Pharmaceutical

FDA, EMA still investigating pancreatic problems with diabetes drugs Byetta, Januvia

januvia sitagliptin FDA, EMA still investigating pancreatic problems with diabetes drugs Byetta, JanuviaU.S. and European drug regulators have yet to reach a final conclusion about whether a widely prescribed class of type 2 diabetes drugs increases the risk of pancreatic problems. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched separate investigations a year ago into the safety of so-called incretin mimetics drugs such as Januvia and Byetta after studies linked the medications to acute pancreatitis and pancreatic cancer.

Incretin mimetics, which include GLP-1 receptor agonists and DDP-4 inhibitors, work by increasing the release of insulin after meals and by slowing the absorption of food in the gastrointestinal tract. Nine of these drugs are approved in Europe and seven in the U.S. The drugs have been on the market for less than a decade.

In recent years, studies have suggested that the drugs can cause pancreatic problems, such as acute pancreatitis, a sudden swelling and inflammation of the pancreas that can cause serious abdominal pain felt mainly in the upper left side or middle of the abdomen. They may also cause abnormal cell growth in the pancreas, which is a risk factor for pancreatic cancer, one of the world’s most deadly cancers.

In July, the EMA announced that its review had found no new evidence of pancreas problems with these drugs, which they suggest may give patients some “reassurance.” However, both the EMA and the FDA said they will continue to investigate this “safety signal” and will report their findings and any recommendations at that time.

Source: PharmPro