Label Changes for:

Relistor (Methylnaltrexone Bromide) Subcutaneous Injection

August 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –

August 2013

 

WARNINGS AND PRECAUTIONS

Gastrointestinal Perforation
  • Cases of gastrointestinal (GI) perforation have been reported in adult patients with opioid induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome)…

 

July 2010

WARNINGS and PRECAUTIONS

 

Intestinal Perforation
  • Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract: (e.g., stomach, duodenum, colon).
  • Use Relistor with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with Relistor and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.

ADVERSE REACTIONS

Postmarketing Experience
  • Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract: (e.g., stomach, duodenum, colon). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

PATIENT COUNSELING INFORMATION

What are the possible side effects of Relistor?
  • If you get diarrhea that is severe or does not stop while taking Relistor, stop taking Relistor and call your healthcare provider.
  • If you get abdominal pain that is severe or will not go away, or nausea or vomiting that is new or worse, stop taking Relistor and call your healthcare provider.

 

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