FDA probes new pancreas risks linked with diabetes drugs
WASHINGTON — The Food and Drug Administration is looking into new evidence that a group of recently approved diabetes drugs can increase the risk of pancreatitis and other problems.
The agency said 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 precancerous 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.
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 United States, some of the world's biggest drugmakers have introduced 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, 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.
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.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- Credit-card-stealing virus ‘Backoff’ virtually undetectable, Homeland Security warns
- Law enforcement, intelligence agencies want to ‘like’ you on social media
- Witnesses added for Benghazi hearing
- Congress considers dangers of driving high
- Target security officer says he was fired for reporting theft
- Cedar Point attraction mishap injures 2 riders
- Stoned volunteers test drug, alcohol effect on driving
- U.S. coal exports undermine energy efforts, experts say
- Tea Party opposition threatens House GOP’s border bill
- Ground Zero ship dated to 1773
- House’s vote to sue Obama is historic foray into checks, balances