FDA Petitioned to Remove Diabetes Med Victoza (Liraglutide) from the Market

Washington, DCA petition to have the diabetes medication Victoza (liraglutide; Novo Nordisk) pulled from the market has been made by the consumer watchdog group Public Citizen. In their letter to the Food and Drug Agency (FDA) the organization states that Victoza should be pulled “because the known increased risks of thyroid cancer and pancreatitis, both of which occurred in people enrolled in preapproval clinical trials, outweigh any documented clinical benefits.”

The letter goes on to state “The FDA clinical safety reviewer concurred with the conclusions of the pharmacology team but added an additional concern: the unknown risk of major cardiovascular events, such as cardiovascular death, myocardial infarction, or stroke. Both cardiologists and the biostatistician on the advisory committee agreed, stating that, because of trial design deficiencies in assessing cardiovascular risk in preapproval trials, it was not possible to rule out unacceptable excess cardiovascular risk relative to comparator drugs.

Between January 2010, the month of liraglutide’s FDA approval, and June 2011, the FDA has, in fact, issued new warnings on pancreatitis, thyroid C-cell tumors, and worsening renal function, including acute renal failure associated with the use of liraglutide. Public Citizen’s analysis of the Adverse Event Reporting System (AERS) database (from February 2010 through September 2011) found 200 cases of acute pancreatitis and 28 cases of pancreatic cancer as well as 26 cases of thyroid tumors, reported to the FDA by people using liraglutide.”

Lawyers and Settlements reported on June 15, 2011, about the FDA warning regarding Victoza and a possible risk for thyroid cancer and pancreatitis.