Sprix (ketorolac)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
New safety information pertaining to the risks of Cardiovascular Thrombotic Events, Heart Failure and Edema. In addition, some... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Solaraze (diclofenac sodium)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
New safety information pertaining to the risks of Cardiovascular Thrombotic Events, Heart Failure and Edema. In addition, some... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Potiga (ezogabine)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
BOXED WARNING
damage to the photoreceptors and vision loss… Macular abnormalities characterized as vitelliform lesions... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Ponstel (mefenamic acid)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
New safety information pertaining to the risks of Cardiovascular Thrombotic Events, Heart Failure and Edema. In addition, some... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zithromax (azithromycin) Zithromax IV (azithromycin for injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hypersensitivity
Fatalities have been reported. Cases of Drug Reaction with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zelboraf (vemurafenib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Radiation Sensitization and Radiation Recall
subsequent to vemurafenib treatment.. Fatal cases... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zarontin (ethosuximide)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS
Serious Dermatologic Reactions
Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS), have... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xarelto (rivaroxaban)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Risk of Bleeding
Addition of selective serotonin reuptake inhibitors, and serotonin... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tysabri (natalizumab)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Progressive Multifocal Leukoencephalopathy (addition)
MRI findings may be apparent before... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Twinject, Adrenaclick & Epinehrine Injection USP Auto-Injector
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Injection-Related Complications
Hold leg firmly during injection.
Lacerations, bent... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Teflaro (ceftaroline fosamil)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS & PRECAUTIONS
Direct Coombs’ Test Seroconversion
Seroconversion from a negative to a positive direct... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Sterile Water for Injection, USP
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS
Hemolysis may occur following infusion of Sterile Water for Injection, USP. Hemoglobin induced renal failure... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Orkambi (lumacaftor/ivacaftor)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Effect on Blood Pressure
Increased blood pressure has been observed in some patients... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Opdivo (nivolumab)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
The following sections all include extensive updates, please refer to label:
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lithobid (lithium carbonate USP)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS
Lithium Toxicity (addition of paragraph)
The risk of lithium toxicity is increased in patients... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
