Purdue Pharma Restates Physician Prescribing
Information for OxyContin® Tablets
Stamford, CT
- July 25, 2001 - Purdue Pharma L.P. has made changes to the
physician prescribing information for OxyContin®
(oxycodone HCI controlled-release) Tablets as part of the company's
efforts to help reduce the serious problem of abuse and diversion of
the prescription pain medication. These voluntary changes were
developed in cooperation with the U.S. Food and Drug
Administration. The FDA is requesting that all manufacturers of
opioid analgesics review their labeling and voluntarily make similar
changes to their package inserts.
"We believe these changes to our package insert will further enhance our efforts to minimize abuse and diversion of OxyContin® Tablets, while continuing to ensure that legitimate patients continue to have access to this medication," stated Michael Friedman, Chief Operating Officer of Purdue Pharma. "While we believe that the prior package insert provided accurate and proper information about the drug, given the recent serious problem of abuse and diversion of the product in some areas of the country, the company believes it is appropriate to make these changes at this time. We urged the FDA to join with us in calling for all manufacturers of opioid analgesics to make similar package insert changes in recognition of the growing problem of prescription drug abuse. I am pleased that Purdue is the first analgesic manufacturer to voluntarily make these changes. We are calling upon other makers of opioid analgesics to follow Purdue's lead." Purdue sent a letter last week to more than 800,000 healthcare professionals outlining the revisions of the prescribing information for OxyContin®. The revised package insert is also available on the company's website at www.purduepharma.com. The package insert is the standing reference for healthcare professionals for information on prescription medications. It includes the FDA-approved indication for use, data from clinical trials, adverse effects and warnings. Highlights of the changes to the OxyContin® package insert include:
- A new boxed warning at the beginning of the insert that calls attention to its potential for misuse, abuse and diversion. The information in the boxed warning is drawn from parts of the original package insert.
- The indications section has been reworded to reinforce the appropriate patient population for whom OxyContin® is intended. The new wording is as follows: 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.
