Nitromist (nitroglycerin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
CONTRAINDICATIONS
PDE5 Inhibitor Use
Addition to the end of the paragaragh: Do not use NitroMist in patients who... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Hectorol (doxercalciferol)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
CONTRAINDICATIONS
(addition) Hectorol Injection is contraindicated in patients with previous hypersensitivity to... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Farxiga (dapagliflozin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
CONTRAINDICATIONS
Update phrase end-stage renal disease (ESRD) to (eGFR less than 30 mL/min/1.73 m2) end-stage renal... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Aubagio (teriflunomide)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
CONTRAINDICATIONS
(addition) Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xigduo XR (dapagliflozin and metformin HCl extended-release)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
BOX WARNING (extensively updated, please refer to label)
WARNING: LACTIC ACIDOSIS
Postmarketing cases of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Sabril (vigabatrin) Tablet Sabril (vigabatrin) Oral Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
BOXED WARNING
Additional and updated bullets:
SABRIL can cause permanent bilateral concentric visual field... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Elitek (rasburicase)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
BOX WARNING
Change 1st section of Anaphylaxis to read:
Hypersensitivity Reactions: Elitek can cause serious and fatal... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tamiflu (oseltamivir phosphate) Capsules and Oral Suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Serious Skin/Hypersensitivity Reactions
(Addition of sentence to section)The use of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Imbruvica (ibrutinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Postmarketing Experience
(Addition) Respiratory disorders: interstitial lung disease (includes... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zithromax (azithromycin) Zithromax IV (azithromycin for injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Hypersensitivity
Fatalities have been reported. Cases of Drug Reaction with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zelboraf (vemurafenib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Radiation Sensitization and Radiation Recall
subsequent to vemurafenib treatment.. Fatal cases... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zarontin (ethosuximide)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS
Serious Dermatologic Reactions
Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS), have... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xarelto (rivaroxaban)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Risk of Bleeding
Addition of selective serotonin reuptake inhibitors, and serotonin... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tysabri (natalizumab)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
WARNINGS AND PRECAUTIONS
Progressive Multifocal Leukoencephalopathy (addition)
MRI findings may be apparent before... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Twinject, Adrenaclick & Epinehrine Injection USP 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
