A recent study suggests that the popular drug Meridia (sibutramine hydrochloride) — used for the management of obesity and weight loss — may have caused a higher number of heart attacks and/or strokes than patients using a placebo pill.
Although, the Food and Drug Administration (FDA) is currently reviewing the data collected from the study, the agency has yet to announce any regulatory actions that may be taken as a result.
Meridia, a prescription drug, was first approved by the FDA in 1997, and has since been used to assist in weight loss maintenance in conjunction with a low calorie diet for patients who are extremely obese and may be faced with a number of health risks due to their obesity; including diabetes and high cholesterol levels.
Nearly 10,000 patients took part in the Meridia study. Participants ranged from 55 years and older, were overweight and had a history of heart disease, diabetes and an additional cardiovascular risk factor. Based on study results, it was concluded that Meridia increases the risk of heart attack, stroke and/or a number of cardiovascular conditions that could lead to death.
The FDA has announced that it is expediting the review process due to the severity of this new data and will inform the public of its actions — if any — as soon as possible.
In the meantime, the FDA is asking patients using Meridia to consult their health care provider to determine if continued use is right for them. In addition, the FDA is urging doctors and patients who are using this drug to report any side effects by calling 1(800) 332 – 1088.
The lawyers of Aylstock, Witkin, Kreis and Overholtz are Florida’s top attorneys who have tried a number of drug safety cases. Contact the AWKO team at (888) 255 – 2956 to learn more about your rights as a consumer.
