FDA Urges Abbott to Recall Meridia
October 11, 2010
The weight-loss drug Meridia (sibutramine) has been recalled from the market by its manufacturer, Abbott Laboratories, at the request on Oct. 8, 2010, of the U.S. Food and Drug Administration (FDA).
The results of a recent study show that the risks of taking the medication far outweigh its benefits, according to an FDA safety announcement.
The study called SCOUT (for Sibutramine Cardiovascular Outcomes Trial) observed 10,000 patients over six years. The average difference in body weight between patients on Meridia compared to patients receiving a placebo was 2.5 percent. This compared to a 16 percent increase in the risk of non-fatal heart attacks and non-fatal strokes in the same group of patients.
Such a risk-to-benefit ratio is unacceptable, said the FDA.
Meridia, approved in November 1997, fared better in earlier clinical trials, although there was always a concern about adverse effects on heart rate and blood pressure. The SCOUT study was undertaken because of such earlier concerns.
The original clinical trial data were more favorable towards Meridia. Its approval was based on study results showing a 60 percent weight loss in Meridia patients compared to 30 percent of placebo-treated control subjects. Weight loss was defined as a loss greater than 5 percent of their body weight as measured when entering the study.
Because of concerns about a rise in blood pressure and heart rate among the original study subjects, a post marketing requirement of selling the drug in Europe was that the drug be tested in a cardiovascular outcome study. Thus, the SCOUT study was undertaken. Ten thousand subjects participated in this later study in Europe, Latin America and Australia. The trial was a randomized, double-blind, placebo-controlled study of men and women who were 55 years old or older and overweight.
The study subjects also had histories of at least one, if not more, of the following risk factors:
- An increase in waist circumference (a predictor of cardiovascular disease)
- History of cardiovascular disease
- Type 2 diabetes
- High blood pressure
- Abnormal blood lipid measurements
- Smoking
- Diabetic nephropathy (i.e., kidney disease secondary to diabetes)
Earlier this year, the FDA required Abbott to update Meridia’s label to include new contraindication information warning patients and doctors about using Meridia if they had the preceding risk factors.
The contraindication warned patients against using Meridia if they had a history of cardiovascular disease including a history of any of the following:
- Coronary artery disease such as a heart attack or angina
- Stroke or transient ischemic attack
- Heart arrhythmias
- Congestive heart failure
- Peripheral artery disease
- Uncontrolled hypertension (that is, greater than 145/90mmHg)
Meridia’s response to the FDA recall directive said that given the fact that the study subjects already had a major risk factor for heart disease — obesity — it should not be surprising that they showed an increased risk of high blood pressure and heart rate problems.
For more information or to speak with an attorney about a Meridia injury or death, contact a Meridia lawyer.
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