FDA probes new pancreas risks with diabetes drugs - MyFoxAustin.com | KTBC Fox 7 | News, Weather, Sports

FDA probes new pancreas risks with diabetes drugs

Posted: Updated:

By MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration is looking into new evidence that suggests a group of recently approved diabetes drugs can increase the risk of pancreatitis and other problems.

The agency said Thursday samples of pancreas tissue taken from a small number of patients showed inflammation and cellular changes that often precede cancer. Academic researchers took the samples from diabetes patients who were taking the new medications, after they died from various causes.

Details of the research have not yet been published, but the agency said in an online statement it is seeking more information.

While the FDA has issued previous alerts about the pancreatitis risk, the agency had not notified the public about pre-cancerous cell changes seen with the drugs.

For now, regulators say they are still investigating the issue.

"FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer," the agency said in an online statement. "At this time, patients should continue to take their medicine as directed until they talk to their health care professional."

The drugs under review come from a wave of recently approved diabetes medications, including Merck's Januvia and Janumet, Novo Nordisk's Victoza and Bristol-Myers Squibb's Byetta and Bydureon, among others. All the drugs mimic natural hormones that the body usually produces to spur insulin production after a meal.

Citi Investment Research analyst Andrew Baum told investors the investigation would likely have "minimal impact" on drug sales.  Similar investigations in recent years have not resulted in safety restrictions, he says.

"We believe that the likely worst case for the market incumbents is that the FDA could add additional warnings about increased risk of pancreas-related adverse events" Baum stated in a research note.

People with type 2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because they've become resistant to the hormone, which controls blood sugar levels. These patients are at higher risk for heart attacks, kidney problems, blindness and other serious complications.

Many diabetics require multiple drugs with different mechanisms of action to control their blood sugar levels.

With more than 25 million people living with diabetes in the U.S., some of the world's biggest drugmakers have launched new treatments in recent years, though safety questions have emerged.

The FDA previously added information about cases of pancreatitis, some of them fatal, to the labels of Byetta in 2007, and Januvia and Janumet in 2009.

A recent study of insurance records found that use of those drugs could double the risk of developing acute pancreatitis, according to the FDA.

Januvia is a once-a-day pill. Janumet combines the drug with metformin, a decades-old drug commonly prescribed for diabetes. Byetta is a twice-a-day injection originally developed by Amylin Pharmaceuticals. Bristol-Myers acquired the drug last year, along with the newer formulation Bydureon, which is taken once-a-week.

Byetta and Bydureon are part of a drug class that mimics the GLP-1 hormone, triggering insulin production after a meal.

Januvia and Janumet work by blocking the DPP-4 enzyme, which spurs release of more insulin from the pancreas. Those drugs brought in a total of about $5.75 billion last year, making them Merck's biggest franchise.

The pancreas produces various hormones, including insulin, that help the body break down sugar. Pancreatitis causes an inflammation of the organ and can lead to fatal complications, including difficulty breathing and kidney failure.

Shares of Whitehouse Station, N.J.-based Merck & Co. Inc. fell 32 cents to $44.27. Shares of New York-based Bristol-Myers Squibb Co. declined 1 cent to $38.48.

AP Business Writer Linda A. Johnson contributed to this story from Trenton, N.J.

--- 

A look at the diabetes drugs under investigation by the U.S.  Food and Drug Administration over possible risks of pancreas inflammation and cellular changes in the pancreas that occur before cancer.

DRUG CLASS: GLP-1 mimickers, taken by nearly 1 million Americans.

HOW THEY WORK: Injections needed anywhere from twice a day to once a week, they make the body produce more insulin to lower blood sugar.

MAKER: Bristol-Myers Squibb Co.

CHEMICAL/BRAND NAMES: exenatide/Byetta and Bydureon

MAKER: Novo Nordisk A/S:

CHEMICAL/BRAND NAMES: liraglutide/Victoza

___

DRUG CLASS: DPP-4 inhibitors, taken by about 1.6 million Americans.

