FDA notes heart events, tumors with Novo drug

Mar 31, 2009

(AP) -- Federal health officials say a potential blockbuster diabetes drug from Novo Nordisk appears to work. But they say questions remain about its effect on the heart and other organs.

Results from the Danish drugmaker show the liraglutide helped control blood sugar when used alone or in combination with other medications. But regulators have concerns about a small number of heart problems seen in patients as well as tumors when the drug was tested on rats and mice.

Novo Nordisk is hoping its once-a-day injection can take sales away from Byetta, a twice-a-day injection from Eli Lilly and Amylin Pharmaceuticals that has a similar formulation.

The FDA meets with its outside experts this week to review liraglutide and another drug looking to compete in the $5.1 billion U.S. market for diabetes drugs, which has grown rapidly as the disease becomes more prevalent.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: Tagging drugs to fight counterfeit medicines

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 approves new diabetes treatment

Oct 17, 2006

The U.S. Food and Drug Administration has approved the use of Januvia tablets as the first in a new class of diabetes drugs.

FDA to review Vytorin results

Jan 26, 2008

The U.S. Food and Drug Administration said it is conducting a review of the cholesterol drug Vytorin based on preliminary results from a recent study.

Recommended for you

Use new meningitis vaccines only for outbreaks

1 hour ago

(AP)—A U.S. panel on Thursday recommended that two new meningitis vaccines only be used for rare outbreaks, resisting tearful pleas to give it routinely to teens and college students.

New antibiotic avycaz approved

5 hours ago

(HealthDay)—The combination antibiotic Avycaz (ceftazidime-avibactam) has been approved by the U.S. Food and Drug Administration to treat adults with complicated infections of the intra-abdominal area or urinary tract, ...

Tagging drugs to fight counterfeit medicines

Feb 25, 2015

The U.S. and other countries are enacting rules to clamp down on the sales of fake pharmaceuticals, which pose a public health threat. But figuring out a system to track and authenticate legitimate drugs still faces significant ...

Watchdog group seeks FDA ban of antifungal tablets

Feb 24, 2015

(AP)—A consumer safety group is calling on the Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.

User comments : 0

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.