Weight-Loss Drug Effective in 6-Month Teen Study
June 17, 2004 -- The weight-loss drug Meridia may help teens, a study sponsored by the drug's manufacturer shows.
Meridia is now prescribed only for adults. The drug, which increases the action of several chemical messengers in the brain, makes people feel they've had enough to eat, but does not reduce appetite.
The new six-month study looked at 60 obese Brazilian teens aged 14 to 17. All were put on a diet and exercise program. Half received once-daily Meridia, and half received a placebo.
Amelio F. de Godoy Matos, MD, of Catholic University in Rio de Janeiro, Brazil, reported the findings at this week's 64th annual meeting of the Endocrine Society in New Orleans.
After six months of treatment, two out of three teens taking Meridia -- but only one in 10 teens on placebo -- lost at least 10% of their body weight. Half the Meridia-treated teens, but none of those getting placebo, lost at least 15% of their body weight.
Average weight loss was 28.4 pounds in the Meridia group and 10.6 pounds in the placebo group.
"[Meridia] plus diet and moderate exercise induced significantly more weight loss in adolescents [than placebo]," Matos and colleagues note in their presentation abstract. "[Meridia was] demonstrated to be safe in the treatment of obese adolescents."
Although Meridia is suspected of increasing blood pressure and heart rate in some patients, these side effects weren't seen in this study. Teens taking Meridia suffered significantly more constipation than those taking placebo. Nevertheless, none of the participants dropped out of the study because of side effects.
Controversy Over Meridia Risks
The consumer group Public Citizen has twice petitioned the FDA to remove the drug from market, claiming that its risks far outweigh its benefits.
Public Citizen's September 2003 petition to the FDA cited 49 deaths from heart disease in Meridia users. Most of these deaths were in people under the age of 50. The petition also suggested that the drug might be linked to fetal defects in four babies born to women taking the drug.
But the American Obesity Association indicated that current statistical evidence shows that death rates linked to Meridia's are lower than the rate for persons with obesity overall. A number of experts reviewed the data referred to by Public Citizen and found no association between the drug and deaths.
Abbott Laboratories, which manufactures Meridia, points out heart deaths are not uncommon in obese patients. Indeed, clinical trials in more than 12,000 patients showed no sign that Meridia increased the risk of heart problems. The company maintains that, based on clinical trials and post-marketing data, the drug's proven benefits far outweigh any risks.