Monday, 3 September 2012
Victoza Next diabetes drug to be banned ?
Public Citizen, representing more than 250,000 members and supporters nationwide, hereby
petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug, and
Cosmetic Act (FDCA) 21 U.S.C. § 355(e) and 21 C.F.R. 10.30, to immediately remove from the
market the diabetes drug liraglutide (Victoza; Novo Nordisk) 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 FDA pharmacology reviewers concluded, prior to liraglutide’s approval, that it was not
approvable due to its induction of thyroid C-cell tumors in animals at drug exposures similar to
drug exposures seen in people taking the drug.
No information concerning the mechanism for this tumor-inducing effect of the drug in animals
could rule out a similar risk to humans. The Endocrinologic and Metabolic Drugs Advisory
Committee (EMDAC) agreed that it could not rule out the thyroid as a possible target organ for
neoplasm induction in people. To the question, “Has the applicant provided adequate data on the
animal thyroid C-cell tumor findings to demonstrate that these findings are not relevant to
humans?” 12 committee members voted “no,” including both thyroid cancer experts; there was
only one “yes” vote.
There was the additional problem of how to monitor patients for
preneoplastic effects as well as thyroid tumors.
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 Febuary 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.