Incretin Mimetics

Study Indicates Type-2 Diabetes Drugs Carry Extreme Risk of Pancreatic Complications

Studies of the effects of incretin mimetics are crucial to understanding how these drugs may be affecting consumers in adverse ways.

Consumers rely on this information to make educated decisions when choosing medications.

Researchers who were not wholeheartedly convinced by the supposed safety of incretin mimetics decided to look to the FDA adverse reporting system to see how these drugs affected humans.

In individuals who took incretin mimetics, the researchers found an increase in the number of reports of pancreatitis and pancreatic cancer.

Yet, it was not just researchers who noted the link. In September 2008, drug manufacturer Eli Lilly noticed a connection between Byetta and pancreatitis.

However, they maintained that the warning on the drug of contracting acute pancreatitis was sufficient and adequately communicated.

Furthermore, in 2009, the FDA asked Merck and other companies that manufactured these drugs to do further safety studies using rats which resulted in the death of three rats.

Frighteningly enough, the pharmaceutical companies continue to state that these drugs cause no damaging effects.

In an independent analysis of health insurance published in February 2013, researchers found that people taking GLP-1 incretin mimetics were at twice the risk of hospital admission for acute pancreatitis as compared with people taking other anti-diabetic drugs.

In 2013, an independent body released the results of its research indicating that the entire class of incretin mimetics may carry up to 20 times the risk of developing pancreatic cancer for patients taking these drugs.

The Institute for Safe Medication Practices “ISMP” analyzed data from the FDA Adverse Event Reports between July 1, 2011, and June 30, 2012, from 1,723 patients taking these drugs.

The ISMP concluded that the increased risk of developing pancreatic cancer for patients taking these drugs could be as much as 20% higher than those who were taking other medications to control their type-2 diabetes.

Tom Moore, a senior scientist for drug safety and policy at the ISMP said, “I think the whole class is in question.”

Moore further stated that additional analysis is required, but “if the results are confirmed in a broader patient population, it raises questions about the entire class of drugs.”

Although this data has some inherent limitations because it is based on adverse event reporting, it is a significant signal that more study and investigation should be undertaken, especially considering the other reports from different investigators found similar alarming connections between the drugs and pancreatic cancer.

The results of these studies are very unfavorable to the drug manufacturers who continue to maintain that their product is safe.

Unsurprisingly, this research has shown that these manufacturers continue to put profit above safety when they conduct inadequate testing and put unsafe drugs on the market.

In an effort to dismiss allegations that their product was unsafe, Merck offered to fund a professor at the University of California, Los Angeles to conduct a study about the effect of sitagliptin (Januvia) on rats that have diabetes similar to that in humans.

What should not have been a shock to Merck, the results of this study demonstrated that their product caused an increase in pancreatic damage.

During the 12-week study, the researchers gave the rats sitagliptin, metformin, or a combination of both drugs.

When examining the rats after the 12 weeks, the researchers found that every rat given sitagliptin had an enlarged pancreas.

Furthermore, one rat showed acute pancreatitis and 3 out of 16 had acinar to ductal metaplasia, a pathological change thought to be a potential precursor of pancreatic cancer.

Immediately after these results were published, Merck held a closed-door meeting to discuss the adverse findings.

In this meeting, a professor of digestive diseases said that the results of the study could suggest an increased risk of pancreatic cancer.

Had Merck and other pharmaceutical companies adequately tested these drugs before rushing them to the market, they likely would have found these results before the drug caused pancreatic damage to thousands of users.

FDA Approval System Growing Concern

As pharmaceutical drug liability cases continue to grow, many are left questioning the FDA’s approval method of these dangerous drugs. FDA approval is based on surrogate measures, such as tests that lower blood sugar levels but not on proof that they prevent heart attacks. Drugs can be approved so long as they are deemed safe in early studies based on the limited surrogate measures.

FDA’s Adverse Events Reporting System collects case reports from the public and medical community. Nevertheless, the majority of cases are unaccounted because the reporting system is voluntary for users and health professionals. Although drug companies are required to file reports, patients and doctors rarely report incidents to drug manufacturers. The system is deeply flawed as there are more reports that staff can review, thus it may be years after a drug was approved before the public is warned of any side effects.

According to an analysis of case reports from 2004 to March 2014, there were 964 deaths and 4425 hospitalizations amongst users of Januvia. The analysis also reported 880 deaths and 7115 hospitalizations amongst users of Byetta.

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are continuing to investigate the connection between this class of drugs and pancreatic cancer.

Why are Incretin Mimetics Still on the Market?

More concerning news surrounding popular Type-2 diabetes medications and their link to pancreatic cancer has come to light. Independent academic and scientific researchers have called on the FDA to take a serious look at their data concerning certain incretin mimetics and their potential to cause this serious and oftentimes fatal form of cancer.

At the urging of these researchers, the FDA is currently reviewing a recent body of research that suggests pre-cancerous cellular changes in the body may be triggered by incretin mimetic medications. These changes may produce an inflammation of the pancreas, which has been shown to cause pancreatic cancer.

In addition, reports of pancreatitis associated with the use of these drugs continue to flood through the doors of the FDA.

As of 2019, both classes of incretin mimetics are still being marketed to millions of people with Type-2 diabetes. But, there is a reason for the manufacturer’s insistence the drugs are safe for consumers. Merck’s global sales increased from $2.39 billion in 2010 to $3.7 billion in 2017. Additionally, the manufacturer has since released newer Type-2 diabetes medications, likely to be profit-driving drugs, too.

More and more research continues to emerge linking these Type-2 diabetes medications with pancreatic cancer, pancreatitis, and thyroid cancer. However, the profits of incretin mimetic drugs are substantial. Manufacturers are not going to give up these products without a fight.

Interested in an Incretin Mimetics Lawsuit? TorHoerman Law Can Help

Contact TorHoerman Law to review your legal options in an incretin mimetics lawsuit if you or a loved one have suffered side effects such as:

• Pancreatitis or pancreatic cancer that is believed to be caused by:
  • Byetta
  • Victoza
  • Byuderon
  • Onglyza
  • Kombiglyze XR
  • Januvia
  • Nesina
  • Tradjenta
  • Janumet