Drugs

New Safety Measures Announced for Immediate Release (IR) Opioids

[9/18/2018] FDA approved the Opioid Analgesic REMS, which applies to all opioid analgesics intended for outpatient use. The REMS program requires that training be made available to all health care providers who are involved in the management of patients with pain, including nurses and pharmacists. The agency also approved the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (Blueprint), as well as safety labeling changes that require companies to include new safety information regarding the Opioid Analgesic REMS in the Boxed Warning and Warnings and Precautions sections of prescribing information.

[6-1-2018] FDA sent safety labeling change notification letters to drug companies with approved opioid analgesic products intended for use in an outpatient setting. The letters require these companies to include new safety information regarding the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) in the Boxed Warning and Warnings and Precautions sections of prescribing information due to a general lack of awareness of the REMS among all opioid analgesic prescribers.

[3-22-16] In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse and abuse, which can lead to addiction, overdose and death. Today’s actions are among a number of steps the Agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective relief.

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications.  This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.

 

March 22, 2016

 

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