FDA studies possible pre-cancerous link with diabetes drugs!

The Food and Drug Administration is studying unconfirmed reports that a widely used class of diabetes drugs, which includes Merck & Co’s Januvia, may cause inflammation of the pancreas and pre-cancerous changes to the pancreas.

The agency, in a notice on its website on Thursday, said this is the first time it has communicated potential pre-cancerous links to the medicines, known as incretin mimetics.

The drugs for type 2 diabetes also include Victoza from Danish drugmaker Novo Nordisk and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc.

Patients should continue taking their medicines as directed until speaking with healthcare professionals, the agency said. The FDA said it is investigating findings from academic researchers that highlighted the potential risk.

“These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes,” the agency said.

The FDA has asked the researchers to explain how they collected and studied the specimens and to provide tissue samples so the agency can further assess any possible risks.

In the meantime, the FDA said it has not reached any new conclusions about safety risks of the class of drugs.

The agency noted it has previously warned the public about acute pancreatitis, including fatal and nonfatal cases, seen with the medicines. Package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.

“It’s too early to tell, but we’ll keep an eye on it,” Edward Jones analyst Judson Clark said, when asked about the significance of the potential safety issues in Thursday’s FDA advisory.

But Clark said he did not expect any immediate changes in prescribing habits for the drugs because the pancreatitis risk is already noted on the drug labels.

The class of medicines, which mimic a natural hormone called incretin, prompt the pancreas to release insulin when blood sugar is rising. They are approved to treat type 2 diabetes, the most common form of diabetes which usually develops in adulthood and is closely linked to obesity.

Merck’s Januvia and its related drug, Janumet, had combined sales last year of almost $6 billion, making them by far the company’s biggest product franchise. Onglyza and a related drug called Kombiglyze had sales last year of $709 million.

Shares of Merck were down 1.1 percent at $44.08, while Bristol-Myers shares were down 0.8 percent at $38.18 on Thursday afternoon on the New York Stock Exchange. Shares of AstraZeneca were up 1 percent at $46.31, also on the NYSE. Novo Nordisk shares closed down 1 percent in Copenhagen.

Paula Deen: I Have Type 2 Diabetes

From fried chicken to mac and cheese casseroles, Paula Deen has made her mark on the culinary world – and in the homes of fans – with recipes that don’t skimp on cheese, cream and sugar. Not to mention butter … whole sticks of it.

And even as she reveals that she is living with Type 2 Diabetes, she says it won’t stop her from eating the way she wants.

“I was determined to share my positive approach and not let diabetes stand in the way of enjoying my life,” Deen said Tuesday in a release announcing her launch of Diabetes in a New Light™, geared toward finding “simple ways” to manage challenges of the disease.

“I’m excited to team up with Novo Nordisk on this initiative to show others that managing diabetes does not have to stop you from enjoying the things you love.”

The National Enquirer first reported Deen’s diabetes in April 2010, but she never confirmed or denied the diagnosis until now. She turns 65 Thursday.

The Food Network chef with the folksy Southern drawl – and a tendency to address her fans as “Hey, y’all” – has been famously criticized for her cooking techniques. Just last summer, fellow celeb chef Anthony Bourdain called her the “most dangerous person to America” who’s “proud of the fact that her food is f—— bad for you.”

And as news leaked she was making the announcement regarding her health, Bourdain was inundated with people “looking for quotes.” And he says he “takes no pleasure” in her news, telling Eater.com, he suspects she’s known for a long time and been looking for a way “to position herself.”

“When your signature dish is hamburger in between a doughnut, and you’ve been cheerfully selling this stuff knowing all along that you’ve got Type 2 Diabetes … It’s in bad taste if nothing else,” he said. “How long has she known? I suspect a very long time.”

Deen, it was also revealed in the release, takes Victoza – a once-daily, non-insulin injection – and continues to “make lifestyle adjustments, including lightened-up versions of her favorite recipes.”