FDA Investigates Safety Of Type 2 Diabetes Drugs Januvia And Byetta

Editor's Choice
Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Mar 2013 - 0:00 PDT


The U.S. Food and Drug Administration is investigating whether or not the Type 2 Diabetes drugs Januvia (from Merck) and Byetta (from Bristol-Myers Squibb) are associated with an increased risk of developing pancreatic cancer.

Close to 25 million people in the United States have diabetes, costing the country an estimated $245 billion a year. There's been a huge rise in the number of treatment options over the last few years. Many patients have to take more than one drug to stabilize their blood sugar levels and insulin.

However, the safety of all these new diabetes medications is still under thorough investigation, the FDA informa.

Data from a report in JAMA's Internal Medicine indicated that patients who took the diabetes drugs Januvia and Byetta were at a much risk of developing pancreatitis compared to those who weren't.

Januvia is an oral antihyperglycemic, it is either used alone or in combination with other other oral antihyperglycemic agents, such as metmorfin. Byetta is a glucagon-like peptide-1 agonist administered twice a day as a subcutaneous injection.

The FDA is looking at all the medications belonging to a class of drugs called incretin mimetics (which includes Victoza and others), which stimulate the production of insulin.

Following the results of a study carried out last month that analyzed insurance records, Merck and Bristol were quick to state the safety of their drugs. Merck even said they found "no compelling evidence of a casual relationship" between Januvia and pancreatitis or pancreatic cancer.

In 2007, the FDA added information to the labels of Byetta about its association with pancreatitis and in 2009 the agency did the same with Januvia and Janumet.

The FDA said:

"The FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer. At this time, patients should continue to take their medicine as directed until they talk to their health care professional."

Some analysts believe that the investigation won't have much of an impact on the sales of the drug, given that past investigations haven't resulted in drastic changes. They believe that the most the FDA will do is add more warnings about the increased risk of pancreatitis and pancreatic cancer.

Merck would be impacted the most by the findings; last year the drug Januvia generated sales of more than $4 billion and it's sister drug Janumet generated a further $1.65 billion for the company.

The drug Byetta only generated sales of $310 million last year for the three companies that share the drug; BMS, AstraZeneca and Eli Lilly.

The FDA concluded:

"At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels."

Written by Joseph Nordqvist


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