- June 28, 2008
The FDA is considering tougher standards for new and current diabetes drugs, raising concern in the pharmaceutical industry that the agency may ultimately raise the time and cost needed to approve of a wide array of new drugs.
The FDA is weighing whether to insist that new diabetes drugs have a positive impact on cardiovascular disease and life span, which are more difficult to measure than current benchmarks such as lower blood sugar.
[Story at Wall Street Journal:
Diabetes Drugs Face Tougher Rules: FDA Is Weighing Mandated Benefit To Heart, Life Span.]
- June 22, 2008
Scientists have found that diabetes contributes to depression. This has confirmed long-held assumptions about these two diseases being connected to each other that affect million of Americans. The research results provides added proof that diabetes plays a role in depression and vice versa.
Examining a Bidirectional Association Between Depressive Symptoms and Diabetes.
JAMA. 2008;299(23):2751-2759.
[Story at HealthNews; full text at
JAMA.]
- June 15, 2008
The Food and Drug Administration offered some explanation why a boxed warning has
been added to the label of Regranex Gel 0.01% (becaplermin), which is used by diabetes patients to treat foot ulcers.
The decision is based on a study that compared 1,622 diabetes patients exposed to Regranex with 2,809 otherwise similar patients for cancer incidence and cancer death.
The study found
the cancer deaths in the Regranex group were five times higher than that in the control group.
[Story at foodconsumer.org:
Warning for Regranex-Cream for Leg and Foot Ulcers.
Also see the FDA discussion at its website: Update of Safety Review
Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin).]
- June 8, 2008
Researchers who compared two diabetes trials they are getting some insight into why patients in one were more likely to die after aggressive treatment, while patients in another were not.
Weight gain, the use of multiple drug combinations and perhaps even getting blood sugar too low, too fast may all have been factors in causing early deaths, experts said.
[Story at Reuters:
Two diabetes trials shed a little light on deaths.
See earlier discussion at
ADVANCE and ACCORD and A1C.]
- June 1, 2008
Better screening and diagnosis for diabetes is needed to help find the 6.2 million Americans who don't realize they have the disease.
A New Look at Screening and Diagnosing Diabetes Mellitus.
J Clin Endocrinol Metab published May 6, 2008 as doi:10.1210/jc.2007-2174
[Story at WashingtonPost.com:
Abstract at
JCEM;
full text at
JCEM (PDF file)]
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