Cleocin T (clindamycin phosphate) Solution, Lotion, and Gel, 1 Percent
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
addition of adverse events of eye pain and contact dermatitis
April 2014
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection for INTRAMUSCULAR USE ONLY
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
Postmarketing Experience
addition of pathological gambling and hiccups
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
DRUG INTERACTIONS
Established and Other Potential Drug Interactions
*update the Table 5 with patient... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Twynsta (telmisartan/amlodipine) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
Postmarketing Experience
Amlodipine
… Postmarketing reporting has also revealed a... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Trental (pentoxifylline) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
DRUG INTERACTIONS
Bleeding has been reported in patients treated with Trental with or without concomitant... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Hylenex recombinant (hyaluronidase human injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
DRUG INTERACTIONS
*addition of information on incompatibility between Hylenex recombinant (hyaluronidase... (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 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
Technivie (ombitasvir, paritaprevir, and ritonavir) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
DRUG INTERACTIONS
Established and Other Potential Drug Interactions
*update the Table 4 with patient... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Abilify Maintena (aripiprazole) for Extended-release Injectable Suspension, for Intramuscular Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
Postmarketing Experience
addition of pathological gambling and hiccups
... (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
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
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
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
