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Label Changes for:

Precose (acarbose) Tablets

March 2015

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

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

March 2015

PRECAUTIONS

Laboratory Tests
  • Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking acarbose. Use alternative methods to monitor for glycemic control.
     

 

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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