Abbott has issued a Meridia Recall after being asked by the FDA to stop marketing the product in the United States due to results of a study indicating an increased risk of heart attack and stroke in Meridia users.
Meridia (sibutramine) is a prescription weight loss drug marketed and sold in the United Stages by Abbott Laboratories, who have removed their Meridia webpage and issued a Meridia recall statement on their website.
According to Abbott, he FDA’s request for Abbott to remove Meridia from the US market is based primarily on the results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study. This study researched about 10,000 patient, 6-year study requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. Abbot maintains that most of these patients “had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling“.
Patients should stop using Meridia (sibutramine) and consult their physician. Patients can also contact Abbott’s medical information line at: 1-866-257-8909.
The 5-year study showed that the average difference in body weight between people on Meridia and those on a placebo was about 2.5%, yet there was a 16% increase in the risk of non-fatal heart attacks and non-fatal strokes. This apparent risk-to-benefit ratio was not acceptable to the FDA, prompting a request to Abbot that they should “voluntarily” recall Merida.
The FDA has an FYI/COB (For your information / Cover Our Butts) page up here if you would like to learn more about the Meridia recall and how it isn’t their fault. Abbott also has an FYI/COB (mostly COB) page up here.
The recall of Meridia comes after a major label update earlier this year, which required Abbott to include the following contraindication statement:
Meridia (Sibutramine) is not to be used in patients with a history of cardiovascular disease, including:
- History of coronary artery disease (e.g., heart attack, angina)
- History of stroke or transient ischemic attack (TIA)
- History of heart arrhythmias
- History of congestive heart failure
- History of peripheral arterial disease
- Uncontrolled hypertension (e.g., > 145/90 mmHg)