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.
"Black Box Warning" 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 range of drug dosages between the minimum effective dose and the dose that produces unacceptable toxicity. Narrow therapeutic windows require careful dose monitoring.
More Clinical & Safety terms: Contraindication, Adverse Event, Therapeutic Window, Drug Interaction, Washout Period, Anaphylaxis, Immunogenicity, Anti-Drug Antibodies (ADA), MedWatch, REMS (Risk Evaluation and Mitigation Strategy), Gastroparesis, Pancreatitis, Gallbladder Disease, Injection Site Reaction, Sterile Abscess.