Drug maker, Merck, may be facing fines over how it conducted diabetes drug studies for Januvia and Janumet.
Merck may be fined by U.S. regulators for neglecting to test if Januvia and Janumet may raise risks for inflamed pancreas, said Reuters, citing a U.S. Food and Drug Administration (FDA) warning letter posted online yesterday.
Merck said it would conduct a post-approval study of the drugs in mice to determine if the drugs increase risks for acute pancreatitis, according to the agency’s warning letter, dated February 17. If not treated, pancreatitis is deadly, said Reuters.
The agency can mandate companies to conduct additional drug trials following approval to resolve safety issues. Failure to comply with the FDA’s request can lead to fines of up to $250,000. “Your product is considered misbranded because you are in violation of a post-marketing requirement,” wrote Leslie Ball, acting director of the FDA’s office of scientific investigations, in the letter to Merck, said Reuters. “You have failed to comply with the approved timetable … and failed to show good cause for not conducting the additional testing required,” Ball added.
Januvia and Janumet work to lower blood sugar levels in patients with Type 2 diabetes. Approved in 2006, Januvia was soon linked to reports of patients suffering from inflamed pancreas, said Reuters. The FDA asked Merck to study the link to determine if the drug was causing the problem. Janumet is a combination of sitagliptin and metformin, and is a an older medication that helps to control blood sugar levels, said Reuters.
Although Merck argued that people with diabetes are likelier to develop pancreatitis, it did agree to conduct a three-month test, said the FDA, but only after it was supposed to have submitted a report on the matter last year. Its study design was to be to the agency by June 15, 2010 and its final report by June 15, 2011, Reuters noted. The drug maker never submitted a study design, saying it would rely on an independent study to review safety, although the FDA did not agree to this plan, the agency said.
Merck promised, on its web site, to submit its final study design to the FDA within 30 days of the day it received the FDA letter, adding that it would begin the study within six months, wrote Reuters.
We previously wrote about an prior study that indicated that some doctors were becoming wary of Januvia, after research linked the drug to an increased risk of pancreatitis and pancreatic cancer. Prior to that, a study published in the journal Gastroenterology found that Januvia was associated with a 6-fold increased risk of pancreatitis as compared with other therapies. The same study also found that the event rate for pancreatic cancer was 2.7-fold greater among patients taking Januvia. The Gastroenterology study was based on an analysis of reports made to the FDA’s Adverse Event Reporting Database between 2004 and 2009.
In September 2009, the FDA warned doctors to monitor patients carefully for signs of pancreatitis among people taking Januvia and Janumet after 88 cases of the disease were reported in patients taking those drugs. Fifty-eight of those patients required hospitalization, and four required treatment in intensive care units, the agency said.