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.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS

WARNINGS AND PRECAUTIONS

  • Serious Complications of Constipation
  • Ischemic Colitis
  • Prescribing Program for Lotronex

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Initial Paragraph
    • Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome
      • Table 2
      • Constipation

DRUG INTERACTIONS

  • Initial Paragraph

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
  • Geriatric Use
  • Hepatic Impairment
  • Renal Impairment

PATIENT COUNSELING INFORMATION

  • Physician and Patient Responsibilities

MEDICATION GUIDE

  • There is a special prescribing program for Lotronex.
  • What is Lotronex?
  • Who should not take Lotronex?
  • What should I talk about with my doctor before taking Lotronex?
  • What are the possible side effects of Lotronex?
  • How should I store Lotronex?
  • General information about the safe and effective use of Lotronex.

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.)

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