Diabetes Drug Approved by FDA Advisors
Holding out the possibility that many thousands of diabetics could reduce or even stop their insulin shots, the government’s scientific advisors recommended approval Wednesday of the first drug to attack the underlying cause of diabetes’ most common form.
Parke Davis’ Rezulin “is a truly novel approach,” said the Food and Drug Administration’s Dr. Solomon Sobel before an FDA advisory panel voted to support the drug.
Rezulin, known chemically as troglitazone, somehow resensitizes the body to insulin, a hormone that converts blood sugar into energy.
Researchers believe that it stimulates a gene to produce more insulin-controlled proteins that in turn remove this blood sugar, or glucose, from the bloodstream--essentially giving insulin more opportunity to do its job.
That makes Rezulin the only drug to attack the cause of Type II diabetes--the gradual loss of natural insulin’s ability to work--and as a bonus, decrease the body’s production of glucose.
About 16 million Americans have diabetes, although only half are diagnosed. Type I diabetes typically strikes children, who cannot produce any insulin and need shots of the hormone to survive. Rezulin should never be used by them.
But the vast majority of diabetics have Type II, also called adult-onset, or non-insulin dependent, diabetes. With this form, the pancreas produces more and more insulin but the body gradually stops reacting to it, letting blood sugar rise and risking kidney damage, blindness, heart disease and other complications.
Diet, exercise and pills to boost insulin production and decrease glucose production can help, but over 40% of Type II diabetics eventually need insulin shots. Even then, many can’t get high enough doses to stay healthy--or the inconvenience of taking shots and the weight gain the insulin can cause dissuade patients from taking proper care of themselves.
Only these poorly controlled Type II patients--an estimated 1 million people--should be considered for Rezulin treatment, the FDA panel decided.
