Oxaliplatin Injection for Intravenous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Severe Neutropenia
Grade 3 or 4 neutropenia occurred in 41 to 44% of patients with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Onglyza (saxagliptin) Tablets, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Pancreatitis
There have been postmarketing reports of acute pancreatitis in patients... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zonegran (zonisamide) Capsules, for Oral Administration
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Drug... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension, Vibramycin Hyclate (doxycycline hyclate capsules, USP), Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate tablets, USP)
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 benefits... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lenvima (lenvatinib) Capsules, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Hemorrhagic Events
Serious tumor related bleeds, including fatal hemorrhagic events... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Nesina (alogliptin) Tablets, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
Pancreatitis
Acute pancreatitis has been reported in the postmarketing setting and in... (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
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
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
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
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
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
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
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
Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications
FDA is warning about several safety issues with the class of opioid pain medicines, including serotonin syndrome, adrenal insufficiency, and androgen deficiency. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 22, 2016 Category: American Health Source Type: alerts
