Authors writing on behalf of the FDA for Healio urge clinicians to stay informed about Risk Evaluation and Mitigation Strategies (REMS) for pharmaceuticals.
REMS programs can address a drug’s potential risks through a range of tools. One example might involve a known drug side effect — life-threatening infections.
FDA could require a REMS that helps ensure patients are aware of the initial signs of this infection and can seek treatment before the infection becomes severe. In a case in which a drug could cause a severe allergic reaction immediately after administration, a REMS might require that health care professionals agree to observe the patient for a period of time after the initial dose.
Some REMS might require ongoing monitoring. For example, if a drug can cause liver injury or failure, regular studies that evaluate liver function may be required.
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