Public Citizen is pushing for a Victoza recall in light of accumulating evidence that this diabetes drug exposes patients to the risk of pancreatitis, kidney damage, thyroid cancer, and other unacceptable risks considering the other available diabetes drugs on the market.
The cost/benefit is the critical point. Everyone understands drugs come with risks. But what Public Citizen is saying with Victoza is the degree of risk is not justified by the efficacy of the drug as compared to other treatments for diabetes.
No one is particularly shocked to hear calls for a Victoza recall. Geez, the FDA’s clinical safety reviewer was looking to recall Victoza before it ever came on the market citing the same logic Public Citizen is offering now: there are enough diabetes drugs already on the market and the side effects of Victoza during clinical trials did not justify putting the Victoza on the market.
The big concern during those trials was pancreatitis. There have been over 200 reports of pancreatitis. (There is a similar concern with Byetta and Januvia.)
But the concerns are growing upward and outward. The FDA has also expressed a concern of a the side effect of thyroid cancer with Victoza. In March 2010, the FDA warned that animal testing showed possible thyroid cancer links with Victoza and other GLP-1 therapies.
One sure sign that a drug is in trouble is when you start putting on additional warnings about 10 seconds after putting the drug on the market. Last June, a new warning was added to Victoza for a new side effect – kidney problems – on Victoza.
I think it is time to retire Victoza. If doing the right thing is not a motivating push for Novo Nordisk, let’s approach this from another angle: the perspective of a drug injury lawyer. The value of a lawsuit brought by patients who get one of these side effects from Victoza today are worth a great deal than Victoza patients that were hurt last year. Why? Because the information about the side effects of this drug are at an increasing rate. The evidence that Novo Nordisk should recall Victoza is clear. In six months, the evidence for a recall is going to be “hit you over the head with a hammer” clear. This increases the value of those later lawsuits. So, since we know Victoza is going to get recalled eventually anyway, can’t Novo Nordisk just cut to the chase and do it? Now.