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(NaturalNews) U.S. health officials said on Friday they suspect Merck`s blockbuster diabetes drug Januvia to be linked to pancreatitis, a potentially fatal condition marked by serious inflammation of the pancreas. As might be expected, Merck company officials disputed the connection.

According to the Food and Drug Administration, 88 cases of acute pancreatitis had been reported since the drug`s approval in 2006 through February of this year by users of the drug and a related product Janumet, including two cases of hemorrhagic or necrotizing pancreatitis. The agency "believes there may be an association" with the drug, since 19 of the patients developed the condition soon after taking Januvia and more than half saw the condition disappear after they discontinued taking it.

The FDA further recommended that the medication should be used with caution and with appropriate monitoring in patients with a history of the condition. "Because acute pancreatitis is associated with considerable morbidity and mortality," the agency said, and "early recognition is important in reducing adverse health outcomes", the FDA is now recommending that the prescribing information be revised to alert healthcare professionals to the potentially serious side effect of pancreatitis."

Despite the apparent link, Dr. John Amatruda, a senior vice president of Merck`s diabetes and obesity unit, said: "We don`t believe that the data establishes a relationship" between the condition and the drugs, which both contain the active ingredient sitagliptin. "Patients with diabetes are twice as likely to develop pancreatitis even without medication," Amatruda noted.

Amatruda also said the company voluntarily updated the drug`s label in March because of post-marketing reports. He maintained that it is not possible to establish a link based on the reports, citing a range of variables which included whether diabetes patients have other conditions.

"Patients with type 2 diabetes are more likely to develop pancreatitis than other people, and as the FDA noted in a publication earlier this year, `diagnosis of drug-induced pancreatitis poses a challenge since it can be difficult to rule out other causes,`", Amatruda said.

Merck has a well-known history of making similar denials and vigorous defenses on behalf of other drug products that were later proven to have dangerous and even fatal side effects. Most notable was the killer drug Vioxx. Others have included Avandia, Fosamax and Gardasil.

A similar drug, Byetta, made by Merck Rival Amylin Pharmaceuticals, saw sales fall sharply in 208 after it was linked to acute pancreatitis. Meanwhile, worldwide sales of Merck`s Januvia rose 38 percent in the second quarter to $462 million and Merck has forecast 2009 combined sales of between $2.4 billion and $2.7 billion for the two drugs.

The company is awaiting a decision from the FDA on whether its diabetes drugs can be used with insulin in the United States. Both the Januvia and Janumet labels state that they have not been studied in combination with insulin.

Sources included:

http://www.healthiernews.com
http://in.reuters.com/article/rbssH...
http://www.forbes.com/feeds/ap/2009...

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