Dulera (formoterol fumarate, mometasone furoate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
PLLR Conversion:
Pregnancy
Risk Summary
There are no randomized clinical studies... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Asmanex HFA (mometasone furoate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
PLLR Conversion:
Pregnancy
Risk Summary
There are no randomized clinical studies... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
CONTRAINDICATIONS
HICON is contraindicated in:
Patients with vomiting and diarrhea
Pregnancy
Lactation
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Expanded Recall Period of Certain Sunflower Kernel Products Due to Possible Contamination By Listeria Monocytogenes
TORONTO - As a precaution, SunOpta expanded its voluntary recall of a limited number of sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. (Source: FDA Food Safety)
Source: FDA Food Safety - May 19, 2016 Category: Food Science Source Type: alerts
Crestor (rosuvastatin calcium)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
May 2016
CONTRAINDICATIONS
Replace bullets 3 and 4 with the following:
Pregnancy
Lactation. Limited data indicate... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - May 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy
Danish study shows possible increased risk of miscarriage. FDA advises cautious prescribing of oral fluconazole in pregnancy, until more is understood about this study. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 26, 2016 Category: American Health 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
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
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
Siemens Healthcare Diagnostics, Inc - Dimension Vista LOCI Estradiol Test - Class 2 Recall
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2016 Category: Medical Equipment Source Type: alerts
Herceptin (trastuzumab) Intravenous Infusion
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Verify the pregnancy status of females of reproductive potential prior... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Biomerieux Inc - Granada Biphasic Broth - Class 2 Recall
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 30, 2015 Category: Medical Equipment Source Type: alerts
Philips Medical Systems, Inc. - Philips Avalon Monitors - Class 2 Recall
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 22, 2014 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens Healthcare CLINITEK Status Analyzer - Class 3 Recall
CLINITEK Status¿+ Analyzer (Urine chemistry analyzer) The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest¿ hCG tests. This analyzer is intended for the measurement of the following in urine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). These measurements are used to assist diagnosis in the follow...
Source: Medical Device Recalls - May 5, 2014 Category: Medical Equipment Source Type: alerts
