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FDA Approves Obesity Drug, Noting Possible Side Effects

By Marlene Cimons
Los Angeles Times
WASHINGTON

A scant two months after removing two popular diet drugs from the market, the U.S. Food and Drug Administration announced Monday that it has approved the first in a new generation of anti-obesity drugs that attack fat in a whole new way - but not without risk.

The new compound, sibutramine, which will be marketed under the name Meridia, works by enhancing the brain's natural appetite-regulating chemicals, allowing them to act longer.

But the new drug is not without side effects. Meridia can cause increases in blood pressure and, because it is believed to be psychologically and physically addictive, it is expected to be more tightly controlled and subject to regulation by the Drug Enforcement Administra-tion.

It is not expected to be available for several months because of its pending scrutiny by the DEA.

In September, the FDA removed fenfluramine, sold as Pondimin, and dexfenfluramine, sold as Redux, after their use was linked to potentially life-threatening heart valve problems. Fenfluramine was part of a widely used, although unapproved, drug combination known as fen-phen. The other drug, phentermine, is still on the market.

The banned drug dexfenfluramine worked by causing an increase in the release of the brain chemical serotonin, which made patients feel full.

The new drug, known as a neurotransmitter reuptake inhibitor, works outside the brain cells to prevent naturally produced serotonin from being re-absorbed, essentially making the feeling of fullness last longer.

Because Meridia can cause increases in blood pressure, the FDA recommended that individuals with uncontrolled high blood pressure, heart disease or an irregular heartbeat not take the drug.