Public Citizen Out Early on Warnings Regarding Januvia

Washington, DCIt was more than a year ago that the US Food and Drug Administration (FDA) urged a change to the product labeling for Januvia, an oral Type 2 diabetes drug, with regard to various Januvia side effects. However, critics say that the FDA was slow off the mark, given that reports of adverse reactions were coming in soon after Januvia was approved.

Public Citizen was off the mark sooner. The consumer advocacy group had posted Januvia to its Worstpills.org Web site in June of 2007, advising then that Januvia should not be used until seven years after its introduction on the market??"no earlier than 2014??"due to a lack of insight and data regarding its safety and efficacy long-term.

said Dr. Sidney Wolfe, director of the health research group at Public Citizen, in comments released June 1 of 2007. "They should not be human guinea pigs and risk being harmed by the adverse effects associated with Januvia that may be magnified with time, as they were with Avandia."

The Januvia diabetes drug was approved by the FDA in October 2006. Almost immediately the adverse reactions began pouring in, with the FDA beginning to receive reports of Januvia pancreatitis starting October 16??"the very month the drug was approved. Of 88 reports of pancreatitis reported between October 16, 2006 and February 9, 2009, 19 patients suffered the onset of pancreatitis within 30 days of starting the drug.

Little wonder that the reports started rolling in almost immediately after Januvia (sitagliptin) was approved.

In railing against Januvia, Public Citizen noted that even in clinical studies, trial participants were found to experience an increased level of creatinine, which is found in the blood and is often an early indicator of kidney problems.

The FDA's own medical officer whose jurisdiction included Januvia concluded, following a review, that Januvia's performance was at best, "fairly modest."

Public Citizen has an enviable track record of raising concerns about potentially problematic drugs and remains well ahead of the curve. The June 2007 statement noted that the advocacy group's warning about Type 2 diabetes drug Avandia was two years ahead of the release of the Dr. Steven Nissen study in the New England Journal of Medicine.

With Januvia adverse reactions, including concern for Januvia cancer, Public Citizen notes that many of the newer drugs designed to treat Type 2 diabetes "are often no more potent or effective than the older diabetes drug families: insulin, the sulfonylureas and the biguanides. Because Januvia is not a 'breakthrough' drug??"one that is significantly more effective than drugs already on the market??"Wolfe advises patients with type 2 diabetes to wait to see if it is truly as safe as its manufacturer, Merck, claims," states the press release.

In the meantime, anyone considering a Januvia lawsuit may well consider the lag time between October 16, 2006??"when the first adverse reaction reports were received by the FDA??"and September 25, 2009, when the agency issued a revision to the warning label. The lag time, nearly three years, could have caused dozens (if not hundreds) of people to suffer needlessly.