Label Changes for:
Lotronex (alosetron hydrochloride) Tablets
April 2008
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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 |
|
BOXED WARNING
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
MEDICATION GUIDE
|
BOXED WARNING WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS ...Only physicians who have enrolled in the Prometheus Prescribing Program for Lotronex based on their understanding of the benefits and risks, should prescribe Lotronex... WARNINGS AND PRECAUTIONS Serious Complications of Constipation ...Complications of constipation have been reported with use of 1 mg twice a daily and with lower doses. A dose response relationship has not been established for serious complications of constipation... Ischemic Colitis Some patients have experienced ischemic colitis without warning... ...Ischemic colitis has been reported with use of 1 mg twice daily and with lower doses. A dose-response relationship has not been established. Ischemic colitis was reported in one patient receiving placebo. Prescribing Program for Lotronex (See highlighted text for labeling revisions.) |
