FDA questions safety of experimental diabetes drug
July 15, 2011 By MATTHEW PERRONE , AP Health Writer in Medications
(AP) -- Federal health regulators have concerns about bladder and breast cancer seen in patients taking an experimental diabetes pill from Bristol-Myers Squibb and AstraZeneca.
The Food and Drug Administration said in an online review Friday that there were more cases of cancer among patients taking the company's drug than those taking a dummy pill. It was not clear whether the higher rate was caused by a statistical fluke or the drug itself.
A panel of FDA advisers meets next Tuesday to discuss the drug's safety and effectiveness. Along with cancer, the FDA will also ask the panel to comment on the drug's effects on kidney and liver function. FDA will make the final decision on the drug's approval.
Dapagliflozin is a once-a-day pill designed to help type 2 diabetes patients eliminate excess sugar in their urine. It differs from older drugs that decrease the amount of sugar absorbed from food. If approved, Bristol and AstraZeneca's drug would be a new option for diabetics, who must often rotate through several medications to control their disease.
But FDA scientists have concerns about the drug's safety, particularly after higher rates of bladder and breast cancer that were reported in company trials. The companies reported 10 bladder cancers among patients taking the drug compared with none on those taking a dummy pill. There were nine breast cancers compared with one in the control group. While neither study was designed to measure cancer risk, FDA scientists noted that the number of bladder cancers "significantly exceeded the rates expected" in diabetes patients.
Bristol-Myers and AstraZeneca have touted the drug as the first in a new class of drugs to address the nation's growing diabetes epidemic, which affects more than 25 million people.
In two-year studies of the drug, patients taking dapagliflozin had lower blood sugar levels and lost more weight than patients taking an older diabetes drug, Glucotrol.
But in its final conclusion the FDA said those results must be weighed against various safety concerns, including cancer, livery injury and bladder infection.
People with type 2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because of resistance to insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications.
Diabetics often require multiple drugs with different mechanisms of action to control their blood sugar levels.
New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca PLC already co-market the diabetes drug Onglyza, which increases insulin production while reducing glucose production.
©2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
-
FDA: Bristol-Myers diabetes drug appears safe
Mar 30, 2009 |
not rated yet |
0
-
Bristol-Myers gets EU approval for diabetes drug
Oct 05, 2009 |
not rated yet |
0
-
Medical societies respond to the FDA's safety announcement on the use of Actos
Jun 16, 2011 |
not rated yet |
0
-
FDA confirms benefits of Crestor in more patients
Dec 11, 2009 |
not rated yet |
0
-
FDA scrutinizes weight loss pill from Orexigen
Dec 03, 2010 |
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
-
Why is zone 1 in liver more prone to ischemic injury?
May 23, 2013
-
How can there be villous adenoma in colon, if there are no villi there
May 22, 2013
-
How can there be a term called "intestinal metaplasia" of stomach
May 21, 2013
-
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013
-
If you became brain-dead, would you want them to pull the plug?
May 17, 2013
-
MRI bill question
May 15, 2013
- More from Physics Forums - Medical Sciences
More news stories
Merck ends development of Parkinson's disease drug
(AP)—Merck & Co. says it is ending development of an experimental Parkinson's disease drug because the drug wasn't working.
Medications
16 hours ago |
1 / 5 (1) |
0
J&J expects 10-plus new drug applications by 2017
(AP)—Johnson & Johnson is developing what could eventually be game-changing treatments for depression and pain, and it's aiming to apply for approval of more than 10 new medicines by 2017, executives said Thursday during ...
Medications
17 hours ago |
5 / 5 (1) |
0
Experts favor US approval of Merck sleeping pill (Update)
An independent panel of experts on Wednesday recommended US approval of a new Merck sleeping pill called suvorexant, but expressed concerns over the highest dosage and risks of drowsy daytime driving.
Medications
May 22, 2013 |
not rated yet |
0
Glaxo, US partnering to develop new antibiotics
GlaxoSmithKline PLC says it's starting an unusual collaboration with the U.S. government to develop several antibiotics for both bioterrorism threats and bacterial infections resistant to current medicines.
Medications
May 22, 2013 |
not rated yet |
0
Study finds new pneumococcal vaccine appears to be as safe as previously used vaccine
The new 13-valent pneumococcal conjugate vaccine (PCV13) appears to be as safe as the previous version used prior to 2010, the 7-valent pneumococcal conjugate vaccine (PCV7), according to a Kaiser Permanente study published ...
Medications
May 22, 2013 |
not rated yet |
0
Scientists put bowel cancer under the microscope
Researchers from London's Kingston University have begun a two-year study which could help prolong the lives of people with colorectal tumours.
New neuron formation could increase capacity for new learning, at the expense of old memories
New research presented today shows that formation of new neurons in the hippocampus - a brain region known for its importance in learning and remembering - could cause forgetting of old memories by causing a reorganization ...
Are there atheists in foxholes? Study says they're the minority
Ernie Pyle – an iconic war correspondent in World War II – reportedly said "There are no atheists in foxholes." A new joint study between two brothers at Cornell and Virginia Wesleyan found that only ...
Saudi to send animal samples to US in coronavirus probe
Saudi Arabia said Friday it would send samples taken from animals possibly infected with a deadly SARS-like virus to the United States for testing in a bid to find the source of disease.
Engineered cytomegalovirus protects monkeys from HIV equivalent
(Medical Xpress)—A new study by researchers in the US has shown that an ancient virus can be modified to help in the fight against the simian immunodeficiency virus SIV, which is the equivalent in monkeys ...
Help at hand for people with schizophrenia
How can healthy people who hear voices help schizophrenics? Finding the answer for this is at the centre of research conducted at the University of Bergen.
Jul 15, 2011
Rank: not rated yet
Just take a look at Asprin. In the early stages of its use, Asprin was only approved for paid and the FDA banned its makers from advertising its potential to save lives if taken during and after a heart attack until further clinical studies were performed. Upon completion of additional clinical testing, Dr. Carl Pepine, the co-director of cardiovascular medicine at the University of Florida College of medicine estimated that ten thousand lives could have been saved yearly.
While the FDA has a responsibility to protect Americans