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Jim Heins

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Purdue Pharma Disputes DEA Analysis of Medical Examiner Reports


Stamford, CT - April 16, 2002 - Physicians from the U.S. Food & Drug Administration (FDA) and Purdue Pharma attended a meeting at the U.S. Drug Enforcement Administration (DEA) on April 12 to review for the first time the DEA’s interpretation of Medical Examiner reports on overdose deaths in which the analgesic oxycodone was present post mortem.  At the meeting, DEA presented an overview of past Medical Examiner reports received by the agency and suggested there had been an increase in the number of overdose deaths “attributed” to OxyContin® (oxycodone HCl controlled-release) Tablets.  The DEA has acknowledged, however, that these terms do not mean that OxyContin® was the cause of death.

Of the 949 complete Medical Examiner reports received by DEA covering a two-year period, 146 deaths were categorized by the DEA as “OxyContin verified” and 318 deaths were categorized as “OxyContin likely..  DEA acknowledged that the term “OxyContin verified” means only that the agency has concluded to its satisfaction that OxyContin was a source of the oxycodone present in the bloodstream — not necessarily the cause of death.  The term “OxyContin likely” is similarly used by the DEA to speculate on the source of the oxycodone found in the blood, but not on the cause of death.  The majority of post-mortem toxicology reports showed that multiple drugs were present. Purdue physicians strongly disagreed with the DEA's interpretation of these reports, which suffer from serious interpretive and methodological flaws that undermine the conclusions drawn.

Despite numerous requests by the company over the past year, the DEA has refused to share these Medical Examiner reports with Purdue, and declined on Friday to share the reports with the FDA — making it impossible to subject these reports to a proper scientific review by qualified experts. Purdue has already shared with the FDA the information the company has collected from a similar compilation of Medical Examiner reports and has repeatedly offered this information to the DEA.  The majority of the Medical Examiner reports received by Purdue as part of its regular drug safety monitoring concluded that polydrug toxicity, not any one drug alone, was the cause of death.

“While abuse of prescription medications, including OxyContin, poses serious health risks, including death, it is impossible to conclude and inappropriate to imply that OxyContin was the cause of death in the majority of cases characterized as ‘OxyContin likely’ or ‘OxyContin verified,’” said Paul Goldenheim, MD, senior physician and Executive Vice President of Worldwide Research and Development.  “And while there is no question that there have been deaths by overdose from the abuse of OxyContin, autopsy reports received by the company have confirmed that, in most cases, the deaths were due to polydrug toxicity.  Unfortunately, these reports reflect a pattern of drug abuse in the United States that results in thousands of such deaths every year.”

“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,” added Dr. Goldenheim.  “Testimony from medical experts and government officials at Congressional hearings and a recent FDA advisory committee meeting concluded that the benefits of OxyContin when used as directed clearly outweigh the risk associated with its intentional abuse.” 


The labeling for OxyContin contains the following warning:


OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

OxyContin Tablets are NOT intended for use as a prn analgesic.

OxyContin 80 mg and 160 mg Tablets are for use in opioid-tolerant patients only. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids. 

Oxycontin Tablets are to be swallowed whole and are not to be broken, chewed, or crushed. Taking broken, chewed, or crushed OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.


Full prescribing information for OxyContin is available at http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF

This and other recent announcements are available on the Purdue Pharma website at www.purduepharma.com.

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