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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
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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
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Date Published Title Drug Source
2010-01-21 Follow Up to FDA Ongoing Safety Review of SIBUTRAMINE, Marketed as MERIDIA Sibutramine FDA
2010-01-20 Endo Discontinues Making Moban (molindone hydrochloride) Moban Manufacturer
2010-01-18 FDA Warns Consumers About Counterfeit Alli Orlistat FDA
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Aspirin Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Rolaids Multi-Symptom Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Calcium Carbonate with Magnesium Hydroxide Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Diphenhydramine Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Acetaminophen with Diphenhydramine Hydrochloride Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Acetaminophen Manufacturer
2010-01-15 Updated Information on Monitoring of Rapamune (Sirolimus) Drug Levels Sirolimus FDA
2010-01-15 Follow-Up to the FDA Safety Review of Tiotropium (marketed as Spiriva Handihaler) Tiotropium FDA
2010-01-07 Recall of Several Lots of Milk of Magnesia Cherry Liquid 12 ounce Bottles FDA
2009-12-29 Voluntary Recall of All Lots of Tylenol Arthritis Pain Caplet 100 Count Bottles Acetaminophen Manufacturer
2009-12-23 Voluntary Recall of 4.7 million Doses of Medimmune H1N1 Nasal Spray Vaccine Influenza A (H1N1) Vaccine Manufacturer
2009-12-23 Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) Ezetimibe FDA
2009-12-23 Follow-up to the FDA's Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) Ezetimibe with Simvastatin FDA
2009-12-21 Recall on Vicks DayQuil Cold & Flu Vicks Dayquil Manufacturer
2009-12-21 Recall on Vicks DayQuil Cold & Flu Manufacturer
2009-12-18 Recall of Several Lots of Yaz and Ocella Drospirenone with Ethinyl Estradiol FDA
2009-12-18 Recall of Several Lots of PREMPRO 0.3 mg/1.5 mg EZ-DIAL Dispensers Estrogens Conjugated with Medroxyprogesterone FDA