The U.S. Food and Drug Administration announced approval of a new prescription obesity drug on Monday, filling a void created when two popular diet pills were banned in September.
Knoll Pharmaceutical Co.’s sibutramine, to be sold under the brand name Meridia, should hit the market within three months.
In approving Meridia, the FDA went against its own advisory committee, which was concerned about the drug’s tendency to increase blood pressure slightly in most patients - and significantly in a few. Obese people already are at risk of high blood pressure.
“We felt that, for the patients it’s indicated for, … the benefits outweigh the risks,” FDA spokeswoman Marian Segal said.
The FDA concluded that the blood pressure increase would be inconsequential for most users, that patients taking Meridia should monitor their blood pressure and that people with uncontrolled high blood pressure should not use the drug.
Studies found no link between Meridia and heart-valve damage, the problem that prompted the September recall of Redux, known chemically as dexfenfluramine, and Pondimin, known chemically as fenfluramine. Manufacturer Wyeth-Ayerst Laboratories of St. Davids, Pa., agreed to the recall after some physicians found heart-valve disease in up to one-third of patients using the products.
As do the banned drugs, Meridia suppresses appetite and creates a feeling of fullness by boosting a brain-signaling chemical called serotonin, but it does so in a way that seems to be safe.
Meridia slows the reabsorption of serotonin, while the other drugs trigger the release of extra serotonin.
Meridia also slows reabsorption of norephinephrine, a brain-signaling chemical that acts as a stimulant.
Psychologist Thomas Wadden, an obesity researcher at the University of Pennsylvania, said patients are clamoring for the new drug, particularly because it is intended for long-term use.
“Patients who were successful with Redux and Pondimin felt bereft when they were recalled,” Wadden said. “I think people will want to try this new medication, and I think many will find it’s a very good replacement.”
Meridia is not a magic cure. Like older drugs, Meridia caused a modest weight loss of 5 percent to 10 percent when combined with a reduced-calorie diet.
And like older drugs, Meridia is intended only for patients who are dangerously fat: at least 30 percent overweight. The FDA gave the example of a 5-foot-6 person who weighs at least 185 pounds, or who weighs at least 167 pounds and has weight-related health problems.
But FDA officials acknowledged that they could not stop doctors and patients from misusing the drug, as many did with Redux and Pondimin.
“People may use it who are not appropriate candidates,” said FDA medical officer Dr. Eric Colman. “But it’s not up to the FDA to regulate how physicians practice medicine.”
Dr. David Allison, an obesity researcher at St Luke’s-Roosevelt Hospital Center in New York, said: “We have found there is an appropriate role for drugs in the treatment of obesity. But the question of the day is: Will it be used appropriately?”