FDA Opioid Analgesic Labeling Guidance Will Highlight Drug Abuse Potential

FDA is developing a guidance on labeling for opioid analgesics, designed to highlight the abuse risk of the drugs.

The agency is analyzing labeling for opioid analgesics to identify common problems, including outdated drug abuse warnings, inconsistent instructions for overdoses, vague or understated indications and clinical trial data that does not support efficacy findings.

The findings will be used in developing the draft version of the guidance, which is expected by the end of 2001.

The main purpose of the guidance is to help bring attention to the potential for opioid drug abuse, misuse and diversion.

FDA is encouraging manufacturers to voluntarily submit revised labeling for opioid analgesics to the agency.

"Since all opioids are subject to abuse, misuse and diversion, FDA is encouraging all manufacturers of opioids sold in the U.S. to review voluntarily, and revise as necessary, their product's labeling to provide adequate warnings and precautions regarding these risks and to promote responsible prescribing practices," a July 25 "Talk Paper" states.

FDA issued the "Talk Paper" to announce the addition of a black box warning to labeling for Purdue Pharma's OxyContin (oxycodone) (¹ ). OxyContin is the first opioid to carry a black box warning in labeling.

The agency said that not all opioid analgesics will have to carry a black box warning, depending on the abuse potential for each product.

A patient question and answer sheet for OxyContin posted on FDA's web site advises patients taking OxyContin to destroy any leftover tablets after their physician instructs them to cease taking the medication. The agency is considering including similar information in a patient package insert for OxyContin.

FDA also plans to prepare a separate guidance for reformulated opioid analgesic products, such as an abuse-resistant opioid analgesic being developed by Purdue.