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Risks Associated With Januvia and Byetta Catching FDA’s Eye


diabetes insulin levelScientific studies have shown that certain types of diabetes drugs can increase the risk of pancreatitis and pancreatic cancer in users. This class of drugs, known as incretin mimetics, mimics the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. Along with diet and exercise, the drugs work to lower blood sugar levels in those suffering from type-2 diabetes. Drugs in this class include Januvia and Byetta.

In 2011, scientists at the University of California found that patients using Byetta or Januvia had three times the risk of developing pancreatic cancer when compared to controls who received other drugs to treat type-2 diabetes. Other animal studies and oncological research has also linked these drugs to pancreatic cancer.

The Food and Drug Administration (FDA) announced that it plans to investigate researchers’ findings that a group of diabetes drugs (including Januvia and Byetta) can cause an increased risk of pancreatitis and pancreatic cancer.

Researchers examined a small number of pancreatic tissue samples taken from patients treated with Januvia or Byetta after they died from unspecified causes. The study involved 2,538 adults with type-2 diabetes, and half of the subjects were hospitalized with acute pancreatitis. After adjusting external factors such as alcohol use, smoking, and obesity, researchers still concluded that patients who used Januvia or Byetta in the last 30 days had a higher risk of developing pancreatitis. In order to further examine the potential pancreatic effects associated with the drugs, the FDA has asked the researchers to provide it with their investigative process and the tissue samples.

While the FDA, doctors, scientists, researchers, and others have taken action ranging from withdrawal of these drugs to investigation of their deadly side effects, the Defendants have continued to enjoy financial success. Januvia sales topped nearly $1 billion in the first quarter of 2012 alone. Despite the scientific findings, the FDA has not yet concluded that these drugs cause or contribute to the development of pancreatic cancer.

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