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Pharmacogenomic Biomarkers & pharmacogenetic test to prevent adverse drug reaction

Table of Pharmacogenomic Biomarkers in Drug Labeling

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe:

    • Drug exposure and clinical response variability
    • Risk for adverse events
    • Genotype-specific dosing
    • Mechanisms of drug action
    • Polymorphic drug target and disposition genes

Contact Connie Dello Buono, representative at medxprime to avail of pharmacogenetic test to prevent adverse drug reaction 408-854-1883 motherhealth@gmail.com . We are connecting with doctors and medical sales rep to bring personalize medicine this 2015.

The table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Biomarkers in the table include are not limited to germline or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities.

This table does not include non-human genetic biomarkers (e.g., viral or bacterial) i.e., microbial variants that influence sensitivity to anti-invectives; biomarkers that are used solely for diagnostic purposes unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs (e.g., for genetic diseases). Therapeutic areas do not necessarily reflect the FDA review division.

Pharmacogenomic information can appear in different sections of the labeling. Relevant sections of the labeling with such information are noted in the last column of the table. For more information on the relevance of information in various parts of drug labeling (e.g. Indications and Usage, Dosage and Administration, Boxed Warning, etc.), please refer to the appropriate labeling guidance. For information on the FDA’s initiative to improve prescription drug labeling, visit the FDA/CDER Learn website.

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Pharmacogenomic Biomarkers in Drug Labeling

