Byetta Januvia Victoza Safety Review of Diabetes Drugs

They say where there is fire, there is smoke. According to some medical experts, there serious concerns regarding the use of the newer diabetic drugs and the increased risk of pancreatic cancer. As a Texas medical doctor and product liability attorney I have reviewed some of the initial data, and in my opinion there is an alarming signal that warrants further investigation.

There is a 2 day conference currently taking place at the National Institutes of Health where manufacturers, researchers and the FDA are gathered under one roof to pore over preliminary data. The giant pharmaceutical manufacturers, including Merck and Novo Nordisk said that they would cooperate with an independent review to address concerns of a potential link between widely used diabetes medicines and pancreatic cancer.

American Diabetes Association Raises Concerns

The American Diabetes Association (ADA) this week called for a new evaluation of clinical data on drugs used to control blood sugar for patients with type 2 diabetes. They include Merck & Co's $4 billion a year Januvia, Novo Nordisk's Victoza, and Byetta and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc, among others.

Incretin Mimetic Drugs Implicated

The new drugs under review are called incretin mimetics because they mimic hormones the body produces to stimulate release of insulin. They can be further classified as GLP-1 receptor agonists and DPP-4 inhibitors. GLP-1 drugs boost insulin production by the pancreas and slow absorption of food. DPP-4 inhibitors block an enzyme the breaks down the GLP-1 peptide in the gut, and increases insulin production. Bottom line these drugs increase insulin production in an already failing pancreas gland, the long term effects are now being called into question.

FDA Investigates

The U.S. Food and Drug Administration in March said it was studying unconfirmed reports that the drugs cause inflammation of the pancreas and pre-cancerous changes to cells in the pancreas. European health regulators are also studying the issue.

UCLA Medical Study

Earlier this year, new concerns arose from a small study conducted by a leading diabetes expert, Dr. Peter Butler, from the University of California, Los Angeles. Butler examined human pancreases from patients who had died of causes unrelated to pancreatic disease and found more pancreas lesions and one cancerous tumor in those who had taken Januvia or Byetta compared with nondiabetics or diabetics who had not taken those medicines.

New Medical Studies Underway

Bristol-Myers and AstraZeneca expressed support for the ADA initiative. Merck said it is committed to participating in the ADA effort, and is separately conducting a 14,000-patient heart safety study of Januvia.

According to Danish drugmaker Novo Nordisk, its studies to assess safety signals of its $1.8 billion a year Victoza do not reveal any evidence of increased risk of pancreatitis or pancreatic cancer.

The safety concerns are being discussed on Wednesday and Thursday at a workshop conducted by the National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).