The prescription painkiller
OxyContin may have played a role in 464 overdose-related deaths over
the past two years, a rate much higher than previously reported,
according to the Drug Enforcement Administration (DEA) in an ongoing
study of autopsy reports related to oxycodone or the product,
OxyContin.
OxyContin, an opiod pain
reliever, has been the subject of much media attention, due to its
potential for abuse, addiction, and diversion. Opiod analgesics are
a class of national and synthetic medication that relieves moderate
to severe pain and is used for cancer, severe forms of arthritis and
chronic pain syndromes.
Last year, the DEA
contacted 775 medical examiners nationwide and asked them to submit
autopsy, toxicology, and medical examiner investigative reports from
2000 and 2001 for deaths associated with oxycodone, an active
ingredient found in OxyContin and other painkillers (see ADAW,
Nov.19, 2001).
In its previous review of
autopsy data, the DEA said that OxyContin could have been
responsible for 282 overdose-related deaths.
Of the 949 complete medical
examiner reports received, 146 deaths were categorized as "OxyContin-verified"
deaths and 318 were categorized as "OxyContin-likely." The DEA
categorized the remainder of the reports as undetermined deaths,
because they were not able to determine if OxyContin was involved.
According to the DEA, there
are currently a limited number of single entity oxycodone products
that do not also contain the pain relievers acetaminophen or
salicylates (aspirin). Any oxycodone-positive toxicology without the
presence of acetaminophen or salicylates was categorized as an "OxyContin-likely"
death.
The oxycodone-positive
autopsy reports that described tablet contents in the
gastrointestinal tract and which could be identified as OxyContin
were recategorized by the DEA as "OxyContin verified" deaths. The
DEA scrutinized for the presence of an OxyContin prescription or
tablet at the crime scene, on the person, or reported to be consumed
by the diseased, by a family member or other credible witness
present at death.
The report indicated that
of the 7.2 million prescriptions single-entity oxycodone products
sold in 2000, approximately 5.8 million were for OxyContin.
Until recently, OxyContin
toxicity was not listed as a cause of death, said the report.
Medical examiners used to classify deaths by drug substance only.
Since its request, the DEA now receives more medical examiner
reports that list OxyContin overdose as the specific cause of death.
Findings Disputed
Purdue Pharma L.P., the manufacturer
of OxyContin, disputed the DEA's interpretation of the medical
examiner reports. "While any death is tragic, Purdue believes that
almost none of these reports involves overdoses by patients with
legitimate medical needs using the medicine as prescribed under
the treatment of a healthcare professional," said Paul Goldenheim,
M.D. senior physician and executive vice president of worldwide
research and development at Purdue Pharma.
According to Tim Bannon,
senior director of public affairs at Purdue Pharma, the DEA's
report did not reach a sound conclusion. "The presence of
oxycodone in and of itself doesn't mean that OxyContin was its
source," Bannon told ADAW. "The DEA has drawn a conclusion
that really is not correct," he added. "If you find oxycodone and
59 products contain it, you can't conclude it was OxyContin," said
Bannon.
According to the DEA
report, of the 464 deaths linked or most likely linked to
OxyContin, 88 [of those deaths] had quantifiable levels of blood
alcohol at the time of death. In addition, nine deaths were
associated with the presence of a "recent injection site," and one
death was associated with snorting the drug. The vast majority of
the deaths were associated with oral consumption of the tablet.
"One death is too many,
with the proper use or improper use of medicine," Howard Heit,
M.D., co-chair of the American Society of Addiction Medicine
National Pain Committee, told ADAW. "Chronic pain is the
number one complaint presented to doctors in this country.
OxyContin when used properly is a good medicine and a valid
treatment for pain."
Heit, who has a private
practice in addiction and chronic pain management in Fairfax, Va.,
said he is speaking on his own behalf and that his comments do not
reflect his professional affiliations. "Speaking as a practicing
physician, the DEA report is not based on credible evidence and
could not be accepted in a peer-reviewed journal or in a court of
law," Heit said.
Heit said the media has
acted irresponsible and has influenced the younger generation's
abuse of OxyContin. "The media has taught the younger generation
how to abuse OxyContin," said Heit. "This has led to the fear by
doctors to prescribe valid medicines and legitimate pain
prescriptions approved by the FDA during the course of their
professional activity."
Heit said it is important
to go over the risks, benefits, and pros and cons of any
medication and that it should be prescribed with the full,
informed consent of the patient. "Treating pain is not just about
writing a prescription," said Heit. "You have to evaluate the
person; do they have a history of depression, bipolar disorder,
addiction for themselves, or a family member? It may make the use
of opiates more risky."
FDA Response
A U.S. Food and Drug Administration
(FDA) official told ADAW that agency officials plan to
meet with DEA officials to review the methodology and
conclusions of the report. "Our feelings are that the report
does not indicate that there are any problems with the safety of
the drug as long as the patients take it as indicated -- when
people take it in the context of abuse, it can be very unsafe,"
said Cynthia McCormick, M.D., director of the FDA's Division of
Anesthetics, Critical Care and Addiction Drug Products in its
Center for Drug Evaluation.
Alcoholism & Drug Abuse
Weekly 14(18):1, 2, 2002.
