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Home › Posts tagged Dabigatran [Pradaxa]

Tag: Dabigatran [Pradaxa]

Direct Oral Anticoagulants (DOAC): Newly Identified Genes and Genetic Variants

By Joseph Gut - thasso Posted on January 26, 2019 Posted in Drug/Drug Interaction, Genetic Background, New Research, Pharmacogenetics, Thasso Post, Theragenomic Medicine Tagged with ABCB1 Gene, Apixaban (Eliquis), CES1 Gene, CYP2C9 Gene, CYP3A4 Gene, Dabigatran [Pradaxa], Direct Oral Anticoagulants (DOAC), Drug-Drug Interaction, Edoxaban (Savaysa), Factor Xa Gene, Genetic Locus, Genetic Variants, Idarucizumab (Praxbind), P-glycoprotein, Rivaroxaban (Xarelto), Single-Nucleotide Polymorphism (SNP), SLCOB1 Gene, Thasso Post, Theragenomic Medicine, VKORC1 Gene

Direct Oral Anticoagulants (DOAC): Newly Identified Genes and Genetic Variants

January 26, 2019 – Pharmacogenomic approaches are increasingly revealing newly identified genes and genetic variants that are at the base of remarkable inter-individual pharmacokinetic and pharmacodynamic variation of novel direct oral anticoagulants (DOAC). Lately, DOACs have shown an upward prescribing trend due …

Direct Oral Anticoagulants (DOAC): Newly Identified Genes and Genetic Variants Read more »

Idarucizumab (Praxbind): Antidote for Dabigatran (Pradaxa) approved by FDA and recommended for approval by EMA

By Joseph Gut - thasso Posted on December 16, 2015 Posted in New Drug Approval, Thasso Post, Theragenomic Medicine Tagged with Anticoagulant, Antidote, Dabigatran [Pradaxa], Idarucizumab (Praxbind), Thasso Post, Theragenomic Medicine

Idarucizumab (Praxbind): Antidote for Dabigatran (Pradaxa) approved by FDA and recommended for approval by EMA

December 16, 2015 – This post is somewhat delayed; however, it may still be of interest for some readers of thasso post and therefore, the information is provided here uncommented, as it was issued by both the FDA and the EMA …

Idarucizumab (Praxbind): Antidote for Dabigatran (Pradaxa) approved by FDA and recommended for approval by EMA Read more »

Dabigatran (Pradaxa) Drug Safety Communication: Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

By Joseph Gut - thasso Posted on May 14, 2014 Posted in Adverse Drug Reaction [ADR], Thasso Post Tagged with American Food & Drug Administration (FDA), Anticoagulation, Bleeding (Brain), Bleeding (Major; Gastointestinal), Dabigatran [Pradaxa], Non-Valvular Atrial Fibrillation (AF), Post Marketing Data, Stroke (Clot-Related), Stroke (Ischemic)

May 13, 2014 – The Pradaxa story continues. See the latest MedWatch Drug Safety Communication, posted on 05/13/2014. ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding …

Dabigatran (Pradaxa) Drug Safety Communication: Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin Read more »

Dabigatran [Pradaxa]: Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events

By Joseph Gut - thasso Posted on December 13, 2011 Posted in Adverse Drug Reaction [ADR] Tagged with Anticoagulant, Bleeding, Dabigatran [Pradaxa]

December 12, 2011 – This is from a press release from December 07, 2011: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes …

Dabigatran [Pradaxa]: Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events Read more »

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FDA press releases

FDA Roundup: March 21, 2023 March 21, 2023
FDA Roundup: March 17, 2023 March 17, 2023
FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products March 17, 2023
FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product March 16, 2023
Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age March 14, 2023

FDA MedWatch

Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity March 22, 2023
UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication March 22, 2023
2023 Safety Communications March 22, 2023
2023 Medical Device Recalls March 17, 2023
Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure March 17, 2023