Drug Therapeutic Area* Biomarker† Referenced Subgroup Labeling Sections
Abacavir Infectious Diseases HLA-B HLA-B*5701 allele carriers Boxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
Ado-Trastuzumab Emtansine Oncology ERBB2 HER2 protein overexpression or gene amplification positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Afatinib Oncology EGFR EGFR exon 19 deletion or exon 21 substitution (L858R) mutation positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Amitriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Anastrozole Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Clinical Pharmacology, Clinical Studies
Aripiprazole Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Dosage and Administration
Arsenic Trioxide Oncology PML/RARA PML/RARα (t(15;17)) gene expression positive Boxed Warning, Clinical Pharmacology, Indications and Usage, Warnings
Atomoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Atorvastatin Endocrinology LDLR Homozygous familial hypercholesterolemia Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Azathioprine Rheumatology TPMT TPMT intermediate or poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
Boceprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
Bosutinib Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive Indications and Usage, Adverse Reactions, Clinical Studies
Brentuximab Vedotin Oncology TNFRSF8 CD30 positive Indications and Usage, Description, Clinical Pharmacology
Busulfan Oncology Ph Chromosome Ph Chromosome negative Clinical Studies
Capecitabine Oncology DPYD DPD deficient Contraindications, Warnings and Precautions, Patient Information
Carbamazepine (1) Neurology HLA-B HLA-B*1502 allele carriers Boxed Warning, Warnings and Precautions
Carbamazepine (2) Neurology HLA-A HLA-A*3101 allele carriers Boxed Warning, Warnings and Precautions
Carglumic Acid Metabolic Disorders NAGS N-acetylglutamate synthase deficient Indications and Usage, Warnings and Precautions, Special Populations, Clinical Pharmacology, Clinical Studies
Carisoprodol Rheumatology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Special Populations
Carvedilol Cardiology CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
Celecoxib Rheumatology CYP2C9 CYP2C9 poor metabolizers Dosage and Administration, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Cetuximab (1) Oncology EGFR EGFR protein expression positive Indications and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
Cetuximab (2) Oncology KRAS KRAS codon 12 and 13 mutation negative Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Cevimeline Dental CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Chloroquine Infectious Diseases G6PD G6PD deficient Precautions
Chlorpropamide Endocrinology G6PD G6PD deficient Precautions
Cisplatin Oncology TPMT TPMT intermediate or poor metabolizers Clinical Pharmacology, Warnings, Precautions
Citalopram (1) Psychiatry CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Warnings
Citalopram (2) Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Clobazam Neurology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Dosage and Administration, Use in Specific Populations
Clomipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Clopidogrel Cardiology CYP2C19 CYP2C19 intermediate or poor metabolizers Boxed Warning, Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Clozapine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
Codeine Anesthesiology CYP2D6 CYP2D6 ultra-rapid metabolizers Boxed Warnings, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology , Patient Counseling Information
Crizotinib Oncology ALK ALK gene rearrangement positive Indications and Usage, Dosage and Administration, Drug Interactions, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Dabrafenib (1) Oncology BRAF BRAF V600E mutation positive Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Dabrafenib (2) Oncology G6PD G6PD deficient Warnings and Precautions, Adverse Reactions, Patient Counseling Information
Dapsone (1) Dermatology G6PD G6PD deficient Indications and Usage, Precautions, Adverse Reactions, Patient Counseling Information
Dapsone (2) Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions, Overdosage
Dasatinib Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive; T315I mutation-positive Indications and Usage, Clinical Studies, Patient Counseling Information
Denileukin Diftitox Oncology IL2RA CD25 antigen positive Indications and Usage, Warnings and Precautions, Clinical Studies
Desipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Dexlansoprazole (1) Gastroenterology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Drug Interactions
Dexlansoprazole (2) Gastroenterology CYP1A2 CYP1A2 genotypes Clinical Pharmacology
Dextromethorphan and Quinidine Neurology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Warnings and Precautions, Drug Interactions
Diazepam Psychiatry CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Doxepin Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Drospirenone and Ethinyl Estradiol Neurology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Warnings and Precautions, Drug Interactions
Eltrombopag (1) Hematology F5 Factor V Leiden carriers Warnings and Precautions
Eltrombopag (2) Hematology SERPINC1 Antithrombin III deficient Warnings and Precautions
Erlotinib (1) Oncology EGFR EGFR protein expression positive Clinical Pharmacology
Erlotinib (2) Oncology EGFR EGFR exon 19 deletion or exon 21 substitution (L858R) positive Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Esomeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Everolimus (1) Oncology ERBB2 HER2 protein overexpression negative Indications and Usage, Boxed Warning, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Everolimus (2) Oncology ESR1 Estrogen receptor positive Clinical Pharmacology, Clinical Studies
Exemestane Oncology ESR1 Estrogen receptor positive Indications and Usage, Dosage and Administration, Clinical Studies, Clinical Pharmacology
Fluorouracil (1) Dermatology DPYD DPD deficient Contraindications, Warnings, Patient Information
Fluorouracil (2) Oncology DPYD DPD deficient Warnings
Fluoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Warnings, Precautions, Clinical Pharmacology
Flurbiprofen Rheumatology CYP2C9 CYP2C9 poor metabolizers Clinical Pharmacology, Special Populations
Fluvoxamine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Fulvestrant Oncology ESR1 Estrogen receptor positive Indications and Usage, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Galantamine Neurology CYP2D6 CYP2D6 poor metabolizers Special Populations
Glimepiride Endocrinology G6PD G6PD deficient Warning and Precautions
Glipizide Endocrinology G6PD G6PD deficient Precautions
Glyburide Endocrinology G6PD G6PD deficient Precautions
Ibritumomab Tiuxetan Oncology MS4A1 CD20 positive Indications and Usage, Clinical Pharmacology, Description
Iloperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Dosage and Administration, Drug Interactions, Specific Populations, Warnings and Precautions
Imatinib (1) Oncology KIT c-KIT D816V mutation negative Indications and Usage, Dosage and Administration Clinical Pharmacology, Clinical Studies
Imatinib (2) Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Imatinib (3) Oncology PDGFRB PDGFR gene rearrangement positive Indications and Usage, Dosage and Administration, Clincal Studies
Imatinib (4) Oncology FIP1L1/PDGFRA FIP1L1/PDGFRα fusion kinase (or CHIC2 deletion) positive Indications and Usage, Dosage and Administration, Clinical Studies
Imipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Indacaterol Pulmonary UGT1A1 UGT1A1*28 allele homozygotes Clinical Pharmacology
Irinotecan Oncology UGT1A1 UGT1A1*28 allele carriers Dosage and Administration, Warnings, Clinical Pharmacology
