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Concerns About Byetta, Januvia and Victoza Drug Safety

The National Institutes of Health held a workshop, addressing the risks associated with the newer diabetic drugs. These medications, known as Incretic Mimetics are coming under fire for alleged increased risk of pancreatic cancer.

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Merck & Co., Novo Nordisk A/S and others, the manufacturers of these drugs may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.

The Food and Drug Administration said it is considering setting up a study, either through the agency or the companies, that looks deeper into whether medicines for Type 2 diabetes, including Merck’s Januvia and Bristol Myers-Squibb Co.’s Byetta, cause pancreatic cell growth that could turn cancerous.

According to the FDA, a recent study demonstrated pre-cancerous cellular changes in diabetics taking incretin mimetics drugs. The FDA is reviewing the data and scientists from the agency and the companies are gathering today at the National Institutes of Health to further the investigation.

What are Incretic Mimetics?

Incretin mimetics help regulate blood sugar by stimulating insulin production by the pancreas and their prescribing labels carry warnings about the risk of inflammation of the organ. Merck’s Januvia had $4.1 billion in revenue last year, while Novo’s Victoza generated $1.6 billion and New York-based Bristol-Myers’s Byetta $149 million, according to data compiled by Bloomberg.

Pancreatitis Reports from 2007

Doctors have been concerned that these drugs may damage the pancreas since the FDA said in 2007 it received a high number of reports of pancreatitis in those taking Byetta. The agency issued a similar alert for Januvia in 2009. An analysis of insurance records published in February in the journal JAMA Internal Medicine showed such drugs may double a user’s risk of pancreatitis.

Manufacturers DownPlay the Risks

Merck, the second-largest U.S. drugmaker, said it will present an updated safety analysis for Januvia, its top-selling product, using data from 25 trials.

Novo is in the middle of a five-year epidemiological study using a large health-care claims database to look for incidence of thyroid cancer as well as pancreatitis and cancerous tumors.

Merck, Novo and Bristol-Myers also are conducting post-market studies on the heart safety of the diabetes drugs. Bristol-Myers said it and AstraZeneca Plc (AZN) have two such trials that will provide additional data on the pancreatic risks as well. Data from the first of those trials is expected later in 2013, Bristol-Myers said in an e-mail.

Connection Between Pancreatitis and Pancreatic Cancer

It is known that diabetes and pancreatitis are associated with pancreatic cancer, said David Whitcomb, co-chairman of the NIH meeting and chief of the division of gastroenterology, hepatology and nutrition at the University of Pittsburgh.

A study published in March in Diabetes, the journal of the American Diabetes Association, on diabetics’ pancreases showed a 40 percent increase in cell changes that could lead to cancer for those taking incretin mimetics.

Byetta Pancreatic Cancer Lawsuits

There are a growing number of Byetta cases filed by patients who have been diagnosed with pancreatic cancer after using the diabetes drug. The FDA has launched an investigation into the risk of pancreatic cancer with all incretin mimetic diabetes drugs. In addition to Byetta, Victoza and Bydureon, other drugs highlighted include Januvia (sitagliptin), Janumet (sitagliptin and metformin), Onglyza (saxagliptin) and Tradjenta (linagliptin).

The safety review was initiated after results of a recent medical study identified pre-cancerous cellular changes in pancreatic tissue taken from individuals treated with one of the drugs. European regulatory officials have also initiated a similar review.

Multi District Consolidation Requested

In April, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate all pancreatic cancer lawsuits filed by Byetta, Victoza, Januvia and Janumet patients, requesting that the cases be centralized before one judge in the federal court system for coordinated pretrial proceedings.