Safety Alerts & Recalls
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Drug Interaction Warnings Added to Prescribing Information for Seroquel
The FDA has requested that AstraZeneca add a new heart warning to the labels of its antipsychotic medicine Seroquel and the extended-release Seroquel XR. The new prescribing information label will recommend that patients should avoid use of Seroquel and Seroquel XR in combination with 12 drugs linked to abnormal heart rhythms (also known as arrhythmias). The abnormal heart rhythm, known as prolongation of the QT interval, can cause sudden cardiac arrest, a condition where the heart stops beating.
The updated prescribing information lists the other drugs to avoid including: antiarrhythmic drugs like quinidine, procainamide, amiodarone (Cordarone, Nextarone, Pacerone) and sotalol (Betapace); antipsychotic drugs like ziprasidone (Geodon), chlorpromazine and thioridazine; antibiotics like gatifloxacin (Zymar, and Zymaxid) and moxifloxacin (Avelox); the anti-infective drug pentamidine (Pentam); and synthetic opioids like levomethadyl acetate and methadone (Dolophine, Methadose). The label also raises caution about use by the aged and people with heart disease.
For more information, please visit:
http://www.nytimes.com/2011/07/19/health/19drug.html?_r=1
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Pfizer Recalls Select Lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg
Pfizer Pharmaceuticals LLC has recalled select lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg, and Nitrostat (Nitroglycerin) Tablets, 0.6mg. The following lot numbers have been recalled because a bottle of Nitrostat 0.6 mg tablet was found in a carton that was suppose to contain Nitrostat 0.4 mg tablet:
1) Nitrostat (Nitroglycerin) Tablets, 0.4mg – Lot number V100670
2) Nitrostat (Nitroglycerin) Tablets, 0.6mg – Lot number V100546
Nitrostat contains the active ingredient nitroglycerin and is commonly used in the treatment of chest pain. Nitroglycerin is also sold under other brand names. This recall alert only applies to the select lot of Nitrostat 0.4mg and 0.6mg tablets. No other nitroglycerin products were involved in this recall.
To view the FDA notice about this recall, please visit:
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm262090.htm
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