FDA Closes Door on Unapproved Pain Meds - Drug Abuse -Pain -

? Drug Abuse ? ? Pain ? Jul 06, 2012

Some oxycodone - a drug frequently in headlines of news articles about addiction - has been freely marketed without FDA approval, a problem that the agency is now trying to correct.

The FDA said today that it was giving makers of the unapproved oxycodone products 45 days to shut down sales.

The unapproved opioid drugs, sold in tablet, capsule, and liquid form, have been associated with some serious adverse events, likely because of inadequate labeling, according to FDA.

An FDA spokesperson did not return a request for comment regarding specific product names and manufacturers, but the agency said most of the drugs were put on the market before FDA drug approval standards were created.

Thus far, two serious adverse events associated with the products have been reported. In one instance, a 21-month-old received a prescription for a 1 mg/mL product but was given the 20 mg/mL formulation.

The child went into respiratory failure, but was resuscitated in the emergency department.

In the other case, an 18-year-old was told to take a teaspoon of the 5 mg/mL product every four hours but was also incorrectly given the 20-mg/mL dose. That patient suffered organ failure and went into a coma, and currently can speak but with a limited vocabulary, the FDA said.

Both errors were probably related to the similarity of the container labeling between the varying product strengths, the agency said.

In 2009, the FDA sent warning letters to nine companies making 14 unapproved narcotic drugs, including morphine, hydrocodone, and oxycodone. Some of the current oxycodone manufacturers were included in that warning, the agency said.

The list included Mallinckrodt, Vintage, and Endo, as well as Purdue - the manufacturer of one of the most common oxycodone formulations, OxyContin.

In the most recent warning, the companies were told to stop making the products within 45 days and to halt shipments within 90 days.

Ilisa Bernstein, acting director of compliance for FDA?s Center for Drug Evaluation and Research, said in a statement that since there are FDA-approved formulations of these painkillers available, there ?should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.?

The move is part of FDA?s campaign against unapproved drugs, which is largely an effort to ban prescription drugs that entered the market before federal law required FDA approval.

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By Kristina Fiore, Staff Writer, MedPage Today

Provided by ArmMed Media

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