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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:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm453965.htm
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
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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