Prescribed methadone use comes with risks

Suffering from excruciating spinal deterioration, Robby Garvin, 24, of Beaufort, S.C., tried many painkillers before his doctor prescribed methadone in June 2006, just before Garvin and his friend Joey Sutton set off for a weekend at an amusement park.

On Saturday night, Garvin called his mother to say, “Mama, this is the first time I have been pain-free; this medicine just might really help me.”

The next day, though, he felt bad. As directed, he took two more tablets, and then he lay down for a nap. It was after 2 p.m. that Joey said he heard a strange sound that must have been Robby's last breath.

‘Unforgiving' medication

Methadone, once used mainly in addiction treatment centers to replace heroin, is today being given out by family doctors, osteopaths and nurse practitioners for throbbing backs, joint injuries and a host of other severe pains.

A synthetic form of opium, it is cheap and long-lasting, a pain reliever that has helped millions. But because it is also abused by thrill-seekers and badly prescribed by doctors unfamiliar with its risks, methadone is now the fastest-growing cause of narcotic deaths.

“This is a wonderful medicine used appropriately, but an unforgiving medicine used inappropriately,” said Dr. Howard Heit, a pain specialist at Georgetown University. “Many legitimate patients, following the direction of the doctor, have run into trouble with methadone, including death.”

Regulated dangers

Federal regulators acknowledge that they were slow to recognize the dangers of widespread methadone prescribing and to confront physician ignorance about the drug. They blame “imperfect” systems for monitoring such problems.

In fact, a dangerously high dosage recommendation remained in the Food and Drug Administration-approved package insert until late 2006. The agency has adjusted the label and is considering requiring doctors to take special classes on prescribing narcotics.

Between 1999 and 2005, deaths that had methadone listed as a contributor increased nearly fivefold, to 4,462, a number that federal statisticians say is understated since states do not always specify the drugs in overdoses. Florida alone, which keeps detailed data, listed methadone as a cause in 785 deaths in 2007, up from 367 in 2003. In most cases, it was mixed with other drugs like sedatives that increased the risks.

Methadone's history

The rise of methadone is in part because of a major change in medical attitudes in the 1990s, as doctors accepted that debilitating pain was often undertreated. Insurance plans embraced methadone as a generic, cheaper alternative to other long-lasting painkillers like OxyContin, and many doctors switched to prescribing it because it seemed less controversial and perhaps less prone to abuse than OxyContin.

From 1998 to 2006, the number of methadone prescriptions increased by 700 percent, according to DEA figures, flooding parts of the country where it had rarely been seen.

But too few doctors, experts say, understand how slowly methadone is metabolized and how greatly patients differ in their responses. Some prescribe too much too fast, allowing methadone to build to dangerous levels; some fail to warn patients of the potential dangers of mixing methadone with alcohol or sedatives, or do not keep in contact during the perilous initial week on the drug. And some patients do not follow the doctor's orders.

This year, the federal government started sponsoring voluntary classes that teach doctors the elaborate precautions they should take with methadone, like inching upward from low starting doses and screening patients for addictive behavior. (While Robby Garvin's doctor could argue that the dosage he was taking was reasonable – one to two 10-mg tablets, three times a day – and he was cleared by his state medical board, many specialists would have started him on a lower dose.)

In what critics call a stunning oversight, the FDA-approved package insert for methadone for decades recommended starting doses for pain at up to 80 mg per day. “This could unequivocally cause death in patients who have not recently been using narcotics,” said Dr. Robert Newman, former president of Beth Israel Medical Center in New York and an expert in addiction.

Changing labels

The FDA says that in the absence of reports of problems by doctors or surveillance systems, “we would have no reason to suspect that the dosing regimen” might need to be adjusted.

In November 2006, after reports of overdoses and deaths among patients multiplied and The Charleston Gazette reported on dangerous package instructions, the FDA cut the recommended starting limit to no more than 30 mg per day. “As soon as we became aware of deaths due to misprescribing for pain patients, we began the process of instituting label changes,” Rappaport said.

Methadone, made by Roxane Laboratories Inc. of Columbus, Ohio, and Covidien-Mallinckrodt Pharmaceuticals of Hazelwood, Mo., creates dependency and is sometimes sought by abusers who say they experience a special buzz when mixing it with Xanax.

While the greatest numbers of methadone-related deaths have occurred among the middle-aged, the fastest growth – an elevenfold jump between 1999 and 2005, to 615 – occurred among those age 14-24, which experts say may be mainly a result of pill abuse.