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... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Simponi (golimumab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
WARNINGS AND PRECAUTIONS
Malignancies
Malignancies in Adult Patients
*section updated
Congestive Heart... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Ranexa (ranolazine) Extended-release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
Post Marketing Experience
Metabolism and Nutrition Disorders
Cases of hypoglycemia have been... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Orenitram (treprostinil) Extended Release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
Clinical Trials Experience
…The safety of Orenitram was also evaluated in an open-label... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
NeoProfen (ibuprofen lysine) Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
Post marketing Experience
*added term Pulmonary hypertension
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Mirapex ER (pramipexole) Extended-release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –
January 2016
ADVERSE REACTIONS
Postmarketing Experience
…skin reactions (including erythema, rash, pruritus,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Mirapex (pramipexole) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –
January 2016
ADVERSE REACTIONS
Postmarketing Experience
…skin reactions (including erythema, rash, pruritus,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
