Safety Alerts & Recalls
Search all Safety Alerts & Recalls
Latest Alerts
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.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm
Learn More
Endo Discontinues Making Moban (molindone hydrochloride)
Endo Pharmaceuticals, Inc. has notified the FDA that they have stopped making MOBAN (molindone hydrochloride) 5 mg, 10 mg, 25 mg and 50 mg tablets. Endo expects all MOBAN supplies to be depleted by June 30, 2010.
MOBAN contains the active ingredient molindone hydrochloride and is used in the treatment of schizophrenia.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm
Learn More