Gilotrif (afatinib) Tablets, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Diarrhea
In Study 2, diarrhea occurred in 75% of patients treated with GILOTRIF... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cimzia (certolizumab pegol) for Injection, for Subcutaneous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
5.2 Malignancies
Melanoma and Merkel cell carcinoma have been reported in patients treated... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Betaseron (interferon beta-1b) for Injection, for Subcutaneous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Drug-induced Lupus Erythematosus
Cases of drug-induced lupus erythematosus have been... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Ringer’s Injection, USP in VIAFLEX Plastic Container
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
CONTRAINDICATIONS
Concomitant treatment with ceftriaxone and Ringer’s Injection, USP is contraindicated in... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lopid (gemfibrozil Tablets, USP)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
CONTRAINDICATIONS
combination therapy of gemfibrozil with dasabuvir
WARNINGS
…gemfibrozil is a... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Aciphex (rabeprazole sodium) Delayed-release Tablets, for Oral Use and Aciphex Sprinkle (rabeprazole sodium delayed-release capsules)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
CONTRAINDICATIONS
PPIs, including ACIPHEX, are contraindicated with rilpivirine-containing products.
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Kadcyla (ado-trastuzumab emtansine) for Injection, for Intravenous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
BOXED WARNING
Embryo-Fetal Toxicity: Exposure to KADCYLA during pregnancy can result in embryo-fetal harm. Advise... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Vibramycin (doxycycline hyclate) Intravenous
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
Summary View
WARNINGS
Use doxycycline in pediatric patients 8 years of age or less only when the potential... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Reclast (zoledronic acid) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Post-Marketing Experience
Osteonecrosis of other bones
Cases of osteonecrosis of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cordarone (amiodarone HCl) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS
Serious Symptomatic Bradycardia When Co-administered with Ledipasvir/Sofosbuvir or with Sofosbuvir with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
USE IN SPECIFIC POPULATIONS
Pregnancy
Animal data
Ombitasvir
Ombitasvir was administered orally to... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zestril (lisinopril) Tablets, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Zestril can cause fetal harm when administered to a pregnant... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Skyla (levonorgestrel-releasing intrauterine system)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Breast Cancer
Observational studies of the risk of breast cancer with use of a LNG-releasing... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Adcetris (brentuximab vedotin) for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Gastrointestinal Complications
Fatal and serious gastrointestinal (GI) complications... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Faslodex (fulvestrant) Solution for Injection
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 findings from animal studies and its mechanism of action,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
