Use Caution When Prescribing Methadone for Pain, Says FDA

Slow titration, close monitoring and, above all, clear communication with patients to take only the prescribed amount are imperative if clinicians are to safely prescribe methadone for pain control, according to the FDA.

In a November public health advisory, the FDA emphasized that life-threatening side effects, such as shallow or slowed breathing and changes in heartbeat, and even death can occur among patients taking methadone, marketed as Dolophine. These effects may be seen even in patients who are opioid-tolerant.

"These serious side effects may 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," says an online FDA information page on the alert.

The medication, which is approved by the FDA for controlling symptoms of withdrawal from narcotic drugs, also is prescribed to treat moderate to severe pain in patients who don't respond to nonnarcotic pain medicine.

"Pain relief from a dose of methadone lasts about four to eight hours," the advisory says. "However, methadone stays in the body much longer -- from eight to 59 hours after it is taken. As a result, patients may feel the need for more pain relief before methadone is gone from the body."

The FDA information page links to patient information (PDF file: 4 pages / 29 KB. More about PDFs.) that addresses the potential life-threatening side effects of methadone use, describes reasons for taking the medication and explains that patients must take the drug exactly as prescribed. Also included are an information sheet for physicians and prescribing information. (PDF file: 21 pages / 135 KB. More about PDFs.)

According to the FDA, physicians who prescribe methadone for patients' pain need to