Sibutramine Now Contraindicated in Patients With a History of Cardiovascular Disease

For years, I have been warning about the discoveries over time that will add to the list additional harmful effects of diet pills. Here is more about the IMHO malpractice known as diet drugs.

Sibutramine, marketed as Meridia in the United States by Abbott, is now contraindicated in patients with a history of cardiovascular disease, the US Food and Drug Administration (FDA) announced today.

According to an alert posted today by MedWatch, the FDA's safety information and adverse event reporting program, the announcement is a follow-up to an ongoing safety review of preliminary results reported in November 2009, which first raised concerns about this issue.

According to the FDA, the drug label already warns against the use of sibutramine in patients with cardiovascular disease. "However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label," stating that sibutramine should not be used in patients with a history of cardiovascular disease, including patients with a:

History of coronary artery disease (eg, myocardial infarction, angina)
History of stroke or transient ischemic attack
History of heart arrhythmias
History of congestive heart failure
History of peripheral arterial disease
Uncontrolled hypertension (eg, >145/90 mm Hg)

The safety review was based on data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT), which enrolled more than 10,000 overweight or obese patients with diabetes or a history of coronary artery disease, peripheral vascular disease, or stroke, along with other cardiovascular risk factors.

More to follow - you can be sure of that.