Isosorbide and Hydralazine Cardiology NAT1-2 Slow acetylators Clinical Pharmacology
Ivacaftor Pulmonary CFTR CFTR G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R mutation carriers Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Lansoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Lapatinib Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Clinical Pharmacology, Patient Counseling Information
Lenalidomide Hematology del (5q) Chromosome 5q deletion Boxed Warning, Indications and Usage, Clinical Studies, Patient Counseling
Letrozole Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Adverse Reactions, Clinical Studies, Clinical Pharmacology
Lomitapide Endocrinology LDLR Homozygous familial hypercholesterolemia Indication and Usage, Adverse Reactions, Clinical Studies
Mafenide Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
Maraviroc Infectious Diseases CCR5 CCR5 positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Mercaptopurine Oncology TPMT TPMT intermediate or poor metabolizers Dosage and Administration, Precautions, Adverse Reactions, Clinical Pharmacology
Methylene Blue Hematology G6PD G6PD deficient Precautions
Metoclopramide Gastroentrology CYB5R1-4 NADH cytochrome b5 reductase deficient Precautions
Metoprolol Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions, Clinical Pharmacology
Mipomersen Endocrinology LDLR Homozygous familial hypercholesterolemia Indication and Usage, Clinical Studies, Use in Specific Populations
Modafinil Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Mycophenolic Acid Transplantation HPRT1 HGPRT deficient Precautions
Nalidixic Acid Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions
Nefazodone Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Nilotinib (1) Oncology BCR/ABL1 Philadelphia chromosome (t(9 :22)) positive Indications and Usage, Patient Counseling Information
Nilotinib (2) Oncology UGT1A1 UGT1A1*28 allele homozygotes Warnings and Precautions, Clinical Pharmacology
Nitrofurantoin Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
Nortriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Obinutuzumab Oncology MS4A1 CD20 positive Indication and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
Ofatumumab Oncology MS4A1 CD20 positive Indications and Usage, Clinical Pharmacology
Omacetaxine Oncology BCR/ABL1 BCR-ABL T315I Clinical Pharmacology
Omeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions
Panitumumab (1) Oncology EGFR EGFR protein expression positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Panitumumab (2) Oncology KRAS KRAS codon 12 and 13 mutation negative Indications and Usage, Clinical Pharmacology, Clinical Studies
Pantoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Drug Interactions, Special Populations
Paroxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Drug Interactions
Pazopanib Oncology UGT1A1 (TA)7/(TA)7 genotype (UGT1A1*28/*28) Clinical Pharmacology, Warnings and Precautions
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid Gastroenterology G6PD G6PD deficient Warnings and Precautions
Peginterferon alfa-2b Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
Pegloticase Rheumatology G6PD G6PD deficient Contraindications, Patient Counseling Information
Perphenazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Drug Interactions
Pertuzumab Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies, Clinical Pharmacology
Phenytoin Neurology HLA-B HLA-B*1502 allele carriers Warnings
Pimozide Psychiatry CYP2D6 CYP2D6 poor metabolizers Warnings, Precautions, Contraindications, Dosage and Administration
Ponatinib Oncology BCR –ABL T315I BCR –ABL T315I mutation Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Prasugrel Cardiology CYP2C19 CYP2C19 poor metabolizers Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Pravastatin Endocrinology LDLR Homozygous familial hypercholesterolemia Clinical Studies, Use in Specific Populations
Primaquine Infectious Diseases G6PD G6PD deficient Warnings and Precautions, Adverse Reactions
Propafenone Cardiology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Propranolol Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions, Drug Interactions, Clinical Pharmacology
Protriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Quinidine Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions
Quinine Sulfate Infectious Diseases G6PD G6PD deficient Contraindications, Patient Counseling Information
Rabeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Rasburicase Oncology G6PD G6PD deficient Boxed Warning, Contraindications
Rifampin, Isoniazid, and Pyrazinamide Infectious Diseases NAT1-2 Slow inactivators Adverse Reactions, Clinical Pharmacology
Risperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
Rituximab Oncology MS4A1 CD20 positive Indication and Usage, Clinical Pharmacology, Description, Precautions
Rosuvastatin Endocrinology LDLR Homozygous familial hypercholesterolemia Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Simeprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical studies, Clinical Pharmacology
Sodium Nitrite Antidotal Therapy G6PD G6PD deficient Warnings and Precautions
Sofosbuvir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology, Clinical Studies
Succimer Hematology G6PD G6PD deficient Clinical Pharmacology
Sulfamethoxazole and Trimethoprim Infectious Diseases G6PD G6PD deficient Precautions
Tamoxifen (1) Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Precautions, Medication Guide
Tamoxifen (2) Oncology F5 Factor V Leiden carriers Warnings
Tamoxifen (3) Oncology F2 Prothrombin mutation G20210A positive Warnings
Telaprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
Terbinafine Infectious Diseases CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Tetrabenazine Neurology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings, Clinical Pharmacology
Thioguanine Oncology TPMT TPMT poor metabolizers Dosage and Administration, Precautions, Warnings
Thioridazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions, Warnings, Contraindications
Ticagrelor Cardiology CYP2C19 CYP2C19 poor metabolizers Clinical Studies
Tolterodine Genitourinary CYP2D6 CYP2D6 poor metabolizers Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Tositumomab Oncology MS4A1 CD20 antigen positive Indications and Usage, Clinical Pharmacology
Tramadol Analgesic CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Trametinib Oncology BRAF BRAF V600E/K mutation positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Trastuzumab Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Tretinoin Oncology PML/RARA PML/RARα (t(15;17)) gene expression positive Clinical Studies, Indications and Usage, Warnings
Trimipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Valproic Acid (1) Neurology POLG POLG mutation positive Boxed Warning, Contraindications, Warnings and Precautions
Valproic Acid (2) Neurology NAGS, CPS1, ASS1, OTC, ASL, ABL2 Urea cycle enzyme deficient Contraindications, Warnings and Precautions, Adverse Reactions, Medication Guide
Vemurafenib Oncology BRAF BRAF V600E mutation positive Indications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Venlafaxine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Voriconazole Infectious Diseases CYP2C19 CYP219 intermediate or poor metabolizers Clinical Pharmacology, Drug Interactions
Vortioxetine Neurology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Drug interactions, Clinical Pharmacology
Warfarin (1) Cardiology or Hematology CYP2C9 CYP2C9 intermediate or poor metabolizers Dosage and Administration, Drug Interactions, Clinical Pharmacology
Warfarin (2) Cardiology or Hematology VKORC1 VKORC1 rs9923231 A allele carriers Dosage and Administration, Clinical Pharmacology
Warfarin (3) Cardiology or Hematology PROC Protein C deficient Warning and precautions
Connie Dello Buono

