Atacand HCT (candesartan cilexetil/hydrochlorothiazide)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
PRECAUTIONS
Drug Interactions
Interactions with Candesartan Cilexetil
Coadministration of ATACAND HCT with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tecfidera (dimethyl fumarate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS (Revisions)
Progressive Multifocal Leukoencephalopathy
Progressive multifocal... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 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
Cimzia (certolizumab pegol) Lyophilized Powder and Solution for Subcutaneous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS
Risk of Serious Infections
Tuberculosis
Treatment of latent tuberculosis infection... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Fluorescite (fluorescein injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
CONTRAINDICATIONS
Hypersensitivity
FLUORESCITE® Injection 10% is contraindicated in patients with known... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 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)
February 2016
ADVERSE REACTIONS
DRUG INTERACTIONS
Hepatitis C Antiviral Agents
Coadministration of tenofovir... (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
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Postmarketing
Weight increased
DRUG INTERACTIONS
Hepatitis C Antiviral Agents:
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Vistaril (hydroxyzine pamoate) Capsules and Oral Suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –
February 2016
CONTRAINDICATIONS
Hydroxyzine is contraindicated in patients with a prolonged QT interval.
PRECAUTIONS
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Breo Ellipta (fluticasone furoate/vilanterol) Inhalation Powder
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Post-Marketing Experience
Musculoskeletal and Connective Tissue Disorders
Muscle Spasms
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
DRUG INTERACTIONS
NS5A inhibitor/NS5B polymerase inhibitor: ledipasvir/sofosbuvir
Patients receiving ATRIPLA and... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 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
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
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
