viernes, 15 de abril de 2016

FDA MedWatch - March 2016 Drug Safety Labeling Changes - 35 products with revisions to Prescribing Information

Safety Information > March 2016

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch March 2016 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
The following drugs had modifications to the CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections:
Adcetris (brentuximab vedotin) for Injection
Angiomax (bivalirudin) Lyophilized Powder for Injection
Droxia (hydroxyurea) and Hydrea (hydroxyurea) Capsules
Faslodex (fulvestrant) Solution for Injection
Furosemide Tablets, Injection and  Lasix (furosemide) Tablets
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Fixed-dose Combination Tablet
Herceptin (trastuzumab) Intravenous Infusion
Implanon (etonogestrel) Implant
Invega (paliperidone) Extended-Release Tablets
Invega Sustenna (paliperidone palmitate) Extended-release Injectable Suspension
Invega Trinza (paliperidone palmitate) Extended-release Injectable Suspension
Invokamet (canagliflozin and metformin hydrochloride) Tablets
Invokana (canagliflozin) Tablets
Jakafi (ruxolitinib phosphate) Tablet
Juxtapid (lomitapide) Capsules
Klonopin (clonazepam) Tablets
Nexplanon (etonogestrel) Implants
Oxytrol for Women (oxybutynin) Transdermal System
PLASMA-LYTE 56 and 5% Dextrose Injection
Prezcobix (darunavir and cobicistat) Tablet
Renagel (sevelamer hydrochloride) Tablets
Renvela (sevelamer carbonate) Powder for Oral Suspension
Risperdal (risperidone) Tablets, Oral Solution and Risperdal M-TAB (risperidone) Orally Disintegrating Tablets
Risperdal Consta (risperidone) Long Acting Injection
Sustiva (efavirenz) Capsules and Tablets
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Tudorza Pressair (aclidinium bromide inhalation powder) 
Xgeva (denosumab, AMG 162; Human Monoclonal Antibody to RANK Ligand)
Zarxio (filgrastim-sndz)

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