In 2010, the U.S. Food and Drug Administration approved Victoza, a diabetes drug made by Novo Nordisk for Type 2 patients to help control their blood-sugar levels. The medication soon became a success, generating about $670 million in sales the following year. Then, last year the FDA ordered Novo Nordisk to inform patients and health care professionals that Victoza carries the risk of causing thyroid cancer and pancreatitis in patients who use the medication.
Among the legal questions to be answered in Victoza lawsuits is whether the drug’s manufacturer conducted enough research about the health dangers that the drug might pose. The non-profit national consumer rights organization Public Citizen, which represents more than 250,000 members and supporters, thinks not. It petitioned the FDA to remove Victoza (liraglultide) from the market because some people enrolled in clinical trials to test the drug before it was approved by the FDA developed thyroid cancer or pancreatitis.
In its demand to the FDA for a ban on the medication, Public Citizen’s officials said:
“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. Read more about the Victoza lawsuit
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 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.”
Critics of the drug say these are alarming statistics for such a short period of time from when Victoza was approved and put on pharmacy shelves. At the present time Victoza lawyers are in the preliminary stage of meeting with victims and beginning their investigation of the safety of the medication. As fact and evidence-gathering intensifies they will be provided access to information about the side effects caused by Victoza and whether the manufacturer conducted sufficient testing.