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Channel: Diabetes Living Today» Past Broadcast

5/27/08 ~ Dr. Stephen Sinclair, Retina Specialist

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This week Kitty and Dr. Fallon will interview Dr. Stephen Sinclair, Retina Specialist. They invite you to call in with your questions on diabetic eye disease. 

Stephen H. Sinclair, MD has served as the Chief Medical Officer and member of the Management Committee since the inception of Vimetrics, LLC in 2005. The technology of the Company represents more than 25 years of his basic and clinical research in retinal vascular disease and the vision that results. The current technology that is the basis for the patent portfolio encompasses unique vision measuring devices for children and adults and image processing algorithms for screening and following retinal diseases such as diabetic retinopathy and macular degeneration. He is an ophthalmologist in private practice specializing in diseases and surgery of the retina and since 1993 has remained adjunct Professor of Ophthalmology at Drexel University School of Medicine. Dr. Sinclair has received the Honor and Senior Achievement Awards for from the American Academy of Ophthalmology and has published more than 70 original scientific papers as well as lecturing for numerous organizations and universities throughout the world.

Photo Above: Dr. Stephen Sinclair

Listen to Diabetes Living Today interview:

5/27/08 ~  Dr. Stephen Sinclair, Retina Specialist


 


FDA studies possible pre-cancerous link with diabetes drugs!

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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.





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