Prevent vascular disease, manage inflammation, get GYV health caps to boost ATP cells performance and speedy repair of your body, email connie to get the caps and join in spreading the benefits with extra income for you at motherhealth@gmail.com and text 408-854-1883

How can we promote patient safety?

safety p2 safety

Source: http://www.jointcommission.org/

Patient safety in hospitals

Patient safety in hospitals and other settings are very important. I am sharing a letter to your doctor on the use of pharmacogenetic and toxicology tests to prevent adverse drug reactions on your future and curent medications. Email Connie Dello Buono ,rep at medxprime at motherhealth@gmail.com 408-854-1883 for a copy of the letter for your doctor. We are looking for doctors who want to add this ancillary service of pharmacogenetic tests to their practice and part time medical sales reps in the USA.

Branded, Generic and Personalized based on your genes, which one would you like?

meds tox each gene each metabolites enzymes alleles to determine metabolites pharmocogenetic test

If I need a medication, I wanted to avoid adverse drug reactions and that the drug/dosage is suited to my body based on my genetic makeup. Many more lives will be spared if we have personalized medicine.

Contact Connie 408-854-1883 , motherhealth@gmail.com  if you are a doctor or medical sales rep for more info on bringing personalized medicine to all.

Personalized pharmacogenetic tests for cardio drugs

Genomic technologies and Optimum Heart Care

The state of genomic knowledge of CVDs and stroke has expanded dramatically in recent years. Since our scientific statement was published in 2007, there has been rapid evolution of the genomic technologies, enabling a proliferation of GWASs investigating common, complex diseases, including CVDs and stroke. Because the number of associations that are tested within the GWAS platforms is large and most associations are weak, the process of conducting these studies has also evolved dramatically during this same period. Researchers from around the world have come together as collaborators both to replicate (to reduce the potential for type I errors) and to meta-analyze data (to have statistical power to identify weak effects).

