Mavik (trandolapril) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS
Head and Neck Angioedema
Patients receiving coadministration of an ACE inhibitor with an mTOR (mammalian... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Kyprolis (carfilzomib) for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS AND PRECAUTIONS
Cardiac Toxicities
…These patients may be at greater risk for cardiac complications and... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Epaned (enalapril maleate) 1 mg/mL Powder (reconstituted) for Oral Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS
Angioedema and Anaphylactoid Reactions
Head and Neck Angioedema
…Patients receiving... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Halaven (eribulin mesylate) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS AND PRECAUTIONS
Neutropenia
*edits to this section
Peripheral Neuropathy
*edits to this... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Botox (onabotulinumtoxinA)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS AND PRECAUTIONS
Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Topotecan Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
BOXED WARNING
*Boxed warning updated to read:
WARNING: BONE MARROW SUPPRESSION
Topotecan injection can... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Gleostine (Lomustine) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
BOXED WARNING
* Boxed warning updated to read:
WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Propylthiouracil Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
BOXED WARNING
*updated
WARNING
Severe liver injury and acute liver failure, in some cases fatal,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Simponi Aria (golimumab) Injection, for Intravenous Infusion
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS AND PRECAUTIONS
Malignancies
Malignancies in Adult Patients
*section updated
Congestive Heart... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tarka (trandolapril/verapamil) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS
Head and Neck Angioedema
Patients receiving coadministration of an ACE inhibitor with an mTOR (mammalian... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Simponi (golimumab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS AND PRECAUTIONS
Malignancies
Malignancies in Adult Patients
*section updated
Congestive Heart... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lotronex (alosetron hydrochloride) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
BOXED WARNING
*Boxed warning updated to read:
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Miostat (carbachol intraocular solution, USP)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS
…The vial stopper contains natural rubber (latex) which may cause severe allergic reactions.
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tarka (trandolapril/verapamil) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS
Head and Neck Angioedema
Patients receiving coadministration of an ACE inhibitor with an mTOR (mammalian... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Iclusig (ponatinib) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Vascular Occlusion
Updates in graph
Arterial Occlusion and Thrombosis
Renal... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
