Medication Guide App

Label Changes for:

Precose (acarbose) Tablets

February 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2011 and February 2012

 

February 2012 

 

ADVERSE REACTIONS

Postmarketing Adverse Event Reports
  • Pneumatosis Cystoides Intestinalis: There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with the use of alpha-glucosidase inhibitors, including Precose. Pneumatosis cystoides intestinalis may present with symptoms of diarrhea, mucus discharge, rectal bleeding, and constipation. Complications may include pneumoperitoneum, volvulus, intestinal obstruction, intussusception, intestinal hemorrhage, and intestinal perforation. If pneumatosis cystoides intestinalis is suspected, discontinue Precose and perform the appropriate diagnostic imaging.

 

March 2011

 

ADVERSE REACTIONS

  • thrombocytopenia, pneumatosis cystoidis intestinalis, and fulminant hepatitis with fatal outcome

 

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