EMA Press releases

Advancing regulatory science in the EU – mid-point report published, , 22/03/2023 March 22, 2023
EMA Management Board: highlights of March 2023 meeting, MB, 17/03/2023 March 17, 2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023, PRAC, 17/03/2023 March 17, 2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022, CVMP, 09/12/2022 March 15, 2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023, CVMP, 17/02/2023 March 10, 2023

random genetics

How misplaced DNA could influence disease risk March 23, 2023
DNA is our body's instruction manual. It contains all the information that our cells need to make proteins and other molecules vital for our development, growth and survival.
New insights into the origins of spinal muscular atrophy March 22, 2023
Columbia researchers have discovered how a genetic defect leads to spinal muscular atrophy (SMA), a critical piece of information about the disease that neurologists have been seeking for decades.
Enabling adeno-associated virus gene therapy despite preexisting humoral immunity March 22, 2023
The use of a monoclonal antibody that reduced circulating IgG levels, led to a decrease in preexisting neutralizing antibodies (NAbs) to adeno-associated virus (AAV). The study, which showed that this strategy enabled gene delivery to the liver and heart via systemic AAV-based gene therapy in mice and non-human primates, is published in Human Gene Therapy.
From mutation to arrhythmia: Desmosomal protein breakdown as an underlying mechanism of cardiac disease March 22, 2023
Mutations in genes that form the desmosome are the most common cause of the cardiac disease arrhythmogenic cardiomyopathy (ACM), which affects one in 2,000 to 5,000 people worldwide. Researchers from the group of Eva van Rooij now discovered how a mutation in the desmosomal gene plakophilin-2 leads to ACM. They found that the structural and […]
New study reveals shared genetic markers underlying substance use disorders March 22, 2023
By combing through genomic data of over 1 million people, scientists have identified genes commonly inherited across addiction disorders, regardless of the substance being used. This dataset—one of the largest of its kind—may help reveal new treatment targets across multiple substance use disorders, including for people diagnosed with more than one.

Recent Comments

Joseph Gut - thasso on Is there pre-emptive genotyping to avoid adverse drug effects (ADRs)?: “Just testing. https://www.alphamannosidosis.com/en/for-patients-caregivers/disease-information/?utm_source=google&utm_medium=cpc&utm_campaign=AlphamannSearch_Paziente2020&gclid=EAIaIQobChMI2Pv7wNaC_AIVWud3Ch1J8AMPEAAYAiAAEgJGI_D_BwE/” Dec 18, 08:50
Joseph Gut - thasso on Including Africa in the research on rare genetic diseases: A must!: “The genetic diversity of African populations with respect to rare genetic diseases will help to better understand the mechanisms behind…” Dec 18, 04:09
Joseph Gut - thasso on The sixth sense: Are there genes associated with it?: “Does this now work as intended?” Dec 18, 03:55
David Walliams on Is genetic testing of value for ALS patients?: “CURED FROM GENITAL HERPES More than 5 years ago I was in pain with this deadly herpes virus, A few…” Nov 7, 16:08
Raul Malkovic on Is genetic testing of value for ALS patients?: “HOW MY WIFE GOT CURED FROM ALS Below is how i got a cure for my wife who suffered from Amyotrophic Lateral Sclerosis…” Nov 6, 21:18

Tag Cloud

Adverse Drug Reaction (ADR) African American Allelic Variant Allelic Variants American Food & Drug Administration (FDA) American Food & Drug Administration (FDA) Boxed Warning Breast Cancer Canagliflozin (Invokana) Cancer Children Committee for Medicinal Products for Human Use (CHMP) Companion Test Covid-19 Disease Diabetes Drug Induced Liver Injury (DILI) Epidermal Growth Factor Receptor (EGFR) Ethnicity European Medicine Agency (EMA) European Medicines Agency (EMA) Food and Drug Administration (FDA) Gene Therapy Genetic Background Genetic Predisposition Genetic Testing Genotype Health Canada Non-Small Cell Lung Cancer (NSCLC) Pembrolizumab [Keytruda] Personalized Medicine Phenotype Progressive Multifocal Leukoencephalopathy (PML) Rare Disease Risk Evaluation and Mitigation Strategy (REMS) SARS-CoV-2 Schizophrenia Sildenafil [Viagra] Stevens Johnson Syndrome [SJS] Targeted Therapy ThassoBase Thasso Post Theragenomic Medicine Toxic Epidermal Necrolysis (TEN) Type 2 Diabetes Vemurafenib [Zelboraf]

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