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RSS Channel: Rxmed - Labeling Changes
Rxmed labeling changes. Comprehensive drug news for both consumers and healthcare professionals.
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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...

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 ...

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 ...

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: ...

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...

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...

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...

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...

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...

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...

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...

Depakene (valproic acid) CapsulesDepakene (valproic acid) Oral Solution Depakote (divalproex sodium) Delayed Release TabletsDepakote Sprinkle CapsulesDepacon (valproate sodium) InjectionDepakote ER (divalproex sodium) Extended Release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) February 2016 ADVERSE REACTIONS Postmarketing Dermatologic: nail and nail bed disorders Metabolism and nutrition: weight...

Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) February 2016 DRUG INTERACTIONS Antipsychotics: quetiapine Initiation of STRIBILD in patients taking quetiapine: Consider...

Atacand (candesartan cilexetil) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) February 2016 WARNINGS AND PRECAUTIONS Hyperkalemia Concomitant use of ATACAND with drugs that may increase potassium levels may...

Anoro Ellipta (umeclidinium and vilanterol inhalation powder), for Oral Inhalation
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   February 2016 ADVERSE REACTIONS Postmarketing Experience In addition to adverse reactions reported from clinical trials,...

Effexor XR (venlafaxine Extended-Release) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) February 2016 ADVERSE REACTIONS Post-Marketing Experience Dyspnea interstitial lung disease   July 2014 ...

Simponi Aria (golimumab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) February 2016 ADVERSE REACTIONS Post-Marketing Experience Hypersensitivity Reactions In postmarketing experience, serious...

Zostavax (Zoster Vaccine, Live)
Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER)   February 2016 ADVERSE REACTIONS Postmarketing Eye Disorders: necrotizing retinitis (patients on...

Opsumit (macitentan) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) February 2016 ADVERSE REACTIONS Postmarketing General disorders and administration site conditions: edema/fluid retention ...

Gilenya (fingolimod) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   February 2016 CONTRAINDICATIONS Patients who have had a hypersensitivity reaction to fingolimod or any of the excipients...

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...

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 ...

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,...

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...

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 ...

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 ...

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...

Fanapt (iloperidone) Tablets  
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   January 2016 CONTRAINDICATIONS Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported ...

Orbactiv (oritavancin diphosphate) Lyophilized Powder for Injection 
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   January 2016 CONTRAINDICATIONS Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium...

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 ...

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...

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...

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...

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...

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. ...

Simponi Aria (golimumab) Injection, for Intravenous Infusion
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) February 2016 ADVERSE REACTIONS Post-Marketing Experience Hypersensitivity Reactions In postmarketing experience, serious...

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...

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...

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...

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...