More Trouble Ahead for Diabetes Drug Makers

The pressure on Merck, Bristol-Myers Squibb (BMS) and other manufacturers of incretin mimetic drugs used to treat type 2 diabetes appears to be increasing both from the FDA and plaintiff’s lawyers specializing in products liability and mass tort litigation.  Unpublished research results are behind a recent FDA Drug Safety Communication relating to incretin mimetic drugs and the FDA is collecting information on how this class of drugs might contribute to inflammation of the pancreas as well as pre-cancerous conditions (known as pancreatic duct metaplasia) in patients with type 2 diabetes.  After several years of tighter label warnings and published reports of pancreatitis and pancreatic cancer in patients taking Januvia (Merck), Byetta (Amylin/BMS) and Victoza (Novo Nordisc), the number of lawsuits and lawyers trolling for clients on the web are proliferating.

Type 2 diabetes, formerly known as adult-onset diabetes, is the most common form of the disease. Millions of Americans have been diagnosed with type 2 diabetes, which is frequently associated with obesity.  Many more people are at high risk of type 2 diabetes, but have not been officially diagnosed with the condition.  Most type 2 diabetes patients have been treated with one or more incretin mimetic drugs.

Incretin Mimetic Drugs

Drugs in the incretin mimetic class (and their manufacturers) include:

  • Exenatide (Byetta, Bydureon/injection) (Amylin, which was acquired by BMS, which co-markets with Astra-Zeneca)
  • Liraglutide (Victoza/ injection) (Novo Nordisc)
  • Sitagliptin (Januvia, Janumet, Janumet XR, Juvisync/tablets) (Merck)
  • Saxagliptin (Onglyza, Kombiglyze XR/tablets) (BMS/AZ)
  • Alogliptin (Nesina, Kazano, Oseni/tablets) (Takeda)
  • Linagliptin (Tradjenta, Jentadueto/tablets) (Boehringer Ingelheim)

The incretin mimetic drugs exenatide and sitagliptin prompted an earlier FDA public warning about the risk of acute pancreatitis, including fatal and serious nonfatal cases.  However, as Merck pointed out in a 2009 statement responding to the FDA’s requirement that the Januvia label disclose 88 reported cases of acute pancreatitis, “[p]atients with type 2 diabetes are more likely to develop pancreatitis than other people, and as the FDA noted in a publication earlier this year, ‘diagnosis [of drug-induced pancreatitis] poses a challenge since it can be difficult to rule out other causes’.”  Fair enough.  But while actual causation maybe difficult to prove, the temporal association between the use of incretin mimetic drugs and pancreatitis and even pancreatic cancer (which often follows pancreatitis) is troubling.  In fact, according to the FDA, a recently published study that examined insurance records also found that the use of exenatide or sitagliptin could double the risk of developing acute pancreatitis.  In that administrative database study, academic researchers had a stated goal “to test whether GLP-1–based therapies such as exenatide and sitagliptin are associated with an increased risk of acute pancreatitis.” Those findings were published in a JAMA Internal Medicine article on February 25, 2013.

The potential for pre-cancerous pancreatic conditions is a new risk factor not previously mentioned by the FDA. The agency cautions, however, that their evaluation of incretin mimetics in regard to pancreatic side effects is in the early stages. The FDA has not yet concluded that these drugs may cause or contribute to the development of pancreatic cancer, but for drug manufacturers, the danger signs are there.  While it is still too early to tell where the FDA will go with all of this, if the agency ultimately concludes that the risks of some or all incretin mimetic drugs outweighs the benefits to diabetic patients, a company like Merck (which earned more than $5 billion in revenues from Januvia and Janumet in 2011) could end up facing a Vioxx-like avalanche of lawsuits, which would make the lawyers on both sides of the mass tort litigation the only winners.


About Jose Sierra

José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Prior to joining the firm, Mr. Sierra was Senior Vice President, Chief Compliance and Ethics Officer for Sepracor Inc., a specialty pharmaceutical company. Earlier in his career he held positions as Vice President, Chief Compliance and Ethics Officer for Kos Pharmaceuticals, Inc., Legal Director at Schering-Plough Corporation, and Assistant U.S. Attorney in the U.S. Attorney’s Office in Newark, New Jersey.

Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on litigation, government investigations, qui tam/whistleblower defense, compliance, and risk management. Contact him at 617-956-5926 or via .

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