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FDA investigates pancreas risk of diabetes drugs

Products from Merck & Co, BMS, AZ, Novo Nordisk, Boehringer, Amylin and Takeda all involved

FDA investigates pancreas risk of diabetes drugs

The US FDA has launched an investigation into a certain group of diabetes drugs after they were linked to changes in the pancreas that could lead to pancreatic cancer.

The affected products are all incretin mimetics, which work by simulating the body's natural incretin hormones that stimulate the release of insulin in response to a meal.

They include established big-selling products, such as the GLP-1 agonists Byetta/Bydureon (exenatide) from Amylin and Victoza (liraglutide) from Novo Nordisk, as well as the DPP-4 inhibitors Januvia (sitagliptin) from Merck & Co and Onglyza (saxagliptin) from Bristol-Myers Squibb/Astrazeneca.

Newer DPP-4 inhibitors Tradjenta (linagliptin) from Boehringer Ingelheim and Takeda's alogliptin-based medicines (Nesina, Kazano and Oseni) are also affected.

The FDA's investigation follows a study published by academic researchers that examined a small number of pancreatic tissue specimens taken from patients taking incretin mimetics after they died from unspecified causes.

Findings from this study suggested a possible increased risk of pancreatitis, according to the FDA, while pre-cancerous cellular changes were also detected.

Although the FDA said it has “not reached any new conclusions about safety risk” of these drugs, the agency has requested that the researchers behind the initial study provide both the tissue specimens and the methodology used to test them to allow it to carry out its own investigation into the potential pancreatic toxicity of incretin mimetics.

Concerns about the effect of incretin mimetics have previously been known to the FDA, with both Byetta/Bydureon and Januvia carrying labels that warn about the risk of acute pancreatitis.

However, the agency has been on a heightened alert about the safety of diabetes drugs since GSK's Avandia was found to increase the risk of cardiovascular events.

The drug was withdrawn in the EU and had its use limited in the US in 2011, while GSK has had to pay out billions of dollars in related fines.

Some commentators have suggested public outcry over Avandia has led to a tougher stance from the FDA regarding the safety of diabetes medicines, leading to its refusal to recommend Novo's new diabetes products Tresiba and Ryzodeg despite their approval in Europe and Japan.

Nevertheless, the FDA has advised patients who have been prescribed incretin mimetics to continue taking their medicine, while healthcare professionals should continue to follow prescribing recommendations as usual while the investigation is carried out.

18th March 2013

From: Sales, Regulatory, Healthcare

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