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: