Public Citizen Calls for Victoza to be Banned by FDA
On April 19 of 2012, the watchdog group Public Citizen called for the FDA to remove Novo Nordisk’s Victoza (liraglutide) from the market. Their reasoning? Without any real benefit, the drug has major risks, namely thyroid tumors and cancer.
In its petition, the group states: “No information concerning the mechanism for this tumor-inducing effect of the drug in animals could rule out a similar risk to humans.”
During the approval process, several FDA pharmacology reviewers agreed, voting against approval because of the risk of thyroid cancer. However, despite reservations from reviewers, the FDA chose to approve the drug. Soon after, adverse even reports began rolling in, and the FDA added warnings, including a black box warning.
Public Citizen dealt with each side effect of Victoza separately, beginning with thyroid problems. Their researchers point out that there were drug-related increases in mice and rats of both genders at drug exposures similar to what humans would take. In addition, there was no tested dose at which increased rates of tumors were not seen.
The group stated: “Liraglutide is a drug that, in both mice and rats, had a stronger thyroid cancer signal than ever seen before for any drug (both approved and in the pipeline), including the other GLP-1 agonist, exenatide. Yet the FDA was willing to overrule the conclusion of its own pharmacologists and medical safety officer and disregard this information, even when combined with a clinical signal of increased risk in subjects in relevant short-term studies.”
Cardiovascularly, Victoza was found to decrease red blood cell counts and increase heart rate.
With regard to kidney problems, tests showed that liraglutide accumulated in the kidneys, meaning proper kidney function could be hindered.
Pancreatic complications were another major concern. The group found a 3.7 fold increased risk for pancreatitis in subjects taking Victoza compared to other drugs. Pancreatic inflammation was worst in females given high doses of the drug.
Public Citizen points out that the point of conducting these studies is to bring potential problems and dangers to the attention of the FDA, but despite all these red flags, the FDA seemed insistent on approving this drug. And unfortunately, the very side effects and adverse events that scientists were worried about began being reported almost immediately.
The group also points out that there are 11 different classes of drugs available to treat type 2 diabetes. There is no shortage of treatment options. Adding a new treatment option that does not offer a unique benefit but does offer serious and sometimes deadly side effects is unacceptable.
Manufacturer Novo Nordisk of course disagrees, stating that their drug provides a safe treatment option for diabetics.
The FDA has taken note of the rising number of complications reported with Victoza. This class of drugs is being studied for reported complications, however results may not be available for years, putting more and more people at risk of complications.
If you have taken Victoza and have suffered pancreatic, thyroid, or renal complications, contact an attorney from Kirkendall Dwyer LLP. We help hundreds of victims just like you get compensation. Let us help you.