Based on FDA recommendations, drug maker Abbott has agreed to pull the obesity drug Meridia off the market in the United States. The FDA recommended its removal after reviewing the data from the most recent cardiovascular study indicated increased risk of heart attack or stroke. The study involved nearly 10,000 men and women chosen within a specific BMI range and with a history of CV disease and/or risk factors. The result was a 16% increase in CV events in the test group over those taking the placebo.
The FDA spokesman suggested that the increase was too great, and the weight loss “very modest”, which led to the decision to suggest removal of the drug from the market. Abbott originally marketed the drug with the contention that CV risks could be predicted for specific patient groups and avoided in those cases. The study results indicated that the risks were not specific to certain groups so it is impossible for physicians to determine who may or may not suffer from CV events as a result of taking the drug.