Eli Lilly and Company (LLY) and Boehringer Ingelheim Pharmaceuticals, Inc. recently announced that the labels for their diabetes drugs, Tradjenta (linagliptin) and Jentadueto (linagliptin plus metformin) will be updated in the US. Eli Lilly and Boehringer Ingelheim said that the label updates had been approved by the US Food and Drug Administration (:FDA).
The label updates will provide information needed to ensure the proper use of these medicines by physicians, pharmacists and patients.
Eli Lilly and Boehringer Ingelheim said that the Prescribing Information (:PI) section of the labels for Tradjenta and Jentadueto will carry additional information regarding the risk of pancreatitis. The Important Limitations of Use sections within the Indications and Usage sections will be updated with the information that both drugs have not been studied in patients with a history of pancreatitis.
Moreover, this section will state that it is not known whether patients with a history of pancreatitis will be at a higher risk for the development of pancreatitis while using Tradjenta or Jentadueto.
Meanwhile, the Warnings and Precautions section will include information regarding post marketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin.
The Patient Counseling Information section will also include information about the potential risk and symptoms of pancreatitis. This section of the label carries instructions asking healthcare providers to inform their patients about the potential risks and benefits associated with the use of Tradjenta or Jentadueto.
Eli Lilly and Boehringer Ingelheim also said that they will inform physicians prescribing dipeptidyl peptidase 4 (DPP-4) inhibitors and pharmacists about the label update.
The risk of pancreatitis associated with the use of certain types of diabetes drugs has been a matter of concern. Earlier this year, the FDA had announced that it is evaluating unpublished new findings by academic researchers which indicate that there could be an increased risk of pancreatitis and pre-cancerous cellular changes (pancreatic duct metaplasia) in type II diabetes patients being treated with incretin mimetics.
Safety concerns surrounding the use of GLP-1 inhibitors have also been in the news. Key players in the diabetes market include Eli Lilly, Merck (MRK), Novo Nordisk (NVO) and Sanofi (SNY) among others.
Eli Lilly currently carries a Zacks Rank #3 (Hold). At present, Novo Nordisk looks well-positioned with a Zacks Rank #2 (Buy).
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