7l5!2018 Postmarket Drug Safety Information for Patients and Providers Public Health Advisory: Methadone Use for Pain Control May Result in 

 

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Public Health Advisory: Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in
Breathing and Heart Beat -

The iSsues described in this communication have been addressed in product labeling,

please see Drugs@FDA 1
11/27/2006

FDA has received reports of death and life-threatening side effects in patients taking methadone. These deaths and life?
threatening side effects have occurred in patients newly starting methadone for pain control and in patients. who have
switched to methadone after being treated for pain with other strong narcotic pain relievers. Methadone can cause. slow or
shallow breathing and dangerous changes in heart beat that may not be felt by the patient.

Prescribing methadone is complex. Methadone should only be prescribed for patients with moderate to severe pain when
their pain is not improved with other non-narcotic pain relievers. Pain relief from a close of methadone lasts about 4 to 8
hours. However. methadone stays in the body much longer?from 8 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. Methadone may build up in the body to a toxic
level if it is take-n too often. if the amount taken is too high, or if it is taken with certain other medicines or supplements.

. To prevent serious complications from methadone, health care professionals who prescribe methadone should
read and carefully follow the methadone (Dolophine) prescribing information 2

FDA is issuing this public health advisory to alert patients and their caregivers and health care professionals to the following
important safety information:

. Patients should take methadone exactly as prescribed. Taking more methadone than prescribed can cause
- . breathing to slow or stop and can cause death. A patient who does not experience good pain relief with the prescribed
dose of methadone. should talk to his or her doctor.

 

. Patients taking methadone should not start or stop taking other medicines or dietary supplements without
talking to their health care provider. Taking other medicines or dietary supplements may cause less pain relief.
They may also cause a toxic buildup of methadone in the body leading to dangerous changes in breathing or heart bea'
that may cause death.

. Health care professionals and patients should be aware of the signs of methadone overdose. Signs of
methadone overdose include trouble breathing or shallow breathing; extreme tiredness or sleepiness; blurred vision;
inability to think, talk or walk normally; and feeling faint, dizzy or confused. If these signs occur, patients should get
medical attention right away.

FDA recently approved new prescribing information for methadone products approved for pain control. The information in thi
new prescribing information is based on a review of the scientific literature completed by FDA. A Medication Guide for
patients is planned.

 

Related Information

. Dolophine (methadone hydrochloride.) Prescribing Information Nov 20063
- Methadone Hydrochloride (marketed as Dolophine) Prescribing and Label Information?

Contact FDA
1?800-332-1088
Fax
Report a Serious Problem

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7512018 Postmarket Drug. Safety Information for Patients and Providers Public Health Advisory: Methadone Use for Pain Control May Result in I

Regular Mail: Use postage-paid FDA Form 35006
Mail to: MedWatch 5600 Fishers Lane
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