FDA approves painkiller designed to be more difficult to abuse, misuse

posted on:
April 12, 2010

author:
JENNIFER WALKER-JOURNEY

The Food and Drug Administration (FDA) has approved a new version of the painkiller OxyContin that is designed to be harder to abuse. OxyContin is a potent prescription narcotic pain reliever that slowly releases opioid oxycodone in patients who require around-the-clock medical management to treat moderate to severe pain. OxyContin is part of a class of painkillers known as opioids that includes morphine, Actiq and Fentora. Like all opioid narcotics, OxyContin can produce a sense of euphoria and thus puts patients at greater risk of addiction and dependence on the drug.

Over time, individuals have learned effective ways to tamper with OxyContin’s controlled-release technology by cutting, chewing, breaking or dissolving it. This can be very dangerous because it releases high levels of oxycodone all at once. The FDA has received reports of inadvertent overdose with OxyContin after health care practitioners crushed the drug in order to administer it to patients who could not swallow the tablet.

But individuals seeking OxyContin’s euphoric effects also tamper with the drug by crushing and snorting, or dissolving and injecting it. Those who tamper with the drug can end up taking higher doses of the medication than if they swallowed the tablet whole. As with any misuse of an opioid, this can have deadly results.

The reformulated version of OxyContin is intended to prevent immediate access to the full dose of oxycodone via cutting, chewing or breaking of the tablet. Dissolving the tablets in liquid results in a gummy substance that cannot be drawn up into a syringe or injected.

The FDA is ordering Purdue Pharma LP, makers of the new formulation OxyContin, to conduct a post-marketing study to determine the impact of the new formulation on the use and misuse of OxyContin. The FDA is also asking manufacturers to follow a Risk Evaluation and Mitigation Strategy for this product that includes a Medication Guide for patients and prescribers on the appropriate use of opioid analgesics in the treatment of pain.

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