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Home › Posts tagged Drug Safety Communication

Tag: Drug Safety Communication

Umbralisib (Ukoniq): Drug recall because increased risk of patient death

By Joseph Gut - thasso Posted on May 8, 2022 Posted in Adverse Drug Reaction [ADR], Market Withdrawal, Regulatory Announcement, Thasso Post, Theragenomic Medicine 1 Comment Tagged with Breaktrough Therapy, Drug Safety Communication, Follicular Lymphoma (FL), Increased Risk Of Death, Market Withdrawal, Orphan Drug Designation, Priority Review, Safety Signal, Splenic Marginal Zone Lymphoma (MZL), Thasso Post, Theragenomic Medicine, Umbralisib (Ukoniq), Voluntary Withdrawal

Umbralisib (Ukoniq): Drug recall because increased risk of patient death

May 08, 2022 – Umbralisib (Ukoniq) is a medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). Umbralisib (Ukoniq) inhibits multiple kinases. In biochemical and cell-based assays, Umbralisib inhibited PI3Kδ and casein kinase CK1ε. PI3Kδ is expressed in …

Umbralisib (Ukoniq): Drug recall because increased risk of patient death Read more »

Is there a heightened risk of heart failure with diabetes medications containing saxagliptin and alogliptin?

By Joseph Gut - thasso Posted on April 6, 2016 Posted in Adverse Drug Reaction [ADR], New Safety Information, Thasso Post, Theragenomic Medicine No Comments Tagged with Alogliptin (Nesina), Alogliptin/Metformin (Kazano), Alogliptin/Pioglitazone (Oseni), American Food & Drug Administration (FDA), Diabetes, Drug Safety Communication, Heart Failure, Saxagliptin [Onglyza], Saxagliptin/Metformin (Kombiglyze XR), Thasso Post, Theragenomic Medicine

Is there a heightened risk of heart failure with diabetes medications containing saxagliptin and alogliptin?

April o5, 2016 – There have been indications that a heightened risk of heart failure may be associated with diabetes medications containing the pharmacologically active ingredients saxagliptin or alogliptin. In the US, this includes the FDA-approved drugs Saxagliptin (Onglyza), Saxagliptin/Metformin …

Is there a heightened risk of heart failure with diabetes medications containing saxagliptin and alogliptin? Read more »

Drug Safety Communication: DPP-4 inhibitors for Type 2-Diabetes may cause severe joint pain

By Joseph Gut - thasso Posted on August 29, 2015 Posted in Adverse Drug Reaction [ADR], Thasso Post, Theragenomic Medicine No Comments Tagged with DPP-4 Inhibitor, Drug Safety Communication, MedWatch, Severe Joint Pain, Thasso Post, Theragenomic Medicine, Type 2 Diabetes

Drug Safety Communication: DPP-4 inhibitors for Type 2-Diabetes may cause severe joint pain

August 29, 2015 – This may after all not be so good news for Type 2-Diabetes patients on DPP-4 inhibitor medications. The American Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines containing the pharmacologically active …

Drug Safety Communication: DPP-4 inhibitors for Type 2-Diabetes may cause severe joint pain Read more »

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FDA press releases

FDA, Veterans Health Administration Collaborate to Help Accelerate Medical Device Innovation and Advancement of Care September 28, 2022
FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease September 28, 2022
FDA Roundup: September 27, 2022 September 27, 2022
Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types September 27, 2022
FDA Roundup: September 23, 2022 September 23, 2022

FDA MedWatch

Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil September 28, 2022
Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter September 27, 2022
Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern September 23, 2022
2022 Medical Device Recalls September 23, 2022
Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication September 23, 2022

