Label Changes for:
Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions, including drug-induced hepatitis; previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid such as drug fever, chills, arthritis; and acute liver disease of any etiology.
- Addition of the following: and pancreatitis.
- Addition of the following: toxic epidermal necrolysis, and drug reaction with eosinophilia syndrome (DRESS).