FDA raises the bar for new diabetes drugs
- From: kurtwheeling1965@xxxxxxxxxxx
- Date: Thu, 18 Dec 2008 19:57:14 -0800 (PST)
http://www.diabetes.org/diabetesnewsarticle.jsp?storyId=19109694&filename=20081217/ap20081217aponlineallD954NH8O0newsaporganpaewewEDIT.xml
or
http://tinyurl.com/4pakjh
(excerpt)
WASHINGTON - New drugs to treat an epidemic of diabetes will have to
be screened more closely for heart risks, federal health officials
said Wednesday.
The Food and Drug Administration's policy change should offer a
greater assurance of safety to doctors and patients. But it will make
it more costly and time-consuming for companies to develop drugs that
lower blood sugars. Well over 100 such medications are in some stage
of development.
"I think the FDA got this one right," said Dr. Steven Nissen, a
Cleveland Clinic cardiologist who raised the diabetes concern two
years ago with a study indicating a popular new drug increased the
risk of heart attacks. The medication, Avandia, remains on the market
amid continuing debate. But such drugs will have to clear a higher bar
in the future, the FDA said.
Some 23 million people in the U.S. have Type 2 diabetes, which is
considered an epidemic among adults, and a concern with teenagers and
even children. People with diabetes are unable to properly break down
carbohydrates, either because their bodies do not produce enough
insulin or because of resistance to insulin. As the years go by, they
are at higher risk for heart attacks, kidney problems, blindness and
other serious complications.
.
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