Summary Safety Review - DPP-4 inhibitors (gliptins) - Assessing the Potential Risk of Gastrointestinal Blockage (Gastrointestinal Obstruction)

November 14, 2016

Product

DPP-4 inhibitors (gliptins)

Potential Safety Issue

Gastrointestinal blockage (gastrointestinal obstruction)

Key Messages

  • DPP-4 inhibitors, known as gliptins, are prescription drugs used to treat type 2 diabetes.
  • This review was initially triggered by international reports of gastrointestinal obstruction in patients who used the drug sitagliptin. The review was then extended to include all gliptins available in Canada.
  • Health Canada's safety review concluded that there is not enough information available at this time to confirm a link between gliptin use and gastrointestinal obstruction. Health Canada will continue to monitor the safety of gliptins.

Overview

A safety review was carried out by Health Canada to evaluate the potential risk of gastrointestinal obstruction with the use of DPP-4 inhibitors after international reports of gastrointestinal obstruction were found in patients who used a gliptin called sitagliptin.

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.

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