European regulators are warning that <"http://www.yourlawyer.com/topics/overview/meridia">Meridia, Abbott Laboratories’ popular diet drug, should be used with caution because it may be tied to an increased risk of heart attack and stroke. The announcement by the European Medicines Agency (EMEA) comes nearly a month after the U.S. Food & Drug Administration (FDA) said it was reviewing the safety of Meridia because of similar concerns.
Meridia (sibutramine) was approved by the FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. It is only recommended for obese patients with an initial body mass index (BMI) â‰¥ 30 kg/m2, or BMI â‰¥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).
The recent action by both the FDA and EMEA was prompted by analysis of preliminary data from a study called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT). Part of a post-approval commitment between the EMEA and Abbott Labs, SCOUT was designed to show that weight loss with Meridia and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care. According to an FDA Early Communication issued in November, that analysis indicated that patients using sibutramine experienced a higher number of cardiovascular events compared to those using a placebo
In a press release issued December 18, the EMEA said it is reviewing data from SCOUT that indicate an increased risk of serious cardiovascular events, such as stroke or heart attack, with medicines containing sibutramine. In Europe, such products are sold under the brand names Reductil, Reduxade and Zelium.
The EMEA reminded doctors and patients to use sibutramine-containing medicines with caution, and only in accordance with the currently approved product information. In particular, the agency said these medicines should not be used in patients with coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia and cerebrovascular disease (stroke or transient ischemic attack). All patients should be regularly monitored for increases in blood pressure and heart rate. Patients who do not lose at least 5% of their body weight within 3 months should stop treatment. The maximum treatment duration should not exceed one year.