FDA Announces New Warning for Methadone Patients

According to the U.S. Food and Drug Administration, patients treated with methadone are susceptible to life-threatening alterations in their breathing and heartbeat–and, in some cases, even death. The FDA issued its latest health advisory yesterday, warning patients of potential problems if their methadone intake isn’t strictly monitored.

“FDA has received reports of death and life-threatening side effects in patients taking methadone,” says the advisory. “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 heartbeat that may not be felt by the patient.”

The FDA recommends that methadone patients take the drug exactly as prescribed and that they do not take other drugs or supplements before consulting a doctor. They are also urging patients and health-care professionals to be aware of signs of methadone overdose: trouble breathing or shallow breathing; extreme tiredness or sleepiness; blurred vision; inability to think, talk, or walk normally; and feeling faint, dizzy or confused.

The FDA also advises that “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 dose 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 taken too often, if the amount taken is too high, or if it is taken with certain other medicines or supplements.”

Methadone is responsible for thousands of unintended deaths–more than 2,000 deaths in the year 2003 alone. That year, roughly 2 million prescriptions were filled for methadone.

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