US medicines watchdog, Food & Drug Administration (FDA), has issued words of caution against usage of US pharma giant Merck & Co’s much hyped blockbuster diabetes drug Januvia.
The FDA has raised fears of link between the drug and risk of pancreatitis, which is inflammation of the pancreas characterised by severe abdominal pain.According to a FDA statement, 88 post marketing cases of acute pancreatitis in patients using Januvia (sitagliptin) were reported between October 2006 and February 2009.
The FDA is working with the manufacturer to revise prescribing information to include information regarding reports of acute pancreatitis, and recommending that physicians monitor patients for risks of pancreatitis. It says that labelling should point out that Januvia hasn’t been studied in patients with a history of pancreatitis.
The warnings also pertain to Janumet, which is sitagliptin along with another diabetes medication, metformin.Januvia, which is an oral medication for type II diabetics, is said to be a key drug for the company, which has been working to rebuild its pipeline since the 2006 patent expiration of blockbuster cholesterol drug Zocor, and 2004 market withdrawal of arthritis painkiller Vioxx on account of side effects such as heart attacks and strokes.
Januvia is said to be pumping in $1.4 billion per year, with nearly 16 million prescriptions dispensed globally since its launch in 2006.Industry experts say that although the FDA warnings may not hit sales of this product hard, they can make doctors stingy when prescribing the drug.
Swashraya Shah, medical director, MSD Pharmaceuticals, local affiliate of Merck &Co, said that Merck/MSD has been thoroughly monitoring the safety of sitagliptin, and till date the product has not found to be associated with an increase in the incidence of pancreatitis in either pre-clinical studies or in clinical trials of up to two years in duration done in over 6,000 patients.
“Type II diabetics are more prone to pancreatitis than other people. We believe that no causal relationship can be determined between sitagliptin and pancreatitis,” Shah told DNA.
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