The type 2 diabetes drugs Januvia (sitagliptin phosphate) and Byetta (exenatide) have been associated with 1,844 deaths and 11,540 hospitalizations, according to a MedPage Today and Milwaukee Wisconsin Journal Sentinel analysis of health care provider and pharmaceutical company adverse event reports.
“Under the FDA’s system, drug companies are required to file (drug-related adverse event) reports – but patients and doctors often don’t report incidents to the drug makers. In addition to health care providers, patients can report the incidents directly to the FDA. The database may include duplicates – though the last time the federal Government Accountability Office did a comprehensive review of the data, in 2000, it estimated fewer than 10 percent of all incidents are reported to the FDA,” the Journal Sentinel reported.
The report lists 30 diabetes drugs, the year each was approved, and the number of suspected drug-related deaths and hospitalizations associated with each. The list includes several of the newer type 2 diabetes treatments, which are grouped in a class known as incretin mimetics. Januvia tops the list with 964 deaths and 4,425 hospitalizations, with Byetta coming in a close second with 880 deaths and 7,115 hospitalizations. Victoza is a distant third with 319 deaths and 2,827 hospitalizations.
While the adverse events that led to the deaths and/or hospitalizations are not defined, the drugs carry potentially life threatening side effects, including cancer risks. Incretin mimetics have been linked to a painful inflammation of the pancreas known as acute pancreatitis. The drugs have also been linked to an increased risk of pancreatic cancer, one of the most deadly forms of cancer. The incretin mimetics that carry the greatest risk to the pancreas are Januvia and Byetta.
Several lawsuits have been filed against the makers of these drugs by patients or their family members who say the drug companies knew of the cancer risks with their type 2 diabetes treatments but failed to warn consumers of this risk.