Why Hasn’t There Been an FDA Recall on Diabetes Drugs?
Written by Steve Fields on October 10, 2013
Why haven’t diabetes drugs such as Januvia, Byetta and Victoza been recalled?
After the publication of recent research, a growing number of individuals are calling for diabetes drugs known as incretin mimetics to be withdrawn from the market. They claim these drugs presents too high a risk to public safety to warrant their widespread availability. The main concern is a potential relationship between Januvia and pancreatic cancer. Many fear that using medication significantly increases the risk of developing the disease.
When cancer patients and their families learn that there may be a connection between diabetes medications and pancreatic cancer, they may be surprised that these medications are still on the market. In fact, a growing number of individuals who are filing lawsuits against the makers of certain diabetes drugs feel the drugs should be banned. The danger, they argue, outweighs any benefit diabetics might otherwise experience. Despite this, however, the Food and Drug Administration has not issued a recall for these diabetes drugs.
No Diabetes Drug Recall Announced Despite Serious Side Effects
Contrary to popular belief, most recalls are actually issued by drug manufacturers, not the FDA. Manufacturer recalls occur when a drug company determines, either through research or adverse event reports, that its product does not meet safety standards. This could be because of a mistake in production or packaging, an allergen that is not declared on the drug’s label, or unexpected side effects.
At this time, it appears unlikely that the manufacturers of diabetes drugs will recall them over concerns of pancreatic cancer. Merck, the maker of Januvia, issued a press release in March 2013 emphasizing that Januvia was safe.1 “Based on review,” Merck said, “we find no compelling evidence establishing a causal relationship between the use of sitagliptin and pancreatic cancer.” Novo Nordisk made a similar defense of its incretin mimetic, Victoza, in a letter to the British Medical Journal.2
In the absence of a voluntary manufacturer’s recall, the FDA will occasionally issue a recall of its own. This is a relatively rare occurrence, and to this point the agency has resisted issuing a recall for diabetes drugs. Instead, the agency has simply stated that it “is continuing to evaluate all available data to further understand this potential safety issue.”3
Public Citizen Calls for FDA Recall of Victoza
There is, however, growing public outcry in favor of a recall for diabetes drugs. In April 2012, Public Citizen, a consumer advocacy group, asked the FDA to recall the incretin mimetic Victoza (liraglutide).4 The organization noted that use of the drug increases the risk of thyroid cancer, kidney failure, and pancreatitis. The following year, the director of Public Citizen’s Health Research Group issued a statement that included the following:
“Although we have previously petitioned the FDA to ban Victoza (liraglutide) because of concerns about pancreatic disease and thyroid cancer, it is clear that all of the drugs in this family are associated with an increased risk of pancreatic cancer and it is likely that they will all have to be removed from the market.”5
To date, the FDA has issued no recall for Victoza, Byetta, Januvia, or any other incretin mimetic.
If you have been diagnosed with pancreatic cancer after using an incretin mimetic diabetes drug, you may be entitled to financial compensation for your injuries. Contact a diabetes drug lawyer to discuss your case. The consultation is free and confidential. Our attorneys are here to listen as you describe your experience with diabetes drugs, and offer advice regarding your legal options.