Under Cephalon’s REMS, physicians who prescribe the drugs must complete an education module and knowledge assessment focused on safety information, such as appropriate patient selection.
The REMS begins enrollment in September. The FDA recently started requiring REMS for rapid-onset opioids to minimize risks of misuse, abuse and addiction.
Read the Cephalon release on its new safety strategy for pain drugs.
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Study: NSAIDs for Pain Bring Risks to Heart Patients
Study: NSAIDs May Blunt Effect of Antidepressants
Study: Prescription Drug-Related Harm Primarily Involved Opioids
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