Meridia, popular diet drug manufactured by Abbott Laboratories, is now under the gun by lawyers. Cardiovascular disorders resulting from taking Meridia have been cited by the lawyers bringing the lawsuits. Abbott has disputed the validity of the statistics kept by the FDA and claims that the patient deaths cited by the lawyers have not been proven to be caused by taking Meridia.
Meridia, known as Sibutramine, is a medication commonly prescribed for patients as an anti-obesity medicine. Meridia is one of few remaining diet drugs still on the market. Unlike the diet drugs, Fenfluramine and Redux, which fooled patients' bodies into feeling full by boosting production of a brain chemical called serotonin, Meridia works by slowing the body's dissipation of the serotonin it naturally produces. Meridia is a type of drug termed an "SNRI" or Serotonin and Norepinephrine Re-uptake Inhibitor. It inhibits the reuptake of both chemicals in the brain that have been associated with satiety. Meridia was initially developed in 1980 as an anti-depressant, but Abbott never applied for FDA approval. During the initial development of the drug, however, defendants noted that Meridia had an ability to produce weight loss, and in 1990, Knoll began testing Meridia specifically as an anti-obesity agent.
On September 26, 1996, the FDA advisory committee declined to recommend approval of Meridia The FDA medical officer who reviewed the drug wrote that "Sibutramine has an unsatisfactory risk-benefit ratio, and, therefore, this reviewer recommends non-approval of the original submission." The committee also expressed concern about blood pressure increase experienced by study participants. Blood pressure and pulse rate rose considerably in a significant number of test subjects. This statistic was alarming as weight loss is expected to result in lower, not higher, readings. Nearly 15% of study participants experienced a 15 point systolic rise in blood pressure. Over 15% of study participants experienced a 10 point diastolic rise in blood pressure. A remarkable 25% of study participants saw a seriously increased pulse rate.
Most obesity experts agree that it is necessary to evaluate obesity treatments for periods of three to five years. The Meridia drug application data presented to the FDA was based on only a one-year study of 4,200 patients in the United States, the United Kingdom and France. In fact, the Meiridia testing period included the time during which weight loss actually occurred - usually not beyond the first six months of medication - so the test of weight maintenance was only about six months.
