The label for the diet drug <"http://www.yourlawyer.com/topics/overview/meridia">Meridia will be updated to state that it isn’t to be used in patients with a history of heart disease, including heart attacks, uncontrolled hypertension and heart-rhythm problems. The Food & Drug Administration (FDA) announced the label change following a Meridia safety review it began in November, after a study indicated patients taking Meridia for weight loss are likelier to suffer cardiovascular events.
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).
In November, the FDA said that preliminary data from a study called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) suggested that patients using Meridia experienced a higher number of cardiovascular events compared to those using a placebo. The preliminary data showed that cardiovascular events were reported in 11.4% of patients using Meridia compared to 10% of patients using a placebo. According to the FDA Early Communication issued at the time, this difference was higher than expected, suggesting that Meridia is associated with an increased cardiovascular risk in the study population.
SCOUT, which began in 2002, involved approximately 10,000 patients who were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study.
Additional data from the SCOUT study reviewed by FDA indicate that the increased risk for cardiovascular events with Meridia occurred only in patients with a history of cardiovascular disease. As a result, the FDA today informed healthcare professionals that it had requested and Abbot Laboratories has agreed to add a new contraindication to the Meridia label. The contraindication will state that Meridia is not to be used in patients with a history of cardiovascular disease, including:
â€¢ History of coronary artery disease (e.g., heart attack, angina)
â€¢ History of stroke or transient ischemic attack (TIA)
â€¢ History of heart arrhythmias
â€¢ History of congestive heart failure
â€¢ History of peripheral arterial disease
â€¢ Uncontrolled hypertension (e.g., > 145/90 mmHg)
The FDA also advised that healthcare professionals regularly monitor the blood pressure and heart rate of patients using Meridia and if sustained increases in blood pressure and/or heart rate are observed, the drug should be discontinued. Additionally, the agency said Meridia should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk.
The FDA said patients currently using Meridia should talk with their healthcare professional to determine if continued use of the drug is appropriate and discuss any questions they may have about their treatment.