UPDATE 2-FDA studies possible pre-cancerous link with diabetes drugs

* Studying unconfirmed findings from researchers

* Says has asked for samples of pancreatic tissue

* Says agency has not reached new conclusions on drugs

* Suggests patients remain on therapies

(Adds details on Victoza, drug class, diabetes, updates share prices)

By Ransdell Pierson

March 14 (Reuters) - The U.S. 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.

(Reporting by Ransdell Pierson in New York; Editing by Sofina Mirza-Reid and Matthew Lewis)

((ransdell.pierson@thomsonreuters.com)(646 223 6030)(Reuters Messaging: ransdell.pierson.thomsonreuters.com@reuters.net))

Keywords: DIABETES PANCREAS/FDA

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UPDATE 2-FDA studies possible pre-cancerous link with diabetes drugs

* Studying unconfirmed findings from researchers

* Says has asked for samples of pancreatic tissue

* Says agency has not reached new conclusions on drugs

* Suggests patients remain on therapies

(Adds details on Victoza, drug class, diabetes, updates share prices)

By Ransdell Pierson

March 14 (Reuters) - The U.S. 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.

(Reporting by Ransdell Pierson in New York; Editing by Sofina Mirza-Reid and Matthew Lewis)

((ransdell.pierson@thomsonreuters.com)(646 223 6030)(Reuters Messaging: ransdell.pierson.thomsonreuters.com@reuters.net))

Keywords: DIABETES PANCREAS/FDA

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Possible HIV exposure at Buffalo VA hospital

BUFFALO, N.Y. -- More than 700 patients at the Buffalo Veterans Administration Center may have been exposed to HIV, hepatitis B or hepatitis C because of accidental reuse of insulin pens, according to a hospital statement and published reports.

Authorities told The Buffalo News there is a "very small risk" for the diabetic patients who may have been exposed to the reused insulin pens between Oct. 19, 2010 and November 2012. The VA memo obtained by the News said the problem was discovered by a routine pharmacy inspection last Nov. 1. The News first published the report on its website Friday.

The VA also notified western New York members of Congress of the possible exposure.

In a statement to The Associated Press, VA spokeswoman Evangeline Conley said the hospital "recently discovered that in some cases, insulin pens were not labeled for individual patients." She added that "although the pen needles were always changed, an insulin pen may have been used on more than one patient."

Conley said that once this was discovered the hospital took "immediate action" to ensure the insulin pens were being used according to pharmaceutical guidelines.

Insulin pens used by diabetics to inject insulin can be disposable or reusable with replaceable needles and cartridges. But according to the Institute for Safe Medication Practices, even reusable pens should not be used on more than one patient.

After seeing the VA's memo, Rep. Chris Collins, a Republican who represents the Buffalo area, said he spoke with Dr. Robert A. Petzel, undersecretary for health at the Department of Veterans Affairs.

"His thought was that it's a very, very low chance of passing infection," Collins said. "But it's not out of the realm of possibility, and that's why they're testing everyone," Collins told the News.

Collins said that even with a fresh needle, contamination could have occurred if bodily fluid flowed back into the insulin pens.

The VA said it is offering free blood tests to rule out any infections.

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Shell Runs Its Arctic Drilling Rig Aground; Coast Guard Prepares For ‘Possible Spill-Response’

Photo: Jon Klingenberg / US Coast Guard

by Kiley Kroh

It appears 2013 will begin much like 2012 ended for Shell’s Arctic Ocean drilling efforts – with yet another mishap.

After several failed attempts to secure the equipment in harsh weather, Shell’s enormous Kulluk drilling rig ran aground near Kodiak Island, Alaska late Monday night. With approximately 143,000 gallons of fuel and 12,000 gallons of lubricating oil and hydraulic fluid on board, the Coast Guard is now preparing for the “salvage and possible spill-response phase of this event.” Two Coast Guard flyovers on Tuesday did not detect any leakage but a severe winter storm – with winds up to 70 mph and waves as high as 50 feet – has prevented crews from conducting a full assessment of the damage.

After an initial exploratory drilling season plagued with technical failures, struggles with Mother Nature, and numerous warnings about the lack of preparedness to operate in the region, the oil company’s woes have only continued. In November, the challenging and unpredictable Arctic conditions created a logistical nightmare as Shell struggled to get the Kulluk out of the Beaufort Sea as winter sea ice encroached.

As the Anchorage Daily News reports, the rig was headed to Seattle for maintenance last week when a mechanical failure in the tow vessel halted its progress and left “crews struggling against worsening weather and a mobile drilling unit that was unmanned with no propulsion capability of its own.” Huge winds and fierce swells thwarted numerous attempts to reattach tow lines and bring the rig to safety. Once grounding appeared inevitable, crews worked to steer the vessel to an area where it would have the least environmental impact.

Fortunately for Shell, this latest incident occurred in close proximity to the Coast Guard station in Kodiak, which enabled the helicopter rescue of 18 crew members on Saturday in extremely challenging conditions. The station also happens to be the closest permanent Coast Guard facility to where the oil company intends to use the Kulluk when they resume drilling this summer – over 1,000 miles away or 3 to 4 hours by plane in ideal conditions.

Like each of the incidents before it, the ongoing crisis with the Kulluk underscores the numerous challenges presented by operating in the Arctic, as well as the industry’s lack of preparedness to anticipate and overcome them. Drilling for oil in the Arctic Ocean carries an enormous amount of risk – a fact pointed out not just by environmentalists but a major insurance company, bank, legislative body, and even a fellow oil major among others.

As Rep. Ed Markey (D-MA) emphasized in a statement released Tuesday, “Oil companies keep saying they can conquer the Arctic, but the Arctic keeps disagreeing with the oil companies … Drilling expansion could prove disastrous for this sensitive environment.”

Problems with logistics, infrastructure, and scientific knowledge only add to a bigger problem: that the Arctic is already being battered by accelerating climate change. In the summer of 2012, the region lost a mass of ice the size of Canada and Texas combined.

Shell’s Arctic endeavor has been riddled with problems from the outset. As the company looks toward a full drilling season in 2013, there are far more questions than answers and far more mishaps than successes.

Watch a video of Shell’s stranded rig:

Coast Guard overflight of Kulluk aground from anchoragedailynews on Vimeo.

Kiley Kroh is the Associate Director for Ocean Communications at the Center for American Progress

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