FDA Approval Pushed for Victoza?

A nonprofit consumer advocacy group, Public Citizen, claims Victoza, a drug manufactured for the treatment of type-2 diabetes, gained FDA approval in 2010 against the advice of three reviewers. In fact, Dr. Sidney Wolfe, director of the group, believes the approval of Victoza was a “huge blow to the health and safety of diabetics in this country.” Dr. Wolfe also serves on the FDA advisory panel for drug safety as a consumer representative. Novo Nordisk, the manufacturer of Victoza states they reviewed data from over 4,000 patients prior to approving Victoza and the public should feel confident in the drug’s safety.

Victoza happens to be Novo Nordisk’s biggest seller with global sales of over $370 million per quarter and over 150,000 prescriptions filled for Victoza in the U.S. each month. Novo Nordisk hopes to gain U.S. approval for Victoza as a treatment for obesity by 2014 however the reports of adverse health effects may put an end to those hopes. Clinical trials of Victoza clearly showed that inflammation of the pancreas occurred more often in Victoza—and other diabetes drugs which worked in the same manner by mimicking the human hormone GLP-1—than with other diabetes drugs. Further, higher dosages of Victoza were found to cause thyroid tumors in laboratory animals.

Although the FDA approved Victoza in 2010, they added a requirement to the approval that Novo Nordisk undertake a five-year study which would determine the risks of pancreatitis, hypoglycemia, serious allergic reactions and pancreatic and thyroid cancers. According to documents found on the FDA’s website, an FDA director overruled other staff including the safety reviewer when it was being decided whether Victoza would be approved. The safety reviewer, Dr. Karen Mahoney, stated that as there were already eleven different types of type-2 diabetes drugs in use, there was no urgency to approve a drug with questionable safety.

Within the first year and a half following Victoza’s FDA approval, at least 200 people who took the drug developed acute pancreatitis. Since it is widely believed that only about 10% of all consumers will report adverse effects from a drug or medical device it is likely these 200 people were only the tip of the iceberg. Following these 200 reports, the FDA required a change in Victoza labeling to note the increased risk of kidney failure. Victoza currently carries a Black Box Warning which cautions users regarding the risk of kidney failure, thyroid cancer and pancreatitis. Other studies have linked Victoza to painful urination, swelling in the neck, pain in the stomach and back and shortness of breath.

It appears at this time that Victoza puts patients at three times the normal risk of papillary thyroid cancer and two and a half times the normal risk of thyroid C-cell hyperplasia. Patients using Victoza could be nearly four times more prone to develop pancreatitis which has been shown to be a risk factor in the development of pancreatic cancer. Victoza patients are twice as vulnerable to developing gastrointestinal side effects including diarrhea, constipation, abdominal pain, dehydration, nausea and vomiting. When taken with some other diabetic drugs, Victoza could cause hypoglycemia. Headaches, dizziness and nausea are the most common side effects of Victoza although a frequent occurrence of upper respiratory tract infections has also been noted.

Any patient who has taken Victoza—or a similar diabetic drug—and developed serious side effects from the drug, may need experienced Victoza attorneys to assist them in getting compensation for the harm they suffered from a drug they were told was safe. The attorneys of Sullo & Sullo, LLP, can help these individuals, using their skill and knowledge of product liability cases—Victoza in particular—to assist in getting consumers harmed by the drug medical expenses, lost wages and compensation for pain and suffering. Novo Nordisk may have failed to warn Victoza patients about the potential risks associated with the drug, causing damages to those who took the drug, and our attorneys will fight zealously on behalf of their clients.