Label Changes for:
Avodart (dutasteride) Soft Gelatin Capsules
Changes have been made to the CONTRAINDICATIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
PATIENT PACKAGE INSERT
...Avodart is contraindicated for patients with known hypersensitivity (e.g., angioedema) to dutasteride, other 5α-reductase inhibitors, or any component of the preparation.