We are on the precipice of further expansion to sequencing the whole genome of patients and large population cohorts to detect additional and rare variants predisposing to disease. Therefore, the next 5-year period will be consumed with mining the wealth of data that will be generated by this next phase of research. Additionally, progress in other “omics” fields will inform these sequence data to help in understanding function. Finally, the environment will be given more attention as we identify solutions to disease prevention and treatment.

We anticipate that in the near future we will determine genetically based disease susceptibility within individuals, families, and populations. We conclude this statement with recommendations intended to guide clinical and public health practice, to foster research, and to prepare both researchers and healthcare practitioners for the changes likely to occur as genetics are translated to the population and the clinical setting.

Currently Relevant Recommendations to Enable Future Discoveries and Optimization of Care

  • Continue to develop and implement research that accelerates the translation of genomic discoveries to the prevention and treatment of CVDs and stroke. We suggest including the following:

  • —Incentives for researchers to collect DNA and consent to use specimens and data in future studies

  • —Expansion of biorepositories linked to electronic health records

  • —Translational genomic research of all types, bidirectionally, from bench to population

  • —Support of multidisciplinary, collaborative research programs

  • —Support of expanded genetic counseling training opportunities

  • Continue these research agendas to follow up and use genetic discoveries:

  • —Characterize genes and genetic variants that are associated with CVD across individuals and populations from multiple ethnic groups both at population levels and in functional mechanistic studies

  • —Determine how environmental factors (including behaviors and drugs) interact with genetic variants to influence CVD

  • —Expand pharmacogenetic research to identify genetic variants that predict adverse drug reactions and better efficacy

  • —Develop new technologies in CVD characterization, risk assessment, and outcome prediction and test these technologies in randomized, controlled trials

  • Conduct implementation research to understand the clinical utility of genetic screening because this has not yet been systematically tested in the majority of cases. Prepare proactively for effective genetic screening programs:

  • —Establish prevalence and family history criteria that would trigger screening programs in at-risk populations

  • —Create standards and laboratory oversight mechanisms for genetic testing facilities

  • —Match appropriate treatment guidelines to particular genetic susceptibility findings

  • —Assess the potential cost-effectiveness of genetic screening programs

  • Educate our workforce:

  • —Train clinicians to understand genetic screening tests for complex CVDs and stroke and when to refer to a genetics clinic or engage a genetic counselor

  • —Include genetics in graduate educational curricula

  • —Educate researchers in genetics, computational biology, and statistical genetics

Source:

http://circ.ahajournals.org/content/129/25_suppl_2/S1/T4.expansion.html

2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults

  1. Focus on ASCVD Risk Reduction: 4 Statin Benefit Groups

    1. This guideline is based on a comprehensive set of data from RCTs from which 4 statin benefit groups were identified that focus efforts to reduce ASCVD events in secondary and primary prevention.

    2. This guideline identifies high-intensity and moderate-intensity statin therapy for use in secondary and primary prevention.

  2. A New Perspective on LDL-C and/or Non–HDL-C Treatment Goals

    1. The Expert Panel was unable to find RCT evidence to support continued use of specific LDL-C or non–HDL-C treatment targets.

    2. The appropriate intensity of statin therapy should be used to reduce ASCVD risk in those most likely to benefit.

    3. Nonstatin therapies, as compared with statin therapy, do not provide acceptable ASCVD risk-reduction benefits relative to their potential for adverse effects in the routine prevention of ASCVD.

  3. Global Risk Assessment for Primary Prevention

    1. This guideline recommends use of the new Pooled Cohort Equations to estimate 10-year ASCVD risk in both white and black men and women.

    2. By more accurately identifying higher-risk individuals for statin therapy, the guideline focuses statin therapy on those most likely to benefit.

    3. It also indicates, on the basis of RCT data, those high-risk groups that might not benefit.

    4. This guideline recommends a discussion between clinicians and patients before initiation of statin therapy.

  4. Safety Recommendations

    1. This guideline used RCTs to identify important safety considerations in individuals receiving treatment of blood cholesterol to reduce ASCVD risk.

    2. Using RCTs to determine statin adverse effects facilitates understanding of the net benefit from statin therapy.

    3. This guideline provides expert guidance on management of statin-associated adverse effects, including muscle symptoms.

  5. Role of Biomarkers and Noninvasive Tests

    1. Treatment decisions in selected individuals who are not included in the 4 statin benefit groups may be informed by other factors as recommended by the Risk Assessment Work Group and Blood Cholesterol Expert Panel.