EMA Press releases

New co-chairs elected for working parties for healthcare professionals and for patients and consumers, , 23/09/2022 September 23, 2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022, CHMP, 16/09/2022 September 19, 2022
Biosimilar medicines can be interchanged, CHMP, 19/09/2022 September 19, 2022
New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection , CHMP, 16/09/2022 September 16, 2022
EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines, CHMP, 16/09/2022 September 16, 2022

random genetics

Study identifies how cancer-causing gene regulates genetic variation in prostate cancer September 27, 2022
Researchers from Barts Cancer Institute (BCI) at Queen Mary University of London, the Italian Institute for Genomic Medicine, and the University of Milan have identified a novel role for a cancer-causing gene in controlling an important genetic process that underpins genetic variation in prostate cancer.
Genetic tests create treatment opportunities and confusion for breast cancer patients September 27, 2022
The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment.
Call to convert mental health genetic discoveries into better treatments for patients September 27, 2022
QIMR Berghofer scientists are challenging the research and funding community to develop better treatments for debilitating mental health conditions by tapping the many extraordinary genetic discoveries made over the last decade to deliver a new era of precision psychiatry.
A predictive biomarker of response to therapy in patients with microsatellite stable metastatic colorectal cancer September 27, 2022
Results of a study led by VHIO investigators and published in Nature Medicine have unmasked mutations in the RNF43 gene as predictive biomarkers of response to treatment with anti-BRAF/EGFR combinatory therapy in patients with microsatellite stable BRAF V600E metastatic colorectal cancer (MSS mCRC). Data show that patients with tumors harboring loss-of-function mutations in RNF43 respond […]
Diagnosis of genetic cause in motor neuron disease patients could be missed due to age limits on genetic testing September 26, 2022
Based on the findings of a new study published in Brain, researchers from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London are calling for a complete rethink of the national guidelines surrounding who can access genetic testing for amyotrophic lateral sclerosis (ALS), also called motor neuron disease. The research suggests that […]

Recent Comments

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thassodotcom on Unlucky women with BIA-ALCL: An update: “The Therapeutic Goods Agency (TGA) of Australia has just issued a hazard alert concerning the risk of breast implant-associated anaplastic…” Aug 4, 09:17
thassodotcom on Tofacitinib (Xeljanz): Dangers of blood clots in the lungs and of death: “According to its Drug Safety Communication from 07/26/2019, the FDA has approved new warnings about an increased risk of blood…” Aug 4, 08:40

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 Clinical Trial Committee for Medicinal Products for Human Use (CHMP) Companion Test Covid-19 Covid-19 Disease Diabetes Drug Induced Liver Injury (DILI) Epidermal Growth Factor Receptor (EGFR) Erectile Dysfunction Ethnicity European Medicines Agency (EMA) Food and Drug Administration (FDA) Gene Therapy Genetic Background Genetic Predisposition Genetic Testing Health Canada Non-Small Cell Lung Cancer (NSCLC) Obesity Pembrolizumab [Keytruda] Personalized Medicine Progressive Multifocal Leukoencephalopathy (PML) Rare Disease Risk Evaluation and Mitigation Strategy (REMS) SARS-CoV-2 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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thasso, the new generation glocalized patient network in theragenomic and personalized medicine and individualized drug safety provides access to and sharing of personal and professional information in health and disease to individual patients, to patient subgroups, and to large patient populations worldwide

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Social Media, Social Network, Theragenomic Medicine, Social Medicine, Personalized Medicine, Genomic Medicine, Participative Medicine, Targeted Therapy, Individualized Therapy, Personalized Therapy, Individualized Drug Safety, Personalized Drug Safety, Genetic Variants, Allelic Variants, Genotypes, Molecular Phenotypes, Clinical Phenotypes, Companion Test, Heart Disease, Arthritis, Asthma, Diabetes, Hypertension, Malignant Tumors, Breast Cancer, Lung Cancer, Skin Cancer, Erectile Dysfunction, Crowd Sourcing, Patient Sourcing, Participative Sourcing, Collective Experience, Collective Community Wisdom, Apomediary Patient Expert, Patient Cloud,

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