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FDA Orders New Safety Information on Diabetes Drug for Cancer and Pancreatitis Risk

By June 16, 2011July 18th, 2019Dangerous Drugs

As a dangerous drug attorney, I know the newer crop of diabetes drugs has had its share of problems. So I was disappointed but not too surprised to see that the FDA has issued a new safety warning for the diabetes drug Victoza/liraglutide. Victoza is an injectable drug that is supposed to work together with diet and exercise to fight Type II diabetes, although recent research suggests it could also be used in Type I diabetes. After turning up evidence that doctors were prescribing it as a first line treatment, against recommendations, the FDA ordered manufacturer Novo Nordisk to send letters to doctors reminding them that Victoza poses an elevated risk of pancreatitis and thyroid cancer. It asked doctors to monitor Victoza patients for signs of those diseases.
Victoza was approved in early 2010, but the approval vote was split because of evidence that it increases risk of thyroid cancer in laboratory animals. The FDA allowed the drug to be approved but told doctors that it should be used only if other treatments are ineffective. Pre-approval trials found that Victoza is effective and even seemed to cause weight loss, but also increased the risk of pancreatitis and thyroid cancer over control groups. The thyroid cancer risk rose with the size of the dose and the length of treatment. The FDA did not require doctors to monitor patients for signs of thyroid problems or pancreatitis, but advised them to send patients for testing if those signs show up. Novo Nordisk was required to conduct another study and start a thyroid cancer registry.
At first glance, none of this is news — the FDA is merely reiterating its cautions. However, as a defective drug lawyer, I’m disturbed that the FDA is only reiterating those cautions after discovering that some doctors didn’t pay attention the first time. Cancer and pancreatitis are both major health problems that could kill the patient or reduce quality of life for good. Patients and doctors should be well advised about these risks before they choose Victoza over another diabetes drug. If more active patient monitoring for signs of cancer is what it takes to remind doctors of the risk, perhaps the FDA should consider ordering that monitoring. And Novo Nordisk should continue its (required) efforts to warn patients, because any attempt to hide this kind of safety information could leave it open to a defective drug lawsuit.

Based in St. Louis, Carey, Danis & Lowe represents clients who were seriously injured, sickened or lost a family member because of a serious safety flaw in a prescription or over-the-counter drug. That includes drugs that are inherently dangerous as well as failure by manufacturers to adequately warn patients of the risks they face. Patients need accurate information from drug manufacturers in order to make good decisions; otherwise, we can only trust that what we’re given is safe, and unfortunately, that’s not always true. Our pharmaceutical liability attorneys help victims of dangerous drugs sue the manufacturer for the personal and financial results: medical bills, lost income and loss of a loved one or quality of life.
If you or someone you love was seriously hurt by a pharmaceutical product you thought you could trust, don’t hesitate to contact Carey, Danis & Lowe to find out how we can help. For a free, confidential case evaluation, send us an email or call 1-877-678-3400 today.