As a Texas medical doctor and Dallas Januvia Pancreatic attorney I am providing this timely information regarding the potential dangerous risks assciated with the newer diabetic medications on the market. As mentioned before, this increase for pancreatitis and pancreatic cancer appears to be a class effect involving the so called Incretin Mimetics.
FDA Investigations
Recently our FDA regulators got in on the act and opened a review of drugs from Merck, Bristol-Myers Squibb Co. and other pharmaceutical makers.
The Food and Drug Administration said it was asking researchers for more information about how the drugs, used to treat type-2 diabetes, could lead to inflammation of the pancreas and cause precancerous changes in cells.
Federal regulators are investigating a multibillion-dollar class of diabetes drugs after recent reports that they could be linked to pancreatic cancer.
Medical Studies Demonstrate Increased Risk of Pancreatitis and Pancreatic Cancer
Medical journal articles and case reports over the past several years have indicated potential problems with Bristol-Myers's Byetta and Bydureon, Merck's Januvia and other related drugs.
Why is Diabetes and Drug Side Effects Important?
Type 2 diabetes is the scourge of post industrialized society and more so in the US, where it is estimated that a third of our adult population is frankly obese and one third are over weight, these are significant risk factors for the development of adult onset diabetes. According to experts, diabetes affects about 26 million Americans.
The diabetes drug Rezulin was withdrawn in 2000 due to associations with liver failure, and the FDA sharply restricted sales of another drug, Avandia, in 2010 after data linked it to heart-attack and stroke risk.
Byetta, Bydureon and Novo Nordisk A/S's Victoza are injected drugs that work on a hormone called GLP-1. Januvia is a pill that works indirectly on GLP-1.
In a commentary published Feb. 27 in the British journal BMJ, Edwin A.M. Gale, former professor of diabetic medicine at Southmead Hospital in Bristol, England, wrote that the number of pancreatitis case reports to the FDA had reached "astronomical dimensions." "Should we be worried about this?" he asked. "Very much so." He added that "all forms of pancreatitis, clinical or subclinical, predispose to carcinoma of the pancreas."
Manufacturers Say Their Drugs Are Safe
Bristol-Myers said Byetta "has been associated with acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis." But the company said it was "confident in the positive benefit-risk profile" of Byetta and Bydureon, an extended-release version of the same medicine.
Merck said it was "confident in the safety profile" of Januvia and has "seen no compelling evidence of a causal relationship" between the drug and pancreatic complications.
An editorial in February 2010 in the journal Diabetes Care by Peter Butler, an endocrinologist at UCLA, questioned the emerging prominence of this new class of drugs. There is a "plausible risk" that patients may develop pancreatitis, he wrote, "and worse, subsequently a minority of individuals treated by this class of drugs may develop pancreatic cancer."
In 2011, Dr. Butler and colleagues from UCLA wrote in Gastroenterology about an analysis of the FDA's database of adverse events. "Use of sitagliptin [Januvia] or exenatide [Byetta and Bydureon] increased the odds ratio for reported pancreatitis 6-fold" compared with other drugs, they wrote.
The safety issues intensified with Novo Nordisk's Victoza, which the FDA approved despite evidence of pancreatitis in clinical trials and cancer in lab animals. The agency approved the drug, concluding that the benefits outweighed the risk.
