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Category Archives: Cardiology
Elecsys Troponin I and STAT Immunoassays Recall
Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result AUDIENCE: Cardiology, Laboratory ISSUE: With certain types of plasma samples, doctors may receive a falsely low result (up to … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Laboratory
Tagged Cardiology, drug risks, Elecsys Troponin I, Elecsys Troponin I and STAT Immunoassays Recall, Laboratory, Recall, Roche Diagnostics Operations, STAT Immunoassays
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Thoratec Corporation HeartMate II Left Ventricular Assist System LVAS Class 1 Recall
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform Audience: Cardiology , Risk Manager, Transplant Issue: FDA is notifying health care professionals of a Class 1 Recall due to detachment of the … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Risk Manager
Tagged Cardiology, Class 1 Recall, Class I Recall, drug risks, FDA recall, HeartMate II LVAS, Left Ventricular Assist System LVAS, Recall, Risk Manager, Thoratec Corporation HeartMate II, Thoratec Corporation HeartMate II Left Ventricular Assist System LVAS Class 1 Recall, Transplant, Ventricular Assist System
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Celexa citalopram hydrobromide FDA Drug Safety Communication
Celexa (citalopram hydrobromide) – Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms AUDIENCE: Psychiatry, Cardiology ISSUE: FDA is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, FDA … Continue reading
Posted in Cardiology, FDA 2012, FDA Safety Communication, Psychiatry
Tagged Cardiology, Celexa, Celexa citalopram hydrobromide FDA Drug Safety Communication, citalopram hydrobromide, drug risks, Drug Safety Communication, FDA Drug Safety Communication, FDA notice, FDA warning, Potential Risk of Abnormal Heart Rhythms, Psychiatry, Revised Recommendations, safety label changes
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Automated External Defibrillators AEDs Class I Recall
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall – Defective Component Affected Models include: Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E CardioVive 92532, 92533 CardioLife 9200G and 9231 GE … Continue reading
Posted in Cardiology, Emergency Rooms, FDA 2012, FDA Recall, Risk Manager
Tagged AEDs, Automated External Defibrillators, Cardiac Science Powerheart, CardioLife, Cardiology, CardioVive, Class 1 Recall, Class I Recall, Defective Component, Emergency Medicine, FDA recall, GE Responder, Nihon-Kohden, Recall, Responder Pro
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Statin Drugs Drug Safety Communication Class Labeling Change
Statin Drugs – Drug Safety Communication: Class Labeling Change AUDIENCE: Cardiology, Family Practice, Patients ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver … Continue reading
Posted in Cardiology, Family Practice, FDA 2012, FDA Label Change, FDA Safety Communication
Tagged Advicor, Altoprev, Cardiology, cholesterol-lowering drugs, Class Labeling Change, Crestor, drug risks, Drug Safety Communication, Family Practice, FDA notice, labeling change, LDL, Lescol, Lipitor, Livalo, Mevacor, PRavachol, safety label changes, Simcor, Statin Drugs, Vytorin, Zocor
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Pradaxa (dabigatran etexilate mesylate) Drug Safety Communication
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events AUDIENCE: Cardiology, Pharmacy, Hematology ISSUE: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that … Continue reading
Posted in Cardiology, FDA 2011, FDA Notice, FDA Warning, Hematology, Pharmacy
Tagged Cardiology, dabigatran etexilate mesylate, drug risks, Drug Safety Communication, FDA notice, FDA warning, Hematology, Pharmacy, Pradaxa, Pradaxa (dabigatran etexilate mesylate) Drug Safety Communication
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Trilipix (fenofibric acid) Drug Safety Communication Label Change
Trilipix (fenofibric acid): Drug Safety Communication – Label Change AUDIENCE: Family Practice, Cardiology, Pharmacy ISSUE: FDA notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient’s risk of having a heart attack or stroke. FDA reviewed … Continue reading