March 28, 2024
BANGOR DAILY NEWS (BANGOR, MAINE

FDA OKs diabetes drug despite side effect

WASHINGTON — The Food and Drug Administration has approved a new drug to treat diabetes, but warned Friday that patients must watch out for a dangerous side effect.

Metformin, manufactured by Lipha S.A. of France, will be sold here under the brand name Glucophage to treat noninsulin-dependent, or Type II, diabetes.

Some critics tried furiously to block approval of the drug, which the FDA said may cause some patients to suffer lactic acidosis, a life-threatening buildup of lactic acid in the blood.

About 14 million Americans have diabetes, where the body loses its ability to control levels of sugar in the blood. Left untreated, it can cause organ damage and even death.

Type II diabetes is the most common type, afflicting about 13 million Americans, only half of whom are diagnosed. They either don’t produce enough insulin, a hormone that regulates blood sugar, or can’t use it properly — or both.

The standard treatment is a strict low-sugar diet and weight loss. Those who don’t respond can take drugs that stimulate the pancreas to secrete more insulin.

Metformin works differently, increasing the body’s response to its own insulin. The drug appears to work as well as other diabetes drugs, but rarely causes the hypoglycemia — plummeting blood sugar — and weight gain that its alternatives do, said FDA’s Dr. James Bilstad.

“We’re excited,” said American Diabetes Association president Dr. Kathleen Wishner. “For some people, this drug will work better.”

Metformin is closely related to a diabetes medicine called phenformin that in 1977 became the only drug the United States ever banned as an “imminent hazard.” The FDA pulled phenformin because it caused hundreds of cases of lactic acidosis.


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