Byetta

Published on: July 30, 2013

Little Risk in Diabetes Drugs Says European Regulators

According to a recent news release, regulators in Europe have concluded that there is little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer.

Besides the European agency, the Food and Drug Administration has been reviewing the safety of a big class of drugs that includes Januvia by Merck and the drugs Byetta, Bydureon, and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca. These drugs, called incretin mimetics by the FDA, increase the body’s levels of a hormone that helps to control blood sugar levels.

They have, however, been linked to pancreatic inflammation known as pancreatitis. While the European agency said that the clinical trials had shown no increased risk of pancreatic cancer, the FDA said the trials were too small to draw firm conclusions.

Published on: March 11, 2013

Januvia, Byetta, and Pancreatic Cancer

By Ronald V. Miller, Jr.

Type-2 diabetes is the most prevalent form of diabetes in America. 25.8 million children and adults in the US are being treated for the condition. Each year almost 2 million more people are diagnosed. In 2012 alone, the treatment cost of type-2 diabetes in the United States was $176 billion.

Two new drugs, Januvia and Byetta, offer new ways of treating diabetes. By all accounts, they work well in treating diabetes. But these drugs have also been linked to increased rates of pancreatic cancer.

The Theory That Links Januvia and Byetta to Pancreatic Cancer

Published on: July 10, 2011

Bydureon

By Ronald V. Miller, Jr.

In the middle of a not so good stock market Friday after the jobs report, Amylin Pharmaceuticals went up 5% after a new study of its diabetes drug Bydureon took a step forward towards reaching the market.

Rezulin, Actos, Avandia… it seems there are a few diabetes drugs that have come on to the market with controversy and, yes, lawsuits. Is Bydureon different? I guess we will find out.

Our firm is now reviewing potential Bydureon lawsuits. Call us today for a free consultation. (I’m just kidding, by the way. Hopefully, Bydureon is a safe and efficacious drug that just helps people like the vast majority of drugs and medical devices.)

Published on: January 7, 2010

FDA Requires Animal And Human Studies For Byetta

By Miller & Zois

Tom Lamb and the Drug Injury Watch have a good article on the selective information given by Amylin Pharmaceuticals about their diabetes drug Byetta (co-marketed with Eli Lilly) to the media and their investors in October 2009. Apparently, they released the good information that the FDA approved it as a stand-alone medication for adults with type 2 diabetes. The only caveat was that the labeling would have to warn about the risk of pancreatitis in patients with severe kidney disease.

At the end of December, however, when the FDA letter to Amylin was obtained, a more complete picture emerged. It seems that the FDA also required human and animal studies to further investigate the risk of pancreatitis “to ensure that the benefits of the drug outweigh the risks of acute pancreatitis and acute renal failure.” These additional studies are necessary because “an analysis of spontaneous postmarketing adverse events reported . . . will not be sufficient to assess the signal of a serious risk of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis, and the signal of a serious risk of thyroid neoplasms.”

See also the Bloomberg article on the selective information given by Amylin, which goes into more detail about the effects on Amylin’s stock prices.

Published on: November 4, 2009

Byetta Kidney Injuries

By Miller & Zois

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Byetta, an injectable therapy for blood control of type-II diabetes patients manufactured by Amylin and Lilly, has been taking punches for links to pancreatic injuries. Now, a whole new line of injuries is entering the ring—kidney injuries.

The FDA has received post-marketing reports (complaints from patients and doctors after a drug is released to the public) that some patients have developed serious, life-threatening injuries while taking Byetta.