MedWatch
The MedWatch April 2012 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” accessible via the link below provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm The following drugs had modifications to [...]
Continue reading about FDA MedWatch – Safety Labeling Changes for April 2012
The MedWatch March 2012 Safety Labeling Changes posting includes 39 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” available via the link below provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm299284.htm The following drugs had modifications to the [...]
Continue reading about FDA MedWatch – 39 Products Safety Labeling Changes March 2012
The MedWatch February 2012 Safety Labeling Changes posting includes 65 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” available via the link below provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm294217.htm The following drugs had modifications [...]
Continue reading about FDA MedWatch – 65 Products Safety Labeling Changes Febrary 2012
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 enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added [...]
The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine’s active ingredient, bevacizumab, which my have resulted in patients [...]
Continue reading about FDA MedWatch – Avastin (bevacizumab): Counterfeit Product