Safety Alerts & Recalls
What does this mean?
If you are currently using MERIDIA (or the generic SIBUTRAMINE) you should talk with your healthcare provider to determine if continued use is appropriate, especially if you have a history of any of the cardiovascular conditions listed as a contraindication. If you continue using MERIDIA, you should visit your healthcare provider regularly to monitor your blood pressure and heart rate. You should also regularly review with your healthcare provider your total weight loss on MERIDIA and determine if the benefits of continuing the medication outweigh the risk of side effects.
If you have any other questions about this new safety information or if you think you are experiencing side effects from MERIDIA, please follow up with your healthcare provider right away.
Follow Up to FDA Ongoing Safety Review of SIBUTRAMINE, Marketed as MERIDIA
As first described in the November 2009 Early Communication, the U.S. Food and Drug Administration (FDA) has reviewed additional data that indicate an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using SIBUTRAMINE, marketed as the weight loss medication MERIDIA. The MERIDIA drug label already includes warnings against the use of MERIDIA in patients with cardiovascular disease. However, based on the serious nature of the review findings, the FDA requested and the manufacturer agreed to add a new contraindication to the MERIDIA drug label.
The contraindication will state that MERIDIA 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 (abnormal heart rhythms such as atrial fibrillation or ventricle tachycardia)
- History of congestive heart failure (CHF)
- History of peripheral arterial disease (PAD)
- Uncontrolled hypertension (e.g., high blood pressure > 145/90 mmHg)
The FDA expects additional study information about MERIDIA to become available in March 2010. Once the FDA completes its full, an open public advisory committee meeting will be held to discuss MERIDIA's benefit/risk profile and to determine if additional regulatory actions should be taken to ensure safe use of the medication.
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