New Delhi: Diabetes drug Januvia, marketed in India by an affiliate of US-based drug maker Merck and Co. Inc., has been linked by the US Food and Drugs Administration (FDA) to inflammation of the pancreas, a condition known as pancreatitis.
The drug is sold in India by Merck Sharp and Dohme Pharmaceuticals Pvt. Ltd (MSD) at one-fifth the price in the US. The company says it is confident that Januvia, which has the generic name sitagliptin, is safe despite a notification issued by the FDA last week.
Safe or not? The Merck headquarters at New Jersey in the US. Merck’s affiliate that sells Januvia in India says it is confident the drug is safe despite a notification on its risks issued by the FDA last week. Emile Wamsteker / Bloomberg
Januvia was launched in India early last year and garnered sales worth $1.5 million (Rs7.2 crore) until December. Its global sales in 2008 stood at $1.34 billion, up from $617 million in 2007, according to ORG IMS Research Pvt. Ltd, a pharmaceutical research firm.
The US drug regulator notified healthcare professionals and patients of revisions to its prescribing information for Januvia after 88 cases of acute pancreatitis were reported in the post-marketing surveillance between October 2006 and February 2009.
“Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis,” the FDA said in a statement.
Out of 194 million diabetics in the world, 31 million are in India, according to the World Health Organization.
Drug controller general of India Surinder Singh said on Thursday that he had been out of town and wasn’t aware of the FDA notification, but would look into it.
Januvia is used to improve glycemic control in adults with type 2 diabetes, or adult onset diabetes. Acute pancreatitis occurs suddenly and is usually resolved while chronic pancreatitis results in slow destruction of the pancreas, according to MedicineNet.com, an online provider of medical information for consumers. In severe cases bleeding, tissue damage and infection may occur. Enzymes and toxins may enter the bloodstream, injuring the heart, lungs and kidneys or other organs, it said.
MSD said in the nearly three years of marketed use, at least 16 million prescriptions have been dispensed for sitagliptin (Januvia) worldwide.
“Till date sitagliptin has not found to be associated with an increase in the incidence of pancreatitis in either preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients,” said Swashraya Shah, medical director at the Merck affiliate. Shah added that its safety and efficacy was established in Indian patients through a registration study, following which the drug was permitted to be sold in India. “As per Indian regulations, global periodic safety update report that captures all reported adverse events...needs to be submitted to the regulatory authority, every six months and Merck/MSD has been compliant to this requirement.”
Endocrinologists are not surprised with FDA’s concern, although they added that Januvia’s benefits outweighed its risks and there have been no adverse reports from the drug’s use in India, which, however, does not have a robust adverse drug reporting system in place.
“It is not a surprising report since drugs in this class have been known to cause pancreatitis,” said Anoop Misra, director and head, department of diabetes and metabolic diseases, at Fortis Hospitals.
“However, this class of drugs are a breakthrough in the treatment of diabetes, and in our sizeable experience, they work well on blood sugar and pancreatitis has not occurred with their use,” Misra said. “Overall, a clinician should be aware of this potential adverse effect and monitor patient accordingly.”
Because such drugs act through the pancreas, there is always a theoretical possibility of them having an effect on the pancreas, says Ambrish Mittal, senior consultant endocrinologist at Apollo Hospital, New Delhi.
“But none of the studies on Januvia have shown any such risk,” Mittal said. “Remember that diabetics are prone to pancreatitis and at present the data on Januvia doesn’t warrant any change in practice. But we are planning to report all adverse cases that we see and be more alert.”