New Safety Information

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FDA safety communication concerning E-cigarettes

Posted on September 5, 2019 by by

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September 05, 2019 – An E-cigarette is a handheld battery-powered vaporizer that simulates smoking by providing some of the behavioral aspects of smoking, including the hand-to-mouth action of smoking, but without burning tobacco. Using an E-cigarette is known as “vaping” and the user is referred to as a “vaper.”

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Tags: Aerosol, Cannabinoid, Center for Disease Control and Prevention (CDC), E-Cigarette, E-Cigarette Legislation, E-Liquid, Tetrahydrocannabinol (THC), Thasso Post, Theragenomic Medicine, Tobacco Products Directive, Vaping, Vapor

Tofacitinib (Xeljanz): Dangers of blood clots in the lungs and of death

Posted on June 8, 2019 by by

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June 08, 2019 – For some time now, Tofacitinib (Xeljanz) receives intense attention in the media, with regulatory authorities, and patients and treating physicians alike because of serious concerns of increased risk of blood clots in the lungs and increased mortality in patients treated for ulcerative colitis at the 10-mg twice-daily dose of Tofacitinib (Xeljanz).

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Tags: Blood Clots in the Lungs, Bood Clotting, Death, Janus Kinase 1 (JAK1), Janus Kinase 3 (JAK 3), Psoriatic Arthritis, Pulmonary Embolism, Rheumatoid Arthritis, Thasso Post, Theragenomic Medicine, Tofacitinib (Xeljanz), Ulcerative Colitis

Lemtrada: Deleterious unwanted effects in some multiple sclerosis patients

Posted on April 19, 2019 by by

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19 April 2019 – Alemtuzumab (Lemtrada) is used in the treatment of multiple sclerosis (MS). Moreover, Alemtuzumab, under the Tradenames of Campt, MabCampath and Campt-1H is on the markets for the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL),

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Tags: Alemtuzumab, Alemtuzumab (Lemtrada), American Food & Drug Administration (FDA), Arterial Dissection, European Medicines Agency (EMA), Hemophagocytic Lymphohistiocytosis, Multiple Sclerosis (MS), Thasso Post, Theragenomics Medicine

Unlucky women with BIA-ALCL: An update

Posted on February 17, 2019 by by

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February 17, 2019 – The unfortunate recognition of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a very rare form of a T-cell lymphoma, gains more momentum by the day. This is actually very positive a development, because it helps women who are getting breast implants for whatever reasons to better known associated health risks,

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Tags: American Food & Drug Administration (FDA), Breast Implant, Health Canada, Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), National Agency for the Safety of Medicines and Health Products (ANSM), Thasso Post, Theragenomics Medicine

Is there breast implant-associated cancer (BIA-ALCL)?

Posted on January 9, 2019 by by

thassodotcom Posted in In The Press, New Safety Information, Rare Diseases, Regulatory Announcement, Thasso Post, Theragenomic Medicine No Comments ↓

January 09, 2019 – Women should be alerted: Is there a thing like breast implant associated cancer (BIA-ALCL)? Yes, there is. Not every woman with a breast implant will get it, however. In fact, BIA-ALCL seems to be a rather rare condition; unfortunately,

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Tags: Breast Implant Associated Cancer (BIA-ALCL), L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), Rare Disease, Thasso Post, Theragenomic Medicine

Cancer therapies: Immune checkpoint inhibitors may kill you

Posted on October 21, 2018 by by

thassodotcom Posted in Adverse Drug Reaction [ADR], New Research, New Safety Information, Thasso Post, Theragenomic Medicine No Comments ↓

October 21, 2018 – In a study published online September 13 in JAMA Oncology, the authors just reminded us of the fact that besides all hype about immune checkpoint inhibitors (ICIs) in the cancer therapy field,

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Tags: Autoimmunity, CTLA-4 Gene, Fatal Adverse Drug Reaction (FADR), Fatal Colitis, Fatal Hepatitis, Fatal Myocarditis, Fatal Neurological Events, Fatal Pneumonitis, French National Alliance for Life and Health Sciences (AVIESAN), Immune Checkpoint Inhibitors (ICI's), Immune-Related Adverse Drug Reactions (irADRs), Ipilimumab [Yervoy], Nivolumab (Opdivo), Pembrolizumab [Keytruda], Programmed Cell Death–1/Ligand-1 (PD-1/PD-L1), Remove term: Fatal Adverse Drug Reaction (FADR) Fatal Adverse Drug Reaction (fADR), Uppsala Monitoring Center (UMC), VigiBase, World Health Organization (WHO)

Diabetes: No end to SGLT2-inhibitor drugs side effects

Posted on September 1, 2018 by by

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01 September 2018 – The American Food and Drug Administration (FDA) is warning that cases of a very rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

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Tags: American Food & Drug Administration (FDA), Canagliflozin (Invokana), Canagliflozin/Metformin (Invokamet XR), Canagliflozin/Metformin (Invokamet), Dapagliflozin (Farxiga), Dapagliflozin / Metformin (Xigduo XR), Dapagliflozin/Saxagliptin (Qtern), Empagliflozin [Jardiance], Empagliflozin/Linagliptin (Glyxambi), Empagliflozin/Metformin (Synjardy XR), Empagliflozin/Metformin (Synjardy), Ertugliflozin (Steglatro), Ertugliflozin/Metformin (Segluromet), Ertugliflozin/Sitagliptin (Steglujan), Fournier's Gangrene, Necrotizing Fasciitis of the Perineum (NF), SGLT2 Inhibitor, Sodium-Glucose Cotransporter-2 (SGLT2), Thasso Post, Theragenomic Medicine

Neural tube defects with Dolutegravir-based HIV medications

Posted on May 21, 2018 by by

thassodotcom Posted in Adverse Drug Reaction [ADR], New Safety Information, Regulatory Announcement, Thasso Post, Theragenomic Medicine No Comments ↓

May 22, 2018 –The American Food and Drug Administration (FDA) just released a Safety Alert concerning serious neural tube defects that might arise in babies born to women who took HIV medications that contained the active ingredient Dolutegravir. Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord,

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Tags: American Food & Drug Administration (FDA), Dolutegravir, Human Immunodeficiency Virus (HIV), Juluca, Neural Tube Defects (NTDs), Safety Alert, Tivicay, Triumeq

Are there life-threatening health problems with Limbrel?

Posted on November 22, 2017 by by

thassodotcom Posted in Adverse Drug Reaction [ADR], New Safety Information, Regulatory Announcement, Thasso Post, Theragenomic Medicine No Comments ↓

November 22, 2017 – Limbrel (Flavocoxid) is a medical food. A medical food is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements,

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Tags: 5-LOX, American Food & Drug Administration (FDA), Baicalin, Catechin, Center for Food Safety and Applied Nutrition (CFSAN), COX-1, COX-2, Drug-induced Liver Toxicity (DILI), Flavonoid, Hypersensitivity Pneumonitis, Limbrel (Flavocoxid), Medical Food, NSAID, Osteoarthritis, Thasso Post, the Council for International Organizations of Medical Sciences (CIOMS), Theragenomic Medicine

Febuxostat (Uloric): Gout medication with increased risk for heart-related death?

Posted on November 19, 2017 by by

thassodotcom Posted in Adverse Drug Reaction [ADR], New Safety Information, Regulatory Announcement, Thasso Post, Theragenomic Medicine No Comments ↓

November 19, 2017 – Gout is a terrible condition for those affected. Gout is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot, and swollen joint. Pain typically comes on rapidly in less than twelve hours. The joint at the base of the big toe is affected in about half of cases.

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