miércoles, 15 de julio de 2015

FDA MedWatch - June 2015 Safety Labeling Changes includes 30 products with revisions to Prescribing Information

Safety Information > June 2015

MedWatch logo

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch June 2015 Safety Labeling Changes posting includes 30 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS sections:
Angeliq (drospirenone and estradiol) Tablets
Banzel (rufinamide) Oral Tablets and Oral Suspension
Beyaz (drospirenone/ethinylestradiol/levomefolate calcium) Tablets 
Capoten (captopril) Tablets
Cardura XL (doxazosin mesylate extended release tablets) 
Doryx (doxycycline delayed release) Tablets 
Enjuvia (synthetic conjugated estrogens, B) Tablets 
Hycamtin (Topotecan) Injection
Jevtana (cabazitaxel) Injection
Keytruda (pembrolizumab) Injection 
Nexium 24HR (esomeprazole magnesium) Delayed-release Capsules (OTC) 
Omeprazole Delayed Release Tablets (OTC) 
Prevacid 24HR (lansoprazole) Delayed Release Capsules (OTC) 
Rocephin (ceftriaxone sodium) for Injection 
Safyral (drospirenone/ethinylestradiol/levomefolate calcium) Tablets  
Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets
Xeljanz (tofacitinib) Tablets 
Xgeva (denosumab) 
Yasmin (drospirenone/ethinylestradiol) Tablets 
Yaz (drospirenone/ethinylestradiol) Tablets
Zegerid (omeprazole, 20 mg and sodium bicarbonate, 1100mg) Capsules (OTC)
Zometa (zoledronic acid) Injection

No hay comentarios:

Publicar un comentario