Label Changes for:

Amitiza (lubiprostone) Capsules

April 2008

Changes have been made to the CONTRAINDICATIONS, 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

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Dyspnea

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Chronic Idiopathic Constipation
      • Table 1
      • Nausea
      • Diarrhea
      • Less common adverse reactions
    • Irritable Bowel Syndrome with Constipation
      • Table 2
      • Less common adverse reactions
  • Postmarketing Experience

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Geriatric Use
    • Irritable Bowel Syndrome with Constipation

NONCLINICAL TOXICITY

  • Carcinogenesis, Mutagenesis, Impairment of Fertility
    • Carcinogenesis
    • Impairment of Fertility

PATIENT COUNSELING INFORMATION

  • Dosing Instructions
  • Irritable Bowel Syndrome with Constipation

CONTRAINDICATIONS

Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS: Dyspnea

In clinical trials conducted to study Amitiza in treatment of chronic idiopathic constipation and IBS-C there were reports of dyspnea. This was reported at 2.5% of the treated chronic idiopathic constipation population and at 0.4% in the treated IBS-C population. Although not classified as serious adverse events, some patients discontinued treatment on study because of this event. There have been postmarketing reports of dyspnea when using Amitiza 24 mcg...

...These events have usually been described as a sensation of chest tightness and difficulty taking in a breath, and generally have an acute onset within 30-60 minutes after taking the first dose. They generally resolve within a few hours after taking the dose, but recurrence has been frequently reported with subsequent doses.

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