New Opioid Painkiller Approved
FRIDAY, Oct. 1 (HealthDayNews) -- The U.S. Food and Drug Administration has approved Purdue Pharma's Palladone (hydromorphone hydrochloride) for people requiring 24-hour pain relief for an extended period.
The drug's active ingredients make it a schedule II controlled substance, which is the highest level of control for drugs with a recognized medical use, the FDA said in a statement. Some experts have been concerned about Palladone, since it is similar yet more potent than the widely abused medication OxyContin, also made by Purdue Pharma.
The agency said Purdue Pharma would try to limit the risk of illegal diversion by limiting promotion of the once-daily drug for the first 18 months, and by carefully tracking prescriptions.
The drug's packaging will include a so-called "black box" warning aimed at patients and doctors. The proviso will warn not only of the risk for abuse, but of a major side effect of overuse -- respiratory depression. This condition, often referred to as "shallow breathing," can cause severe respiratory problems and death.
To learn more about Palladone, see this FDA Talk Paper.
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