The U.S. Food and Drug Administration (FDA) is investigating a possible link between a number of commonly used diabetes drugs and pre-cancerous changes to the pancreas, the agency announced.
The probe has been launched following a report by a group of researchers that suggests that the class of drugs known as incretin mimetics could lead to changes to the pancreas and its functions, resulting in a pre-cancerous condition. The group of drugs includes Merck & Co's Januvia, Victoza from Danish manufacturer Novo Nordisk and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc — some of the most commonly used drugs for treatment of type 2 diabetes.
According to the FDA website, this is not the first time that concerns of potential health risks have been raised regarding incretin mimetics but it warned that patients should continue to take their medicines as prescribed until further details have been announced. The aim of releasing this information at such an early stage was only to inform the public and healthcare professionals that an investigation has been started. The FDA will present its final conclusions and recommendations when additional information is available or when the probe has been completed.
The suggestion that incretin mimetics might lead to increased risk of pancreatic problems came from research by John Hopkins University, published in JAMA Internal Medicine journal. Researchers found that the drugs were associated with increased risk of hospitalization for acute pancreatitis, as agents in some of these drugs cause the formation of lesions in the pancreas. The FDA has already issued a public warning about cases of acute pancreatitis, which also includes fatal cases among patients on this type of medicines. According to the agency, package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.
This class of medicines, as its name suggests, mimics a natural hormone called incretin. The drugs prompt the pancreas to release insulin when blood sugar is increasing and are prescribed to treat type 2 diabetes. The vast majority of diabetes cases worldwide are type 2 diabetes, which is closely linked to obesity and sedentary lifestyle.
According to Reuters, sales of Merck's Januvia and its related drug, Janumet, are the company's biggest product franchiser, with combined sales reaching almost $6 billion last year. By comparison, Onglyza and a related drug called Kombiglyze had sales of $709 million in 2012.
Judson Clark, analyst at financial advisor Edward Jones, commented that the company would "keep an eye" on the development of the issue but it was still too early to say what the potential effect of the investigation on prescribing habits would be. However, he believed that the investigation would not affect sales dramatically because the increased pancreatitis risk was already noted on the drug labels.