July 25, 2001 - FDA Strengthens Warnings For OxyContin
Drug Enforcement Administration (DEA) lists OxyContin as a Schedule II controlled substance as defined by the Controlled Substances Act (CSA) and allows the maximum amount of control possible for this drug. OxyContin is a pain reliever and its molecular structure is similar to that of morphine, thus making it potentially just as addictive and dangerous. It can even be deadly if the tablet is reduced to powder and snorted instead of being taken orally. Recently, a number of controlled substance reports from all over the United States have alerted the Food and Drug Administration that OxyContin is often abused, misused, or diverted.
In response to this growing problem, the FDA updated the requirements for the warnings and precautions sections of labels to warn users of potentially severe health hazards of OxyContin (oxycodone HCl controlled-release) Tablets. The label now has the strongest type of warning for an FDA-approved drug - a "black box warning" - insuring that the drug will be offered only to appropriate patients suffering from severe pain.
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