  6. Future Updates to the Blood Cholesterol Guideline

    1. This is a comprehensive guideline for the evidence-based treatment of blood cholesterol to reduce ASCVD risk.

    2. Future updates will build on this foundation to provide expert guidance on the management of complex lipid disorders and incorporate refinements in risk stratification based on critical review of emerging data.

    3. RCTs comparing alternative treatment strategies are needed in order to inform future evidence-based guidelines for the optimum ASCVD risk-reduction approach.

Doctors and Med  Sales Rep needed to ensure personalize medicine to the public

Contact Connie Dello Buono, rep at medxprime.com and with our partner Toxicology and Pharmacogenetic tests lab based in California
408-854-1883 motherhealth@gmail.com

Will personalize medicine help cardio and pain doctors and their clients?

mental and behave panel casrdio panel cyp metabolizer types

Personalize medicine was one of the topics in recent speech of President Obama. Contact Connie Dello Buono 408-854-1883 motherhealth@gmail.com to avail of  this pharmacogenetic test lab services and tailor fit drugs admin to your clients to help reduce adverse drug reactions to many cardio and pain-med clients. We are also hiring for full time or part time med sales reps in the USA.

Join 25,000 people in helping redefine health with health concierge and precision medicine.

https://clubalthea.com/2016/10/14/your-complete-dna-sequence-will-help-shape-the-future-of-medicine/

Behave health panel

The Use of Genetics in Guiding Therapy from Mayo Clinic

http://www.mayomedicallaboratories.com/articles/hottopics/2012/06-pharm/index.html

In recent years, the Food and Drug Administration has introduced pharmacogenetic-related drug label warnings and precautions, including black box warnings, on some widely prescribed drugs in an effort to reduce adverse effects. Advances in the study of pharmacogenomics have resulted in development of tests to identify patients who would benefit from different treatment levels or the use of different drugs. Dr. Baudhuin provides an update of pharmacogenetics with a focus on drugs with FDA label warnings and precautions, the related pharmacogenetic tests available, and their use in the clinical setting.

Presenter:

Related Tests

Medxprime Jobs: Part time or Full time, medical sales rep in the USA to show doctors this pharmacogenetic drug tests, insurance covered. Contact Connie 408-854-1883 , motherhealth@gmail.com

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New Molecule Protects Heart from Toxic Breast Cancer Drugs

Enzyme phosphoinositide 3-kinase gamma

A new molecule has been found that protects the heart from toxic breast cancer drugs and also kills the cancerous tumour. The research from Italy addresses the burgeoning problem of heart disease in cancer survivors and is announced by the European Society of Cardiology (ESC).

Dr Alessandra Ghigo, first author and research fellow in the Department of Molecular Biotechnology and Health Sciences, University of Torino, Italy, said: “Cardiotoxicity of cancer drugs has become an increasing problem in the last decade due to the increasing success of anticancer therapy and aggressive use of these drugs. More people are now surviving cancer but it is estimated that 32% of them could die of heart disease caused by their treatment. This has led to a new field of medicine called cardio-oncology.”
Professor Patrizio Lancellotti, chair of the ESC EACVI/HFA Cardiac Oncology Toxicity Registry, said: “Patients with some forms of breast cancer are at greater risk of dying from heart disease than from cancer. A number of breast cancer treatments are toxic for the heart notably chemotherapy with anthracyclines, such as doxorubicin, or with trastuzumab (Herceptin). Radiation therapy can make anthracyclines even more cardiotoxic, as can the sequence of anthracylines followed by trastuzumab. The latter combination for metastatic breast cancer can cause severe heart failure in up to 27% of patients.”
The theme of World Cancer Day 2015 is ‘Not beyond us’. New research from Dr Ghigo presented for the first time at the Heart Failure Winter Research Meeting shows that solutions to cardiotoxicity of cancer drugs are within reach.

