FDA staff: J&J diabetes drug may pose heart risk

Federal drug reviewers think Johnson & Johnson's experimental diabetes drug might bring heart risks because it raised cholesterol levels in patient testing.

In documents just released, Food and Drug Administration staff experts conclude studies showed canagliflozin (kann-AH'glih-floh-zin) slightly increased complications and risk of a urinary tract infection. That's because the pill works by boosting blood sugar excretion via urine.

The studies didn't find other serious problems, such as weakening of bones, damage to the liver or kidneys, or various cancers.

If the FDA approves the New Brunswick, N.J., company's , it would be the first in a new class of Type 2 diabetes medicines, called SGLT2 inhibitors.

Outside advisers to the FDA will review the data during a meeting Thursday and recommend whether the agency should approve canagliflozin.

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

Related Stories

Experimental diabetes drugs offer patients hope

Jun 11, 2012

Some experimental diabetes treatments in late testing offer patients hope of better controlling their blood sugar and weight and preventing dangerously low blood sugar, all big challenges for millions of diabetics.

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 backs Vytorin for kidney disease patients

Oct 31, 2011

(AP) -- The Food and Drug Administration says Merck's cholesterol drug Vytorin helps reduce heart attack, stroke and related problems in patients with kidney disease, a potential new use for the blockbuster drug.

Recommended for you

Health care M&A leads global deal surge

12 hours ago

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 ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

Nov 20, 2014

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

User 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.