Public Citizen wants withdrawal of diabetes drug

April 19, 2012 By MATTHEW PERRONE , AP Health Writer

(AP) -- A consumer advocacy group is calling on government regulators to withdraw a diabetes drug from Novo Nordisk, saying the injectable medication raises the risk of thyroid cancer, pancreatitis and kidney failure.

Public Citizen sent a petition to the saying the risks of Victoza far outweigh its benefits as a , a crowded field that includes nearly a dozen similar medications.

Citing internal agency documents, the group notes that FDA approved the drug in 2010 against the recommendation of three staff scientists.

"The need for new therapies for Type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns," wrote reviewer Dr. Karen Mahoney, in an agency memo obtained by Public Citizen.

Mahoney and two other reviewers noted that Victoza caused thyroid tumors in both male and female rats and mice. The warning label for Victoza currently states it is "unknown whether Victoza will cause" in humans because rodent studies cannot provide conclusive evidence of human outcomes. The label recommends patients with a family history of the disease not use the drug.

The FDA reviews drugs using teams of doctors, pharmacists and scientists. It is not unusual for some team members to disagree on the safety of a drug.

Public Citizen also cites Victoza's association with pancreatitis, reports of which were 3.7-fold higher among patients tested with the drug than those taking other diabetes drugs. In its first 17 months on the market, the FDA received 200 reports of patients diagnosed with pancreatitis, according to a search of FDA databases. Public Citizen estimates only 10 percent of cases are reported to the agency, suggesting there may be as many as 2,000 cases of among patients taking Victoza.

About 150,000 prescriptions for the drug are filled each month in the U.S.

Any citizen or group can petition the FDA to remove a product from the market based on safety, economic or environmental reasons. The FDA often takes months or even years to render a decision on such requests.

Explore further: FDA questions safety of experimental diabetes drug

shares

Related Stories

Advocacy group seeks ban on pelvic surgical mesh

August 25, 2011

(AP) -- A consumer advocacy group is calling on government regulators to ban a type of surgical mesh used to treat pelvic collapse, saying it exposes patients to serious risks.

FDA panel backs Pfizer drug for kidney cancer

December 7, 2011

(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

Recommended for you

Engineered hot fat implants reduce weight gain in mice

August 20, 2015

Scientists at the University of California, Berkeley, have developed a novel way to engineer the growth and expansion of energy-burning "good" fat, and then found that this fat helped reduce weight gain and lower blood glucose ...

Promising progress for new treatment of type 1 diabetes

July 30, 2015

New research from Uppsala University shows promising progress in the use of anti-inflammatory cytokine for treatment of type 1 diabetes. The study, published in the open access journal Scientific Reports, reveals that administration ...

Bacteria may cause type 2 diabetes

June 1, 2015

Bacteria and viruses have an obvious role in causing infectious diseases, but microbes have also been identified as the surprising cause of other illnesses, including cervical cancer (Human papilloma virus) and stomach ulcers ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.