Study Raises Concerns About Diabetes Drug Risks

December 29, 2014 — An investigation by the Milwaukee-Wisconsin Journal Sentinel has found thousands of injuries and deaths linked to just a few new diabetes drugs.

About 30 diabetes drugs were approved by the FDA without proof that they reduce heart attacks or stroke, blindness, or other complications. Instead, they were approved based on other measures of effectiveness, such as reducing blood-sugar levels.

Investigators looked at the FDA database of adverse events between 2004 and March 2014. They found about 3,300 deaths and 20,000 hospitalizations in which diabetes drugs were suspected to be responsible.

Januvia (sitagliptin) was linked to 964 deaths and 4,425 hospitalizations. Byetta (exenatide) was linked to 880 deaths, but 7,115 hospitalizations. Victoza (liraglutide) was linked to 319 deaths and 2,827 hospitalizations.

Combined, these three drugs made up only 7% of the diabetes drug prescriptions in the United States, but over 50% of the deaths and hospitalizations linked to diabetes drugs last year.

Byetta, Januvia, and Victoza all belong to the same class of diabetes drugs — incretin mimetics — which work by mimicking digestive hormones that regulate blood-sugar levels. The FDA is investigating a number of recent studies suggesting these drugs may increase the risk of pancreatitis (pancreatic inflammation) and pancreatic cancer.

Over 500 lawsuits have been filed in federal court by people who were injured by Byetta, Januvia, or Victoza, accusing drug-makers of downplaying information about serious side effects. These lawsuits have been centralized in a Multi-District Litigation (MDL) under U.S. District Judge Anthony Battaglia in the Southern District of California.

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