Regulatory Focus™ > News Articles > FDA: Stop Manufacturing Unapproved Oxycodone Products

FDA: Stop Manufacturing Unapproved Oxycodone Products

Posted 06 July 2012 | By Alexander Gaffney, RAC 

US regulators said they intend to take enforcement action against manufacturers of unapproved oxycodone products, saying the products constitute a "high public health priority" and have a high potential for misuse and abuse.

Oxycodone, an opioid commonly used as a painkiller, is a schedule II narcotic under the Controlled Substances Act (CSA), meaning it has a high probability of abuse despite its therapeutic uses.

FDA said it was made aware of unapproved single-ingredient, immediate-release, oral-dosage versions of the drug on the market through its Unapproved Drugs Initiative. Though there are approved versions of the formulation, FDA's 6 June Federal Register posting notes it is aware of several companies manufacturing the drug at unapproved doses and without proper marketing authorization.

'Particular Safety Concerns'

The combination of the drug's immediate-release formula, safety labeling omissions and possibly quality problems has the potential to harm consumers, FDA said in a statement.

"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," said Ilisa Bernstein, acting director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER).

"Unapproved new drug products containing oxycodone pose particular safety concerns because of their potential for addiction," FDA added in its Federal Register posting.

Additional concerns raised by FDA include potential confusion stemming from the unapproved product's name, formulation changes and adherence to current good manufacturing practices. The agency cited the example of a 21-month-old patient who was prescribed a 1mg/mL dose of Oxycodone, but instead received a 20mg/mL formulation which subsequently resulted in respiratory failure.

A second, similar case involving an 18-year-old patient receiving a 20-fold overdose of oxycodone resulted in organ failure, coma and a potentially permanent loss of speech. "These medication errors may have been due to the visual similarity of the container labels and carton labeling of the two product strengths," explained FDA.

FDA said all manufacturers of the products are expected to stop production within 45 days and sale of the products within 90 days. "Companies that continue to market products that fall within this scope of this Federal Register notice are subject to enforcement action including seizure, injunction, or other judicial or administrative proceeding," FDA added.


Read more:

FDA prompts companies to remove certain unapproved oxycodone products from market

Enforcement Action Dates: Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use


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