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 veggie
Registered: 07/25/04
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 FDA issues methadone warning
#6325638 - 12/01/06 08:52 PM (1 year, 7 months ago) |
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FDA issues methadone warning
December 1, 2006 - thefranklinpress.com
The U.S. Food and Drug Administration issued a public health advisory this week for the prescription pain medicine methadone, warning patients and doctors the drug can kill or cause dangerous changes in the heartbeat and breathing.
Reports of overdose deaths and life-threatening side effects among patients who took the medicine to combat chronic pain prompted the alert according to the FDA release. The statement said side effects could occur because "methadone may build up in the body to a toxic level if it is taken too often, if the amount taken is too high, or if it is taken with certain other medicines or supplements."
Since 2001, methadone has been linked to 12 fatalities in Macon County according to death certificates filed in the Macon County Register of Deeds office. Four of the methadone deaths here occurred this year.
Methadone misuse has been particularly prevalent among younger persons in Macon County, as eight of the 12 who died were under the age of 40, including an 18-year old and a 19-year old.
Dr. Charlie Vargas, who works for Angel Hospice, said due to his position he has received notice of FDA's advisory on methadone. He said the timing of the warning makes him skeptical about the situation.
"It's (methadone) been around so long," Vargas said. "It's a little suspect."
Methadone has generally been regarded as a cheap, safe and effective drug for people who have multiple pain complications, Vargas said.
He said that in his profession, while not the "go to medicine" methadone is "a great one to go to when other medications don't work."
Methadone had been a preferred choice among doctors because it does not cause a high as some other narcotic painkillers do.
"The problem with methadone is that people don't feel it take affect," Vargas said.
As a result, Vargas said that monitoring methadone patients requires a careful, collaborative and thorough process involving a lot of teaching.
He said that education and training of family and staff are important factors in ensuring that methadone patients are watched closely.
"This is something we can fix," said Kay Sanford, an epidemiologist with the North Carolina Division of Public Health who has studied the increase in unintentional methadone deaths.
She commented that it would take two groups-doctors and patients working together-to reverse the alarming trend.
For doctors, it comes down to closely monitoring their patients and teaching them how to use the drug in appropriate doses and the danger of not following prescriptions, Sanford said.
Sanford said the reason for the caution is that methadone does not cause a high and patients display no outward effects except drowsiness.
A person who dies of an overdose from methadone generally just stops breathing and dies, Sanford said.
In regards to patients, Sanford said they must learn how to use methadone and make certain to keep it away from children and other people to whom it has not been prescribed.
Sheriff Robert Holland said his officers have typically found that those who died from a methadone overdose did not have a prescription, but he has seen instances of those who did have a prescription as well.
He said there has been no case involving a methadone overdose (where it had not been prescribed) where they have been able to press charges.
"It is difficult to prove who gave them the drug," Holland said. He also stressed the significance of educating people about the drug. "The key thing is an awareness of how dangerous it is," Holland said.
From 2000 to 2005, methadone has caused or contributed to the deaths of 1,086 people in North Carolina according to Sanford.
Sanford said that basically two drugs-methadone and cocaine, run neck and neck as the leading killer in North Carolina for those who accidentally overdose on a drug, causing or contributing to 50 percent of the deaths.
She qualified though that approximately one-third of the accidental drug-related deaths involved a combination of drugs.
Sanford said it was important though that people not demonize methadone, since it can save lives when prescribed correctly.
She said part of the problem with methadone is that it is an old drug and not much literature is available.
Invented in Germany in the 1930s, doctors and clinics used methadone as a safe means of getting people over heroin addiction, although it is now also utilized as a painkiller.
Another challenge of the drug is that what is an overdose amount for one patient may not be so in another patient, Sanford said.
A new user might require a low dosage whereas a substance abuser taking it for maintenance purposes could need a higher amount. Moreover, someone who has been on methadone for years could have built a tolerance and require an increased dosage.
Sanford released a study in 2002 that cited an increase in unintentional drug overdose deaths from prescription narcotics such as methadone, morphine, oxycodone and fentanyl.
"We've known about this and we've been working steadily to try to make the problem more known," Sanford said.
She added that they have been working with teenagers and those most vulnerable to educate them on methadone and help reduce the trend.
Vargas said he still has unanswered questions he liked to investigate about the FDA's advisory.
"All of the sudden we have cardiac problems with an old drug." " Where does this come from?"
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