Consumer Group to FDA: Take Victoza off the Market
Consumer Watchdog Group 'Public Citizen' Challenges Safety of Popular Type 2 Diabetes Drug
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Victoza Maker Responds
The drug's maker, Novo Nordisk, disputes Public Citizen's claim that the drug should be pulled from the market.
"Novo Nordisk is committed to patient safety and rejects Public Citizen's assertion that the benefits of Victoza are outweighed by its risks," the company states in an email to WebMD. "In the two years since Victoza was approved, Novo Nordisk has continued to work closely with the FDA and the medical community to monitor the benefits and appropriate use of Victoza. Our experience in those two years does not support the Public Citizen call to deprive patients of the benefits of Victoza."
The FDA declined to comment. A representative of the agency said the FDA would respond directly to Public Citizen after reviewing the petition.
Victoza in Clinical Practice
Endocrinologist Suneil Koliwad, MD, PhD, says that plenty of drugs effectively treat type 2 diabetes, and he sees no reason to "aggressively defend" the use of Victoza. Compared to drugs that have long and proven safety records, he says, Victoza's safety is not thoroughly established, and he is particularly concerned about inflammation of the pancreas.
"The drug's trial was not long enough to see a sufficient safety record," says Koliwad, an assistant professor of medicine at the University of California San Francisco's Diabetes Center. "How rare is rare enough that we accept safety risks and still give this to our patients? Some medications we do give because they are the best available. Here that is not the case."
Koliwad says that some patients may benefit from Victoza and drugs in its class, but they should be thoroughly counseled prior to taking it. And he says that doctors should look at all of the available drugs before prescribing Victoza and similar medications. For those patients taking it already, Koliwad says they should stay on it if it works and is not causing problems.
"The primary concern should be that you are controlling your diabetes," says Koliwad.
Spyros Mezitis, MD, PhD, agrees.
"If there are no issues, we continue patients on the drug and we continue monitoring them while on it," says Mezitis, an endocrinologist at Lenox Hill Hospital in New York City who prescribes Victoza to patients only after a comprehensive discussion of their family health history, particularly regarding their thyroid.