Summary Safety Review - DPP-4 inhibitors (gliptins) - Assessing the Potential Risk of Gastrointestinal Blockage (Gastrointestinal Obstruction)
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2016-11-14
Product
DPP-4 inhibitors (gliptins)
Potential Safety Issue
Gastrointestinal blockage (gastrointestinal obstruction)
Overview
Use in Canada
- In addition to diet and exercise, DPP-4 inhibitors, known as gliptins, are used alone or with other anti-diabetic drugs, to help improve blood sugar control in adult patients with type 2 diabetes. There are currently 4 different gliptins on the Canadian market: sitagliptin, saxagliptin, linagliptin and alogliptin. These drugs are also available in products that combine them with other drugs that treat type 2 diabetes.
- Sitagliptin was the first gliptin sold in Canada in 2008. In 2015, about 3 million prescriptions of sitagliptin were filled in Canada.
Safety Review Findings
- At the time of the review, 39 international and 1 Canadian reports of gastrointestinal obstruction in patients who used a gliptin were assessed. Of the 40 reports, the gliptin was found to be possibly linked to the gastrointestinal obstruction in 11 international reports (6 with sitagliptin, 3 with alogliptin and 2 with linagliptin). However, with these 11 cases, there were other potential causes of gastrointestinal obstruction which made it difficult to conclude that the obstruction was caused by gliptins alone.
- The review of the literature did not show enough information to support a link between gliptin use and gastrointestinal obstruction.
Conclusions and actions
- Health Canada's review concluded that the evidence does not support a link between gliptin use and gastrointestinal obstruction.
- Health Canada will continue to monitor side effect information involving gliptins, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate action if and when any new health risks are identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.