Victoza FDA Stance
Victoza, a drug approved for the treatment of Type 2 diabetes, gained FDA approval in 2010 and was touted as an amazing new injectable diabetic drug which only required once-daily injections and was not dependent upon the food eaten or the level of activity. Over 26 million people in the United States are affected by diabetes therefore the market for diabetic drugs has literally skyrocketed. At the time Victoza was submitted by its manufacturer, Novo Nordisk, for FDA approval, there were two FDA pharmacologists and one FDA clinical safety reviewer who did not believe the drug warranted approval until further safety studies were conducted.
This stance was based in part on animal studies which suggested a link between a rare type of thyroid cancer and Victoza. When the FDA ignored the three who opposed the drug’s approval they released a statement which read in part, “The approval was a huge blow to the health and safety of diabetics in this country.” While the FDA panel approved Victoza they added a caveat that the drug should not be considered as a first line of defense drug for those with Type 2 diabetes and that those with a history of pancreatitis or thyroid cancer should consider one of the older types of diabetes drugs.
Victoza FDA Warnings
In the first seventeen months following the FDA approval of Victoza some 200 adverse reports came in to the FDA; because it is generally accepted that only 10% of consumers will report adverse health events to the FDA, the numbers were likely significantly higher. Public Citizen believes the risks of Victoza far outweigh the clinical benefits. Some research indicates that pancreatitis can occur from four to six times more often among Victoza users and pancreatic cancer approximately 2.9 times more often.
Victoza FDA Safety Concerns
Even though the FDA approved Victoza they did ask that Novo Nordisk provide a Risk Evaluation and Mitigation Strategy and a five year epidemiological study of the dangers related to Victoza. More recently the FDA took the relatively unusual step of opening a review of diabetic drugs including Victoza. The consumer advocacy group, Public Citizen asked the FDA in 2012 to remove Victoza from the market as it created a substantial risk of causing pancreatitis, pancreatic cancer, kidney failure, severe allergic reactions and pancreatic cancer.
Was There a Victoza Failure to Warn?
The FDA allowed Victoza to add data to their product label in 2012 stating Victoza demonstrated superior efficacy over Januvia, however also required that the potential risks of Victoza be stated on the label. Consumers were warned to speak with a doctor if they developed a lump or swelling in the neck, hoarseness, shortness of breath or trouble swallowing. This new labeling even warned patients that pancreatitis could result when taking Victoza and that the symptoms of pancreatitis could potentially be severe or even fatal. When lawsuits begin to be filed, it is likely many will allege a failure to warn on the part of Victoza’s manufacturer.
Will There Be a Victoza Potential Recall?
It is widely believed that a Victoza recall is only a matter of time and that lawsuits will follow, however at this time no recall has been issued and only two lawsuits have been filed, which also include the drugs Januvia and Byetta. Two patients developed pancreatic cancer after taking all three drugs for a number of years and have filed suit against all three manufacturers. Patients with a valid claim against the manufacturer of Victoza should speak to an experienced Victoza pancreatic cancer attorney.