Victoza lawyers at Pintas & Mullins Law Firm highlight a recent Drug Safety Communication by the FDA alerting the public that Victoza and other type 2 diabetes medications are linked to increased risk of pancreatitis and pre-cancerous cell changes. Other drugs named in the Alert include Januvia, Janumet, Bydureon and Byetta.
These drugs are part of a class of type 2 diabetes drugs called incretin mimetics, because they work by mimicking the incretin hormones that the body uses to produce and stimulate the release of insulin. The FDA noted in its Alert that it was not yet changing the safety labels of these drugs, but that it was currently reviewing data from various studies evaluating the medications.
When Victoza was first approved in 2010, the FDA was aware of five clinical trials wherein there were seven separate cases of pancreatitis. Two years later, the watchdog group Public Citizen urged the agency to withdraw Victoza’s approval, citing the increased risk of not only pancreatitis but thyroid cancer and kidney problems as well. Public Citizen even went so far as to state that Victoza was approved against the advice of three FDA reviewers.
In fact, one of the directors inside the agency’s office of new drugs, Dr. Curtis Rosenbraugh, did overrule some of the other staff in approving the drug, including one reviewer for clinical safety. Dr. Karen Mahoney, the clinical safety reviewer, stated at the time that there were already more than ten different types of drugs approved for type 2 diabetes, and that Vicoza’s safety was largely uncertain.
Dr. Rosenbraugh argued that these uncertain safety issues could be addressed in studies once the drug was on market, and that Victoza was not any more risky than other incretin mimetics, such as Byetta. He said he was unwilling to keep a drug from patients to wait for years-long studies that may not even answer the concerns. He ultimately approved Victoza as a second-line drug, meant to be prescribed only to those patients who failed to react to other diabetes treatments.
Dr. Sidney Wolfe, the director of Public Citizen, stated that the approval
of Victoza was a major blow to the health and safety of American diabetics.
Wolfe is also the consumer representative on the FDA’s advisory
board for risk management and drug safety.
Victoza is the brand name for the generic liraglutide, and is one of Novo Nordisk’s biggest sellers, with sales of $370 million in the fourth quarter of 2011. A year before the drug’s approval, an advisory panel to the FDA raised questions about its safety, although the agency decided its benefits outweighed the risks.
In clinical trials on lab rodents, high doses of Victoza caused thyroid
tumors. As a condition of approval, the FDA required Novo Nordisk to conduct
a five-year trial to evaluate Victoza’s risk of pancreatitis development,
dangerously low blood sugar levels, allergic reactions, heart safety,
and thyroid and pancreatic cancer. That study is expected to be released
in 2015, although an official date has not yet been established.
Public Citizen analyzed the FDA’s complaint database and found that, in the first 17 months of Victoza being on market, 200 patients were diagnosed with acute pancreatitis. This number is believed to be significantly underreported, however, as complaints made to the FDA are voluntary.
Victoza lawyers at Pintas & Mullins Law Firm affirm that the drug’s label has recently changed to include the risk of kidney failure. If you were seriously injured by Victoza, or any other incretin mimetic, you may be entitled to significant compensation through a lawsuit against the drug’s manufacturer. Contact a skilled attorney as soon as possible for a free, no-obligation consultation.