An FDA-required safety program for medications with serious safety concerns. Ensures benefits outweigh risks through prescriber certification, patient agreements, or restricted distribution.
"REMS (Risk Evaluation and Mitigation Strategy)" is filed under Clinical & Safety in the PeptideAtlas glossary, alongside 15 other terms in that group.
A condition or factor that makes a particular treatment or procedure inadvisable. Absolute contraindications mean the treatment should never be used; relative contraindications mean the benefits may outweigh risks in some cases.
Any undesirable experience associated with the use of a medical product, whether or not considered related to the product. Serious adverse events include hospitalization, disability, or life-threatening outcomes.
The FDA's most serious warning placed on a drug's prescribing information, indicating significant risks of serious or life-threatening adverse effects. GLP-1 agonists carry a black box warning for thyroid C-cell tumors based on rodent studies.
More Clinical & Safety terms: Contraindication, Adverse Event, Black Box Warning, Therapeutic Window, Drug Interaction, Washout Period, Anaphylaxis, Immunogenicity, Anti-Drug Antibodies (ADA), MedWatch, Gastroparesis, Pancreatitis, Gallbladder Disease, Injection Site Reaction, Sterile Abscess.