Public Citizen wants withdrawal of diabetes drug
(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 Food and Drug Administration saying the risks of Victoza far outweigh its benefits as a diabetes drug, 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" thyroid cancer 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.
©2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- Advocacy group seeks ban on pelvic surgical mesh Aug 25, 2011 | not rated yet | 0
- High doses of Alzheimer's drug Aricept should be banned, Public Citizen says May 19, 2011 | not rated yet | 0
- Watchdog group makes 2nd push to ban diet pill Apr 18, 2011 | not rated yet | 0
- FDA panel backs Pfizer drug for kidney cancer Dec 07, 2011 | not rated yet | 0
- FDA questions safety of experimental diabetes drug Jul 15, 2011 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Is energy convertible to matter?
1 hour ago Can we convert energy to matter?
Rotating electron as a dipole is this right?
4 hours ago An electron as shown by the Stern Gerlach experiment behaves like a dipole (albeit only in one of two states). I have been trying to figure out how...
Dipole term in multipole expansion
8 hours ago Hi. I'm having some difficult in understanding something about the dipole term in a multipole expansion. Griffiths writes the expansion as a sum of...
Bubbles in a Pre-Boiling/Boiling pot of water
9 hours ago How is it that bubbles form on the bottom of a surface of a pot of boiling water? I think that there is probably an elementary answer to this...
Assumptions of Griffith's fracture theory
19 hours ago Any experts on Griffith's fracture theory? I am studying the subject and I am having hard time finding out if the theory is valid for all possible...
Current leading voltage or vice versa concept
21 hours ago Hello, I was wondering if there is a conceptual explanation for when current leads voltage or vice versa for capacitors or inductors with AC...
- More from Physics Forums - Classical Physics
More news stories
Study shows that women who smoke during pregnancy increase the risk of both obesity and gestational diabetes in their da
Women who smoke during pregnancy increase the risk of both obesity and gestational diabetes, in their daughters, concludes research published in Diabetologia, the journal of the European Association for the Study of Diabet ...
Diabetes May 20, 2013 | not rated yet | 0
The number of young people diagnosed with type 2 diabetes has seen the sharpest rise over the last twenty years compared to a background of a general increase across the board, new University research has ...
Diabetes May 20, 2013 | not rated yet | 0
(Medical Xpress)—Flinders University researchers are breaking new ground in a decade-long journey to pinpoint the function of two closely related proteins.
Diabetes May 20, 2013 | 5 / 5 (2) | 0 |
(HealthDay)—Moderate aerobic exercise prevents fructose-induced hypertriglyceridemia in healthy males, according to a study published online May 14 in Diabetes.
Diabetes May 17, 2013 | 5 / 5 (1) | 0 |
A DNA variant near a digestive enzyme does not only affect risk of developing diabetes but also affects the response to treatment, an international consortium of researchers including the University of Dundee has found.
Diabetes May 17, 2013 | not rated yet | 0 |
(Medical Xpress)—Native peoples in regions where cameras are uncommon sometimes react with caution when their picture is taken. The fear that something must have been stolen from them to create the photo ...
10 hours ago | 4 / 5 (4) | 0 |
(Medical Xpress)—Despite spending billions of dollars on research and development, drug companies have been unable to come up with effective treatments for dementia and Alzheimer's Disease (AD). Now, A. ...
8 hours ago | 4.8 / 5 (6) | 0 |
An experimental sleeping pill from US drug company Merck is effective at helping people fall and stay asleep, according to reviewers at the US Food and Drug Administration, which could soon approve the new drug.
4 hours ago | 5 / 5 (1) | 0
Activating an enzyme known to play a role in the anti-aging benefits of calorie restriction delays the loss of brain cells and preserves cognitive function in mice, according to a study published in the May ...
4 hours ago | 5 / 5 (3) | 0 |
Australian scientists have charted the path of insulin action in cells in precise detail like never before. This provides a comprehensive blueprint for understanding what goes wrong in diabetes.
10 hours ago | 4.8 / 5 (4) | 0 |
A drug commonly used to treat depression and anxiety may improve a stress-related heart condition in people with stable coronary heart disease, according to researchers at Duke Medicine.
5 hours ago | not rated yet | 0 |