The FDA's MedWatch program compiles a quarterly report of important changes to safety labeling for boxed warnings for drugs and therapeutic biologics.
Boxed warnings highlight:
Adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; OR
Serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; OR
FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.
Label changes are searchable in the Drug Safety Labeling Changes (SLC) database.
Deutetrabenazine (Austedo)
For more on this Drug Safety Labeling Change, click here.
For full prescribing information, click here.
Updated Boxed Warning
WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON'S DISEASE
AUSTEDO can increase the risk of depression.
Public Information from the FDA and Medscape
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Cite this: Drug Safety Warnings and Updates: April-June 2018 - Medscape - Sep 10, 2018.
