clear warning about the dangerous side effects of methadone. That
knowledge will hopefully decrease the number of needless deaths and overdoses."

Last year, the FDA issued a public health advisory for fentanyl,
another narcotic painkiller, even though it causes fewer deaths than
methadone. In fact, the word "fatal" appeared 28 times in the
fentanyl package insert -- but not once in the methadone (brand name
Dolophine) insert.

Now, at the top of the new methadone patient information is a
black-box warning: "Do not take a higher dose of DOLOPHINE or take it
more often than prescribed," it warns in bold, underlined letters.
"This can lead to an overdose and possible death."

Methadone was once given mostly to heroin addicts to ease their
cravings. Recently, doctors have prescribed the drug to treat pain.
Insurance companies favor it because it is cheap and effective.

But methadone helped to kill three times as many Americans in 2003 as
it did in 1999, death certificates reveal, and medical examiners
blame it for more overdose deaths than any other narcotic except
cocaine, according to the Gazette-Mail investigation. Medical
examiners ruled 82 percent of those deaths accidental.

The FDA addressed several other findings of the Gazette-Mail
investigation: # The old package insert gave a "usual adult dose" of
2.5 to 10 milligrams "every three or four hours as necessary." That
could lead a patient to think 80 milligrams a day is safe, even
though studies have found that 50 milligrams or less can kill
patients who aren't used to strong painkillers, the Gazette-Mail
found. The FDA deleted that "usual adult dose" from the new patient
information.

"This is great news," said Dr. Lynn Webster, founder of a nonprofit
foundation devoted to eliminating drug overdose deaths. Webster has
traveled the country during the past year spreading the message about
the potential dangers of methadone.

"It is absolutely critical that this information get out," he said.
"Methadone is a powerful, effective, and lifesaving drug, but it is
potentially deadly if it is misused."

# The FDA issued 17 pages of new methadone-prescribing information
for doctors, including information about how long methadone remains
in the body - far longer than other painkillers, hanging around to
cause overdoses long after it has stopped killing pain.

# Methadone has killed patients who were taking other medicines,
including common anti-anxiety drugs such as Valium and Xanax. The new
information tells doctors and patients about this.

# Methadone can kill if the starting dose is too high. The new
information tells doctors to start patients on low doses of methadone
and keep a close eye on them.

# Popular conversion tables, widely published as guides for doctors
switching patients from various painkillers to methadone, are
imprecise and often incorrect. The new information warns doctors and
tells them to come up with a dosing schedule based on each individual's needs.

# Methadone can cause potentially fatal problems with heart rhythms.
The doctor who published those findings in several medical journals
told the Gazette-Mail that he was still trying to convince the FDA to
strengthen methadone warnings. The new information warns patients and
doctors about the potential for life-threatening heartbeat problems.

"I know they were aware of it and wanted to do something more
quickly," Dr. Raymond Woolsey said Monday. "They are grossly
underfunded ... The FDA doesn't have the resources to do its work."

Dr. Bruce Goldberger, director of toxicology at the University of
Florida Department of Medicine, was one of the first medical
examiners to talk about the growing number of methadone overdose
deaths, starting in 2002. In 2003, the FDA and other federal agencies
participated in a national conference on methadone overdose deaths.

"It's about time that the FDA did something about this," Goldberger said.

He hopes the number of methadone overdose deaths will decline, or at
least stabilize, as doctors and patients get the new information.
When the FDA issued its similar health advisory about fentanyl, the
number of deaths linked to that drug stabilized, he said.

"I'm pleased to see that the FDA has finally issued an advisory on
the use of methadone for the pain management population. However,
they knew about the problem in 2002, and here it's 2006. It's too
late for many victims."