FRIDAY, Nov. 2, 2001 (HealthDayNews) -- OxyContin, the powerful prescription painkiller, is responsible for 110 overdose deaths since last year and is the prime suspect in another 172 deaths, the Drug Enforcement Administration (DEA) says.
Previous DEA reports had focused on oxycodone, the active ingredient in OxyContin that is abused for its heroin-like high. But the increasing street popularity of OxyContin itself has prompted federal officials to start distinguishing between the prescription drug and its prime ingredient.
This is the first time the federal agency has studied the abuse of a brand-name drug.
"There's no real national data base available from medical examiner data on OxyContin," says Frank Sapienza, the head of drug and chemical evaluation for the DEA's Office of Diversion Control. "The data available from medical examiners is generally on generic substances found in the body -- in this case, oxycodone."
Sapienza says the DEA, as part of a an ongoing investigation, asked 775 medical examiners from 30 states for autopsy reports, toxicology information and investigations on oxycodone-related deaths since the beginning of 2000.
"We then looked if there was acetaminophen or aspirin, because other drugs like Percodan or Percocet combine oxycodone with aspirin or acetaminophen. And those were discarded," he explains. "So we ended up with 110 deaths that were verified as being caused by OxyContin, or OxyContin contributed to the death."
Thirty-three of the 110 deaths could be directly attributed to OxyContin use alone, Sapienza says. The other deaths showed combinations of OxyContin and other drugs -- alcohol, sedatives, other opiates or cocaine.
A spokesman for Purdue Pharma of Stamford, Ct., the drug's maker, says OxyContin can't be blamed alone.
The vast majority of the 110 overdose cases "involved multiple substances, often including alcohol," says Dr. Paul Goldenheim, Purdue Pharma's executive vice president of research and development. "And that creates a deadly cocktail. Abusers mix OxyContin with other things, like morphine or a variety of sedatives. Obviously, they take what they have, a handful of pills, crush them or swallow them or inject or inhale them."
OxyContin is legitimately prescribed for moderate to severe pain associated with cancer, chronic pain or serious injury. Available in four strengths, the drug has been formulated as a controlled-release tablet. Its pain-relieving effect lasts up to 12 hours -- making it longer lasting and stronger than other oxycodone products. Some 5.8 million prescriptions for OxyContin were filled in 2000, according to the DEA. "Abusers crush the dosage, which defeats the controlled release delivery system, and that gets them a rapid rush of dopamine in the brain," Goldenheim explains.
The DEA is somewhat leery of the combination theory.
"From examining our data, most of those who were alcohol-positive were at low levels or below intoxication," Sapienza says. "We looked at what drugs were found in combination with OxyContin in the bodies of the deceased, and we found that 40 percent contained the active ingredient in Valium or Xanax, 40 percent contained another opiate, and a fair amount, 13 percent, contained cocaine. This is the same pattern of combination of drugs found in heroin users, and it's not unusual to find mixtures of drugs."
Sapienza says OxyContin is "diverted from the legitimate chain of distribution, either at the doctor level or the pharmacy level." Abusers get the drug illegally by stealing prescription pads at doctors' offices and forging prescriptions, or stealing it from pharmacies, or visiting several doctors, often in different states, complaining of the same symptoms in order to obtain multiple prescriptions.
Reports to the contrary, Purdue Pharma does not distribute free samples of OxyContin to doctors, Goldenheim says.
"It's a Schedule II narcotic [narcotic drugs with a high potential for abuse but with currently accepted medical use in treatment]. What our program does is to allow appropriate patients, once the doctor has agreed that the drug may be efficacious, to try the drug through a voucher system. The patient takes the voucher to the pharmacist along with a prescription and gets a week's worth of medicine at no charge. That's standard practice in the industry."
Neither the DEA nor Purdue Pharma wants the abuse issue to cloud OxyContin's major role in pain management.
"We're trying to put this in some kind of perspective within the broad and very serious problem of prescription drug abuse," Goldenheim says. "I think the important thing here is that we have recognized over the last 10 years how large the pain problem is, here in this country. Fifty million Americans suffer from pain, and the medical community has learned that we have an obligation and the technologies and medicines to relieve suffering. We cannot turn the clock back now. We owe them our best medicines."
The DEA has several programs in place to combat OxyContin abuse, Sapienza says. "We're investigating, and we're taking action against those who sell or abuse the drug. And we are working with the pain management community to find ways to limit abuse."
"The DEA recognizes OxyContin is a very valuable drug when legitimate and prescribed for pain," says Rogene Waite, a DEA spokeswoman. "We are in no way trying to deny legitimate use of OxyContin."
What To Do
To gain access to the report on OxyContin, visit the U.S. Department of Justice.
The DEA and 21 major drug companies this week called for the creation of a balanced policy that protects the appropriate use of Schedule II pain relievers for patients who need them while also preventing abuse and illegal distribution of the drugs.
