MedWatch
The US FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the […]
The MedWatch July 2011 Safety Labeling Changes posting includes 32 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. The “Summary Page” available via the following link provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm266122.htm Clicking on a […]
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The US FDA notified healthcare professionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. The study was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and […]
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The US FDA notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82 manufactured by Bracco Diagnostics, Inc. A CardioGen-82 PET scan is one of a variety of […]
The MedWatch June 2011 Safety Labeling Changes posting includes 50 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm261325.htm Clicking on a drug product name in the […]
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