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The diabetes drug Rezulin was withdrawn in 2000 due to associations with liver failure, and the FDA sharply restricted sales of another drug, Avandia, in 2010 after data linked it to heart-attack and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.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.
One Comment
rebekah smith
I am so frustrated. My husband, a 44yo health male, although about a year ago he was alittle overweight. He was diagnosed with diabetes and given januvia. He had a cat scan in the past year because he had kidney stone issues. In Jan 2013, he began having a pain in his front abdomine area that went around to his back, his primary dr had a cat scan done immediately (feb 19, 2013). They saw a tumor in the tail of his pancreasis and in his liver.On March 8,2013 he was given a diagnosis of stage 4 adv pan-can, liver, & lymph node cancer and the cancer cells were already in his blood. In the early morning hour(1:42am), he passed away from a massive pulmanary embolism. The drs never warned us to watch for blood clots. He had a pain in his left calf for 3 days prior to his passing. I understand that his life expectancity wasn't great, but only 56 days since finding first tumor. This was an aggressive form of pancreatis cancer. His dr and the family are going to go to the ends of the earth to have Januvia know what they have done is wrong. We have 3 bio children ages 20, 18, & 16yo and a foster child who is 18yo. He was an active hard working man, district manager for verizon wireless, working 60+ hours per week with no issues, his last day at work was only 2 days before his passing. I am disabled and unable to work, so januvia has now ruined a family and we will try our best that no other family will have to endure what we now have to. His doctor & my husband should have been warned about the chances of getting pancreatic cancer from januvia. How can a company get away with with holding this information?!? justice is needed. thank you for reading my story.
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