Oxytrol for Women (oxybutynin) Transdermal System
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
DRUG FACTS LABEL
The warnings section is now to read:
“Sleepiness, dizziness, confusion, and blurry vision... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Implanon (etonogestrel) Implant
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Complications of Insertion and Removal
There have been reports of migration of the implant... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Faslodex (fulvestrant) Solution for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Adcetris (brentuximab vedotin) for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Gastrointestinal Complications
Fatal and serious gastrointestinal (GI) complications... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zarxio (filgrastim-sndz)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Glomerulonephritis
Glomerulonephritis has occurred in patients receiving filgrastim... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xgeva (denosumab, AMG 162; Human Monoclonal Antibody to RANK Ligand)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Hypercalcemia Following Treatment Discontinuation in Patients with Growing Skeletons
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Jakafi (ruxolitinib phosphate) Tablet
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Risk of Infection
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Droxia (hydroxyurea) and Hydrea (hydroxyurea) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Based on the mechanism of action and findings in animals,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Nexplanon (etonogestrel) Implants
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Complications of Insertion and Removal
There have been reports of migration of the implant... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Herceptin (trastuzumab) Intravenous Infusion
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Verify the pregnancy status of females of reproductive potential prior... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Coadministration with Other Products
TRUVADA is a fixed-dose combination of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Angiomax (bivalirudin) Lyophilized Powder for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Acute Stent Thrombosis in Patients with STEMI undergoing PCI
Acute stent thrombosis... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Fosrenol (lanthanum carbonate) Chewable Tablets and Oral Powder
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS (Revisions)
Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Invirase (saquinavir mesylate) Capsules and Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS
QT Interval Prolongation
Patients initiating therapy with INVIRASE/ritonavir:
An ECG... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Avalide (irbesartan/hydrochlorothiazide) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS
Electrolyte and Metabolic Imbalances
Coadministration of AVALIDE with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
