The U.S. Food and Drug Administration (FDA) urged a change to the product labeling for Januvia, an oral Type 2 diabetes drug, over a year ago regarding various Januvia side effects. Many are arguing that the FDA was slow to urge this change regarding the drug side effects, given reports of adverse reactions that had been coming in since Januvia had been approved. On the other hand, Public Citizen had posted Januvia to its Worstpills.org website in June 2007, advising that Januvia should not be used until seven years after its introduction on the market – no earlier than 2014.
In October 2006, Januvia was approved by the FDA and the adverse reactions began rolling in shortly thereafter with the FDA receiving reports of pancreatitis with Januvia starting the very month that the drug was approved. Of 88 reports of pancreatitis reported from October 2006 to February 2009, 19 patients suffered the onset of pancreatitis within a mere 30 days of starting the Januvia drug. Public Citizen noted that even in clinical studies, trial participants were found to experience an increased level of creatinine in their bodies, which is often an early indicator of kidney problems. Anyone considering a Januvia product liability lawsuit may consider the lag time between October 2006 – when the first negative side effect reports were received by the FDA – and September 2009 – when the agency revised the drug’s warning label. This time should have spent to prevent further suffering by those who take Januvia.
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Visit Public Citizen for more information on their early warning against Januvia.