FDA Orders Unapproved Oxycodone Drugs Halted

Its notice in the Federal Register affects companies that manufacture and distribute unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules, and oral solutions.

The U.S. Food and Drug Administration has published a notice ordering companies to stop manufacturing and distributing some unapproved drugs that contain oxycodone. The agency said this step is part of its Unapproved Drugs Initiative to remove unapproved new drugs from the market.

The affected drugs -- single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules, and oral solutions -– haven't been evaluated by FDA for safety, effectiveness, manufacturing quality, or appropriate labeling. Oxycodone is listed under Schedule II of the Controlled Substances Act with an abuse liability similar to other opioid agonists.

The notice says FDA is aware of unapproved 5 mg capsules and unapproved oral solutions in 5 mg/5 mL and 20 mg/mL strengths. It also is aware of two adverse events cited in the notice: a 21-month-old patient prescribed oxycodone at a strength of 1 mg/mL but instead given one at 20 mg/mL who suffered respiratory failure but was successfully resuscitated, and an 18-year-old patient whose prescription was to take one 5 mg teaspoon every four hours but was given a 20 mg/mL solution. This second patient went into a coma with organ failure and was placed in intensive care, and at the time of the report to FDA "was able to speak but only with a limited vocabulary," according to the notice.

"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. "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."

Companies are expected to stop making the products within 45 days and stop shipping them within 90 days. Affected products were introduced onto the market before Sept. 19, 2011, were listed in FDA's Drug Registration and Listing System before July 6, 2012, and were being commercially used or sold before July 6, 2012.

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