FDA to Investigate Diabetes Drugs for Po

March 21 [Thu], 2013, 22:42
The U.S. Food and Drug Administration is investigating new unpublished research by a group of scientists that shows a possible link between a class of diabetes drugs known as incretin mimetics and an increased risk of developing pancreatitis or pre-cancerous cells. According to aon Thursday, the FDA intends to look at the research and the pancreatic samples used by the scientists in their study in order to "further investigate" the questions raised by the team's initial findings.

The FDA was quick to note in its statement that it "has not reached any conclusions" in regards to the research team's findings and that patients with diabetes should continue taking all their medications. Incretin mimetic drugs are manufactured by several different pharmaceutical companies in the U.S.

Here is some of the key information that emerged from the FDA's statement on Thursday and the research surrounding incretin mimetics.

* Incretin mimetics are a particular class of diabetes drug that mimic hormones that are supposed to instruct the body to produce insulin in order to keep blood sugar levels even after a person eats a meal. They are used to treat people with type 2 diabetes.

* Incretin mimetics are marketed under several different brand names, including Byetta, Januvia, and Janumet, and Victoza. They are also marketed as Bydureon, Juvisync, Kazano, Kombiglyze XR, Nesina, Onglyza, and Tradjenta, and Oseni,

* Many of the big pharmaceutical companies, including Merck, Bristol-Myer Squibbs, and Novo Nordisk, manufacture one or more varieties of incretin mimetics.

*that the FDA has previously warned the public about an increased risk of developing pancreatitis that is associated with long-term usage of incretin mimetics, and the labels on Byetta, Januvia, and Janumet are all required to include such a warning as well. However, this is the first time that the FDA has announced that it is investigating the drugs for the possibility that they may influence a person's risk of developing pancreatic cancer.

* Some analysts are brushing off concerns that the FDA's investigation will cause any long-term damage to sales of the drugs, however. The Associated Press on Thursday quoted Citi Investment Research's Andrew Baum, who told the media that his firm believes that the FDA's concerns will cause "minimal impact," and that "the likely worst case for the market incumbents is that the FDA could add additional warnings about increased risk of pancreas-related adverse events."

Vanessa Evans is musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.



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