FDA MedWatch - June 2016 Safety Labeling Changes includes 42 products with revisions to Prescribing Information

Safety Information > June 2016

The MedWatch June 2016 Safety Labeling Changes posting includes 42 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/ucm509048.htm

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and/or PRECAUTIONS sections:

Elitek (rasburicase)
Afinitor (everolimus)
Aubagio (teriflunomide)
Avycaz (ceftazidime and avibactam)
Bendeka (bendamustine hydrochloride)
Cardura (doxazosin)
Cerebyx (fosphenytoin sodium)
Children's Motrin (ibuprofen)
Dilantin (phenytoin) Injection, Dilantin (phenytoin) Oral Suspension
Envarsus XR (tacrolimus extended release)
Farxiga (dapagliflozin)
Farydak (panobinostat)
Hectorol (doxercalciferol) 
Humira (adalimumab)
Iclusig (ponatinib hydrochloride) 
Kuvan (sapropterin dihydrochloride)
Lybrel (levonorgestrel and ethinyl estradiol)
Natpara (parathyroid hormone)
Nitromist (nitroglycerin)
Orfadin (nitisinone)
Pomalyst (pomalidomide)
Prezista (darunavir) Tablet and Oral Suspension
Sabril (vigabatrin) Oral Solution 
Sabril (vigabatrin) Tablet
Stivarga (regorafenib)
Tamiflu (oseltamivir phosphate) Capsules and Oral Suspension
Technivie (ombitasvir, paritaprevir and ritonavir) Tablets
Tivicay (dolutegravir)
Tybost (cobicistat)
Tyvaso (treprostinil)
Viekira PAK (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets)
Xigduo XR (dapagliflozin and metformin HCl extended-release)
Zosyn (piperacillin and tazobactam for injection) and Zosyn (piperacillin sodium and tazobactam sodium injection)