Lenvima (lenvatinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hypertension
In Study 2 in RCC, hypertension was reported in 42% of patients in the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Inspra (eplerenone)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hyperkalemia
The risk of hyperkalemia is higher in patients with impaired renal function,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Invokana (canagliflozin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Acute Kidney Injury and Impairment in Renal Function
INVOKANA causes intravascular volume... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Habitrol (nicotine transdermal system) Patch
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS and PATIENT PACKAGE INSERT
Ask a doctor before use if you have (add the following two bullets to this section)
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Faslodex (fulvestrant)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Immunoassay Measurement of Serum Estradiol
Due to structural similarity of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
EpiPen and EpiPen Jr. (epinephrine injection) Auto-Injector
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Injection-Related Complications
Hold leg firmly during injection.
Lacerations, bent... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Epinephrine Injection, USP (epinephrine, 1:1000)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Serious Infections at the Injection Site
Rare cases of serious skin and soft tissue... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Doryx (doxycycline hyclate delayed-release tablets)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Tooth Development
Use Doxycycline Hyclate Delayed- Release Tablets in pediatric patients 8... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cotellic (cobimetinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hepatic Impairment (update)
Adjustment in the starting dose of COTELLIC is not required in... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cometriq (cabozantinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of action, COMETRIQ... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cefepime Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
ADD or other beta-lactams.
ADD Exercise caution… if this... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Caverject Impulse (alprostadil for injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Needle Breakage
Needle breakage, with a portion of the needle remaining in the penis, has been... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
AUVI-Q Autoinjector (epinephrine injection, USP)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
INJECTION-RELATED COMPLICATIONS
Do not inject into buttock. Additionally, injection into the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Adrenalin (epinephrine injection, USP)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Potential for Ophthalmic Injury from Adrenalin® 30 mL multiple-dose vial The Adrenalin® 30 mL... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Dobutamine in 5% Dextrose Injection, USP in Flexible Plastic Containers
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
CONTRAINDICATIONS
Add ... or any of its components.
PRECAUTIONS
General
Bold sentence: “During the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
