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FDA Committee Recommended Against Oxycodone-Niacin Combo
The FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety & Risk Management Committee voted not to recommend approval of oxycodone HCl and niacin, a combination medication that was developed to deter abuse of oxycodone, according to a MedPage Today article. The drug was designed to resist tampering by crushing, and to deter abuse of oxycodone through the addition of niacin which can cause flushing in high concentrations. While they supported the intention of the drug manufacturer, committee members cited the need for more convincing data from the manufacturer. Some members questioned the effectiveness of niacin as a deterrent to abuse, and others noted the negative impact of an additional side effect on certain patients.
