FDA questions safety of experimental diabetes drug

By MATTHEW PERRONE , AP Health Writer

(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 said in an online review Friday that there were more cases of cancer among patients taking the company's drug than those taking a . 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 . 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 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 .

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 , 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 .

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.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA: Bristol-Myers diabetes drug appears safe

Mar 30, 2009

(AP) -- A potential blockbuster diabetes medication from Bristol-Myers Squibb appears free from heart-related side effects that have plagued similar treatments, federal health officials said Monday.

FDA confirms benefits of Crestor in more patients

Dec 11, 2009

(AP) -- Federal scientists say AstraZeneca's cholesterol pill Crestor lowers the risk of heart attack, death and stroke in patients without a history of heart disease, though some safety concerns remain.

FDA scrutinizes weight loss pill from Orexigen

Dec 03, 2010

(AP) -- Scientists for the Food and Drug Administration said Friday a pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn't meet all the criteria set forth by the agency.

Recommended for you

Powdered measles vaccine found safe in early clinical trials

13 hours ago

A measles vaccine made of fine dry powder and delivered with a puff of air triggered no adverse side effects in early human testing and it is likely effective, according to a paper to be published November 28 in the journal ...

Health care M&A leads global deal surge

Nov 23, 2014

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

User comments

Adjust slider to filter visible comments by rank

Display comments: newest first

Jesse_EngAmer
not rated yet Jul 15, 2011
Its good to see the FDA taking action against dangerous drugs, but lets bare in mind the FDA favors banning drugs over approving them. Approving dangerous drugs creates a huge backlash, but no one hears about the potential lifesaving drugs that are rejected. This fear leads to overregulation and overregulation creates a tendency to reject drugs or hold out for more research when in doubt that causes potentially life saving drugs to never reach the market.

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

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.