Reporting of Pancreatic Cancer with Januvia, Byetta Urged in Israel
Israeli health officials are telling doctors in that country to be on the lookout for signs of pancreatic cancer among users of a popular class of diabetes drugs, known as incretin mimetics, which include the blockbuster medications Januvia and Byetta.
The move comes as health officials in the United States and Europe are evaluating the potential risk of pancreatic cancer with Janvuia, Byetta and other similar drugs in the same class, including Victoza and Janumet, the later of which combines Januvia with the older diabetes drug metformin.
The Israel Health Ministry called for doctors to pay attention to the link between users of incretin mimetics and pancreatic cancer after after determining that the number of reported cases in that country involving pancreatic side effects appeared to be lower than average, raising concerns that doctors may not be aware of the recent information suggesting users of Byetta, Januvia and other diabetes drugs may face an increased risk of pancreatic cancer.
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Israeli doctors have been urged to fill out an electronic form on the Health Ministry;s website if they see signs of pancreatic cancer, pancreatitis or other problems involving the pancreas among users of diabetes drugs.
Pancreatic Cancer Side Effects with Incretin Mimetic Diabetes Drugs
Incretin mimetics are a relatively new class of diabetes medications, which stimulate production of insulin when blood sugar is rising, and they stop the pancreas from releasing too much glucagon.
Byetta (exenatide) was the first member of the class, introduced in 2005 as a twice-daily Pen injection. Januvia (sitagliptin) was introduced the following year in pill form, and a combo therapy that includes metformin was introduced under the brand name Janumet. Victoza (liraglutide) was introduced in 2010 as a once-daily injection and other medications that are part of the class include Onglyza (saxagliptin) and Tradjenta (linagliptin).
Last month, the FDA launched an investigation into the potential incretin mimetics pancreatic cancer risk. The safety review was initiated after results of a recent study identified pre-cancerous cellular changes in pancreatic tissue taken from individuals treated with one of the drugs. European health officials have also launched a similar review.
According to a report released earlier this month by the Institute for Safe Medication Practices, more than 100 cases of pancreatic cancer from Byetta, Januvia, Victoza or other incretin mimetics were reported to the FDA during a 12 month period ending in June 2012. However, it is widely acknowledged that only between 1% and 10% of all adverse events associated with prescription medications are ever actually reported in the United States.
A growing number of Byetta lawsuits, Januvia lawsuits and Victoza lawsuits are now being filed in courts throughout the United States, alleging that the manufacturers of incretin mimetic diabetes drugs knew or should have known for years about the risk of pancreatic cancer, yet failed to adequately warn consumers or the medical community.
A motion is currently pending with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate and centralize all Byetta, Victoza, Januvia and Janumet pancreatic cancer cases filed throughout the federal court system before one judge for coordinated handling during pretrial proceedings.
At least 53 product liability lawsuits are already pending in 7 different U.S. District Courts, and product liability lawyers reviewing claims have suggested that hundreds, if not thousands, of additional lawsuits are likely to be filed in the coming months as additional information is learned about the pancreatic cancer risk with Byetta, Januvia, Janumet, Victoza and other incretin mimetics.
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