HOW THEY WORK: Pills taken once or twice a day, they stimulate insulin production and limit release of a hormone that raises blood sugar levels.

MAKER: Merck & Co.

CHEMICAL/BRAND NAMES: sitagliptin/Januvia, Janumet, Janumet XR, Juvisync

MAKER: Bristol-Myers Squibb Co. & AstraZeneca PLC

CHEMICAL/BRAND NAMES:  saxagliptin/Onglyza and Kombiglyze

MAKER: Eli Lilly and Co. and  Boehringer Ingelheim Pharmaceuticals Inc.

CHEMICAL/BRAND NAMES: linagliptin/Jentadueto and Tradjenta

MAKER: Takeda Pharmaceuticals Co. Ltd.

CHEMICAL/BRAND NAMES: alogliptin/Nesina, Kazano and Oseni

___

Source: Company websites, health data firm Kantar Health.

Copyright 2013 The Associated Press.

  • HealthMore>>

  • Manhattan nursery school uses sanitizing machine to keep air clean

    Manhattan nursery school uses sanitizing machine to keep air clean

    Friday, July 25 2014 7:50 AM EDT2014-07-25 11:50:43 GMT
    All of us feel the same way about "cooties": Eww. At the Goddard School on the Upper West Side, a high-tech machine is keeping "cooties" out of the classroom. "This is the latest and then most effective sanitization method available today," says Bill Swan, the owner of the Goddard School. He purchased the ZONO Sanitech for his school about six months ago. The machine is the size of a double refrigerator and uses oxygen to kill viruses and bacteria.
    All of us feel the same way about "cooties": Eww. At the Goddard School on the Upper West Side, a high-tech machine is keeping "cooties" out of the classroom. "This is the latest and then most effective sanitization method available today," says Bill Swan, the owner of the Goddard School. He purchased the ZONO Sanitech for his school about six months ago. The machine is the size of a double refrigerator and uses oxygen to kill viruses and bacteria.
  • Should you ever ask a woman if she's pregnant?

    Should you ever ask a woman if she's pregnant?

    Friday, July 25 2014 5:52 AM EDT2014-07-25 09:52:11 GMT
    Is she or isn't she? How about her? Her? Him? (Looks it.) She definitely is. (I think.) Have you ever see a woman coming down the street and want to ask "Are you pregnant?" We human beings are curious creatures. It turns out even some 4-year-olds want to know. Justin Otero is now banned for life from the Doughnut Inn in Monroe, Connecticut. It was a harsh price to pay, some say, for such a seemingly innocent mistake.
    Is she or isn't she? How about her? Her? Him? (Looks it.) She definitely is. (I think.) Have you ever see a woman coming down the street and want to ask "Are you pregnant?" We human beings are curious creatures. It turns out even some 4-year-olds want to know. Justin Otero is now banned for life from the Doughnut Inn in Monroe, Connecticut. It was a harsh price to pay, some say, for such a seemingly innocent mistake.
  • Americans shop local and organic for health and ethics

    Americans shop local and organic for health and ethics

    Thursday, July 24 2014 6:13 PM EDT2014-07-24 22:13:49 GMT
    Five years ago, Sonia Zutic made a life-changing decision: she decided to eat with a conscience. Sonia is among a growing number of adults who swear by food that's strictly organic and free of additives and preservatives. Many have decided that ethical eating is no longer a trendy fad, but is a blueprint to life.
    Five years ago, Sonia Zutic made a life-changing decision: she decided to eat with a conscience. Sonia is among a growing number of adults who swear by food that's strictly organic and free of additives and preservatives. Many have decided that ethical eating is no longer a trendy fad, but is a blueprint to life.
Powered by WorldNow

KTBC FOX 7
119 East 10th Street
Austin, TX 78701

Phone: (512) 476-7777
Fax: (512) 495-7001

Didn't find what you were looking for?
All content © Copyright 2000 - 2014 Fox Television Stations, Inc. and Worldnow. All Rights Reserved.
Privacy Policy | Terms of Service | Ad Choices