
DATE: Tuesday, November 25, 1997            TAG: 9711250602
SECTION: FRONT                   PAGE: A1   EDITION: FINAL 

SOURCE: FROM WIRE REPORTS 

DATELINE: WASHINGTON                        LENGTH:  105 lines

FDA BACKS ANTI-OBESITY DRUG; RISKS SPUR WARNING MERIDIA CAN RAISE BLOOD PRESSURE AND HAS BEEN FOUND TO BE ADDICTIVE.

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.

Knoll Pharmaceutical's Meridia is ``moderately effective'' at helping patients shed pounds - in studies, they lost about 7 to 11 more pounds than those that only dieted, the FDA said Monday.

But the new drug is not without side effects. Meridia can increase 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 Administration.

``We still have some concern,'' said FDA's Dr. James Bilstad, who urged doctors to rigorously check patients' blood pressure and pulse - and to prescribe it only to the seriously obese. ``This drug should not be used for those who want to lose simply a few pounds.''

Measured by a body mass index - the relationship of weight to height - someone is considered to be seriously obese if that index is 30 or greater.

While pointing out the risks, the FDA said Meridia does not appear to pose the risk of heart valve damage that forced September's ban of the nation's most popular diet drugs, Redux and fenfluramine.

The most common side effects of the new drug are a dry mouth, headaches, constipation and sleeplessness.

Despite Meridia's promise, one expert cautioned that the new drug won't work miracles.

``There will never be a drug that jumps out of your body and shuts the refrigerator door,'' said David Heber of the University of California, Los Angeles, Department of Human Nutrition, who conducted clinical trials on the new drug.

The agency approved Meridia Saturday night over the objections of its own scientific advisers, who called the drug too risky.

The advisory panel initially recommended against approval of the drug because of worries about blood pressure and pulse rate increases. The company came back to the agency with more in-depth analyses of its data that the FDA said answered its concerns. So the agency ultimately allowed the drug to come to market with warnings that patients' health should be closely monitored.

But because of Meridia's side effects, no one with poorly controlled hypertension, heart disease or irregular heartbeat or who has survived a stroke should use the drug, the FDA cautioned.

Knoll cannot sell Meridia for a few more months. The Drug Enforcement Administration is determining how strictly to control prescriptions after the FDA determined Meridia could pose a small risk of addiction and recommended limiting refills unless patients first return to a doctor.

Anti-obesity drugs have come under heavy scrutiny since companies voluntarily pulled the drugs dexfenfluamine (Redux) and fenfluramine (Pondimin) from the market after evidence emerged that they may be causing potentially fatal heart-valve damage complications.

Fenfluramine is the ``Fen'' in the widely-prescribed diet drug combination known as ``fen/phen.'' The combination was never approved as a therapy by the FDA. But since both drugs were individually approved, doctors could legally prescribe them ``off label.'' More than a million people took the drugs before the withdrawal.

The newly approved drug works by blocking the absorption, or ``reuptake,'' of two messenger chemicals in the brain, serotonin and norepinephrine. When serotonin hangs around longer in the brain before being reabsorbed, it curbs appetite.

Dexfenfluramine, by contrast, achieves the same result by increasing the release of serotonin from nerve cells; some scientists have suggested that the increased production of the body chemical might be behind the side effects. After information about those side effects emerged, sibutramine patients were tested for heart damage, and none was found.

Some 58 million Americans are overweight, and obesity experts welcomed Meridia as a desperately needed option - particularly after September's ban.

``It's great news for dieters,'' said Dr. John Foreyt of the Baylor College of Medicine.

But Foreyt said he hoped September's diet-drug scare had convinced dieters that Meridia is only for the seriously obese. ``It's not to be used willy-nilly,'' Foreyt said. Plus, Meridia ``will not help in the absence of changing your diet and being a little more active.''

Consumer activists urged Meridia users not just to see a doctor for regular blood pressure tests, but to check themselves regularly with an at-home blood pressure monitor.

``If you catch a rise, you can stop it'' by not taking the drug, said Lynn McAfee of the Council on Size and Weight Discrimination. ``People have to be responsible about this.'' MEMO: This story was compiled from reports by the Los Angeles Times, the

Associated Press and the Washington Post. ILLUSTRATION: Graphic

THE DRUG

How it works: Sibutramine, which will be marketed as Meridia,

enhances the brain's natural appetite-regulating chemicals, allowing

them to act longer.

Side effects: Most common are a dry mouth, headaches,

constipation and sleeplessness. Meridia can, however, increase blood

pressure and can be psychologically and physically addictive.

Availability: Not for a few more months. KEYWORDS: DIET DRUGS