Jetrea (ocriplasmin intravitreal) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
ADVERSE REACTIONS
Postmarketing Experience
Night blindness has been identified during post-approval use of Jetrea.... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Increlex (mecasermin [rDNA origin] injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
ADVERSE REACTIONS
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cleocin Phosphate (clindamycin) Injection and (clindamycin injection in 5% dextrose) Solution in Galaxy Plastic Containers
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
ADVERSE REACTIONS
An unpleasant or metallic taste has been reported after intravenous administration of the higher doses... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Prezcobix (darunavir and cobicistat) Tablet
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
DRUG INTERACTIONS
Potentially significant (Drug Interactions Table 2): Potentially Significant Drug Interactions:... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Klonopin (clonazepam) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
PRECAUTIONS
Respiratory Compromise: Klonopin should be used with caution in patients with compromised respiratory... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Fixed-dose Combination Tablet
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
DRUG INTERACTIONS
Table: Established and Other Potentially Significanta Drug Interactions: Alteration in Dose or... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Furosemide Tablets, Injection and Lasix (furosemide) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2012
ADVERSE REACTIONS
drug rash with eosinophilia and systemic symptoms
acute generalized exanthematous... (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
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
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
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
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
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
Tudorza Pressair (aclidinium bromide inhalation powder)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
CONTRAINDICATIONS
The use of TUDORZA PRESSAIR is contraindicated in the following conditions:
Severe hypersensitivity... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
