March 2016 Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Drug Safety Labeling Changes The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information. Key to Label Section Acronyms: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE DRUG NAME SECTIONS MODIFIED (Click on drug name to go to detailed view) BW C W P AR PPI/MG Invega (paliperidone) Extended-Release Tablets*Contraindication: hypersensitivity X Invega Sustenna (paliperidone palmitate) Extended-release Injectable Suspension*Contraindication: hypersensitivity X Invega Trinza (paliperidone palmitate) Extended-release Injectable Suspension*Contraindication: hypersensitivity X Invokamet (canagliflozin and metformin hydrochloride) Tablets X X X X Invokana (canagliflozin) Tablets X X X X PLASMA-LYTE 56 and 5% Dextrose Injection X X Renagel (sevelamer hydrochloride) Tablets X X Renvela (sevelamer carbonate) Powder for Oral Suspension X X Risperdal (risperidone) Tablets, Oral Solution and Risperdal M-TAB (risperidone) Orally Disintegrating Tablets*Contraindication: hypersensitivity X Risperdal Consta (risperidone) Long Acting Injection*Contraindication: hypersensitivity X Tudorza Pressair (aclidinium bromide inhalation powder) X X X X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Adcetris (brentuximab vedotin) for Injection X X Angiomax (bivalirudin) Lyophilized Powder for Injection X X X Droxia (hydroxyurea) and Hydrea (hydroxyurea) Capsules X X X Faslodex (fulvestrant) Solution for Injection X X Herceptin (trastuzumab) Intravenous Infusion X X X Implanon (etonogestrel) Implant X X X Jakafi (ruxolitinib phosphate) Tablet X X Juxtapid (lomitapide) Capsules X X Nexplanon (etonogestrel) Implants X X X Oxytrol for Women (oxybutynin) Transdermal System X Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets X X Xgeva (denosumab, AMG 162; Human Monoclonal Antibody to RANK Ligand) X X X Zarxio (filgrastim-sndz) X X X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Furosemide Tablets, Injection and Lasix (furosemide) Tablets X Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Fixed-dose Combination Tablet X Klonopin (clonazepam) Tablets X Prezcobix (darunavir and cobicistat) Tablet X Sustiva (efavirenz) Capsules and Tablets X (Click on drug name to go to detailed view) BW C W P AR PPI/MG Cleocin HCl (clindamycin hydrochloride) Capsules X Cleocin Phosphate (clindamycin) Injection and (clindamycin injection in 5% dextrose) Solution in Galaxy Plastic Containers X Increlex (mecasermin [rDNA origin] injection) X Jetrea (ocriplasmin intravitreal) Injection X Zaltrap (ziv-aflibercept) Injection X Zometa (zoledronic acid) Injection X
