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
Lenvima (lenvatinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hypertension
In Study 2 in RCC, hypertension was reported in 42% of patients in the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Inspra (eplerenone)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hyperkalemia
The risk of hyperkalemia is higher in patients with impaired renal function,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Invokana (canagliflozin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Acute Kidney Injury and Impairment in Renal Function
INVOKANA causes intravascular volume... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Habitrol (nicotine transdermal system) Patch
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS and PATIENT PACKAGE INSERT
Ask a doctor before use if you have (add the following two bullets to this section)
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Faslodex (fulvestrant)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Immunoassay Measurement of Serum Estradiol
Due to structural similarity of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
EpiPen and EpiPen Jr. (epinephrine injection) 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
Epinephrine Injection, USP (epinephrine, 1:1000)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Serious Infections at the Injection Site
Rare cases of serious skin and soft tissue... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Doryx (doxycycline hyclate delayed-release tablets)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Tooth Development
Use Doxycycline Hyclate Delayed- Release Tablets in pediatric patients 8... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cotellic (cobimetinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hepatic Impairment (update)
Adjustment in the starting dose of COTELLIC is not required in... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cometriq (cabozantinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of action, COMETRIQ... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
