FDA adds warning on Meridia label - Cardiovascular patients should avoid Sibutramine hydrochloride

A recent study of Meridia, or sibutramine hydrochloride, showed that it increases risks of heart attack or stroke in anyone who has a history of cardiovascular problems. After reviewing the study, the FDA asked the manufacturer of Meridia, a weight-loss drug, to add a warning to the label. The manufacturer, Knoll Pharmaceutical Company, has agreed to add the warning.

A history of cardiovascular disease makes Meridia/Reductil unsafe

According to the FDA, any history of cardiovascular problems increases the risk of heart attack or stroke when taking Meridia. The diet pill, also known as sibutramine hydrochloride, can be dangerous for anyone who has a history of heart attack, chest pain (angina), strokes, arrhythmia, or any other disorders affecting the cardiovascular system.

What does Meridia do?

Meridia, known as Reductil in the United Kingdom, is marketed as a weight-loss drug for the severely obese. According to Drugs.com, it is intended to assist in weight loss, when used with diet and exercise.

Meridia and the FDA

• In 1998, the FDA had to send Knoll Pharmaceutical Company a letter regarding misleading messages in a television advertisement.  1998 letter to Knoll from FDA regarding a misleading advertisement
• In November of 2009, the FDA began to review the safety of Sibutramine due to a study showing risks. Safety of Sibutramine
• Jan 21, FDA releases a follow up stating that a warning will be added to the label. FDA Follow-up