FDA: Abbott's obesity drug could lead to increased cardiac risks
The FDA has warned that sibutamine (Meridia; Abbott Laboratories), a drug used to curb obesity and enhance weight loss, could lead to an increased risk of cardiac events in patients.
According to an FDA safety review, patient usage has been linked to heart attack, stroke, resuscitated cardiac arrest or death more than in patients administered a placebo.
An ongoing study analyzed 10,000 patients aged 55 and older who were categorized as overweight or obese and had a history of heart disease or type 2 diabetes plus one additional cardiac risk factor.
Meridia, approved in 1997 by the FDA, is only recommended for patients considered obese with a body mass index (BMI) greater than 30 kg/m2 or a BMI less than or equal to 27 kg/m2 in patientsdiagnosed with diabetes, high cholesterol and high blood pressure.
After the preliminary results, it was reported that patients using Meridia experienced an elevated number of cardiac problems compared to patients given the placebo pill. Cardiac events were reported in 11.4 percent of patients using the drug compared to 10 percent taking the placebo.
Although the FDA has issued warnings suggesting that Meridia should be avoided by patients with a history of heart disease, congestive heart failure, arrhythmias or stroke, they said that no conclusions are being made about the preliminary findings.
The FDA noted that it will be conducting an expedited safety review of the prescription drug. In addition, the FDA has urged healthcare professionals prescribing the medication and consumers taking it to report side-effects to the FDA’s MedWatch Adverse Event reporting program.
According to an FDA safety review, patient usage has been linked to heart attack, stroke, resuscitated cardiac arrest or death more than in patients administered a placebo.
An ongoing study analyzed 10,000 patients aged 55 and older who were categorized as overweight or obese and had a history of heart disease or type 2 diabetes plus one additional cardiac risk factor.
Meridia, approved in 1997 by the FDA, is only recommended for patients considered obese with a body mass index (BMI) greater than 30 kg/m2 or a BMI less than or equal to 27 kg/m2 in patientsdiagnosed with diabetes, high cholesterol and high blood pressure.
After the preliminary results, it was reported that patients using Meridia experienced an elevated number of cardiac problems compared to patients given the placebo pill. Cardiac events were reported in 11.4 percent of patients using the drug compared to 10 percent taking the placebo.
Although the FDA has issued warnings suggesting that Meridia should be avoided by patients with a history of heart disease, congestive heart failure, arrhythmias or stroke, they said that no conclusions are being made about the preliminary findings.
The FDA noted that it will be conducting an expedited safety review of the prescription drug. In addition, the FDA has urged healthcare professionals prescribing the medication and consumers taking it to report side-effects to the FDA’s MedWatch Adverse Event reporting program.