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.?
To contact staff writers Scott Finn or Tara Tuckwiller, use e-mail or call 357-4323 or 348-5189.