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FDA Calls for Halt to Unapproved Drugs Containing Oxycodone

Pauline Anderson

Posted: 07/05/2012

July 5, 2012 — The US Food and Drug Administration (FDA) has issued a Federal Register notice to halt the manufacture and distribution of unapproved single-ingredient immediate-release drugs that contain oxycodone.

Such products have not been evaluated by the FDA for safety, effectiveness, manufacturing quality, or appropriate labeling, including dosing information and warnings, and cannot be legally marketed in the United States, the FDA states in a press release.

“It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the FDA statement.

“Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.”

Improper labeling and use of oxycodone can lead to overdose and death. Opioid medications are associated with prescription drug misuse, abuse, and addiction, which have resulted in an increase in injuries and deaths across the United States over the last 10 years.

Companies with products that are subject to this action are expected to stop manufacturing the products within 45 days and to stop shipping the products within 90 days. Those that continue to market products falling within the scope of this notice are subject to enforcement action, including seizure, injunction, or other judicial or administrative proceedings, according to the FDA.

The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved drugs from the market, the statement notes.

Healthcare professionals and consumers may report adverse side effects or medication errors from the use of prescription drug products to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.