Inhibit activity of PI3Kɣ Enzyme

Dr. Ghigo’s research focuses on the enzyme phosphoinositide 3-kinase gamma (PI3Kɣ) which regulates heart function. She previously showed that inhibiting the activity of PI3Kɣ protected mice with hypertension from developing heart failure.
For the current study she used genetically modified mice expressing an inactive form of PI3Kɣ to mimic the use of an enzyme inhibitor. When the mice were treated with the anthracycline doxorubicin, they survived more than normal mice and their heart function was completely preserved. Normal mice, who had the active form of PI3Kɣ, developed severe heart failure within 2 months of beginning treatment with doxorubicin.

 Prevent heart failure after doxorubicin treatment

To see if the findings could be applied to humans the next step was to treat normal nice with doxorubicin plus a drug to inhibit the activity of PI3Kɣ. Dr Ghigo said: “The inhibitor was able to completely protect the mice from developing heart failure after doxorubicin treatment.”
The same experiment was then performed on mice with breast cancer to ensure that the PI3Kɣ inhibitor did not interfere with the anticancer activity of doxorubicin. Again the mice were treated with both doxorubicin and the PI3Kɣ inhibitor.
Dr. Ghigo said: “The PI3Kɣ inhibitor protected the mice from developing heart failure. Importantly, the inhibitor was able to synergise with the doxorubicin and help to delay tumour growth. This means we could use an inhibitor of PI3Kɣ to both protect the heart from doxorubicin and prevent tumour growth. Our research shows that inhibiting PI3Kɣ stops inflammation in the tumour and kills the tumour.”

Cardiotoxicity

She added: “One of the main problems with the cardiotoxicity induced by chemotherapy is that the anticancer regimens need to be modified. We may have to use lower doses of agents to prevent the cardiotoxicity or stop the treatment. By using this inhibitor of PI3Kɣ together with the chemotherapy we could allow a wider and safer use of anticancer therapies because we don’t need to lower the dose or change the treatment.”

Prevent heart failure caused by cancer

She concluded: “The mechanisms underlying heart failure induced by anticancer therapies are different to those underlying heart failure from other causes such as hypertension. For this reason there are no effective drugs on the market to prevent this new kind of heart failure. Our study shows that PI3Kɣ could be a novel way to prevent heart failure caused by cancer drugs while also helping to kill the tumour itself.”
Source: European Society of Cardiology (ESC)

Hiring Med Sales Reps for Pharmacogenomic test tool for Doctors

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Contact Connie Dello Buono 408-854-1883 motherhealth@gmail.com if you wanted to be a med sales rep to show this test tool to US doctors.  Doctors can use this genetic tests to personalize drugs based on each person genetic makeup. Now approved by insurance companies.

 

Pharmacogenetic test for patient safety, added value and income stream for doctors and to personalize medications

Pharmacogenetic testing (PGT) detects single nucleotide polymorphism of nine cytochrome P450 enzymes in the liver: CYP2D6, CYP2C9, CYP2C19, CYP3A4, CYP3A5, Factor II, Factor V, MTHFR, VKROC1.

By identifying the genotypes of these enzymes we can predict an individual’s ability to metabolize about 95% of all medications. The phenotypes are assigned based on the patients’ metabolizing ability as poor, intermediate, intermediate-extensive, extensive, and ultra-rapid metabolizers. Armed with the genetic information, physicians can provide personalized care by delivering the right medication at the right dosage to the right patient. In addition, PGT can help reduce adverse drug reactions, avoid drug interactions, prevent overdose and death, and save precious time and medical costs. Our lab’s PGT utilizes the state of the art Luminex 200 platform, FDA approved xTAG technologies, as well as laboratory-developed methods. The test is a simple non-invasive, buccal cell-based cheek swab. The PGT has a short turn-around time and easy to read lab reports.

Seniors, cancer, regimen of medications, sensitive,wants less drug reactions

Individuals who may benefit from PGT include patients with abnormally high or low metabolite to substrate ratios in urine drug screening, patients with multiple organ system issues or on multiple medications, patients who suffer from debilitating adverse drug reactions, and patients who have gone through sequential ineffective drug trials. PGT is proven a useful tool in chronic pain management where the use of narcotics and other medication is likely.

Hospitalization,death and other adverse drug reactions

According to the FDA, adverse drug reactions cause over 2 million hospitalizations per year and 106,000 annual deaths, while contributing $136 billion dollars to annual health care costs in our country. These are terrible statistics but the worst part is they are largely avoidable. The best part is that the technology is now available to every physician to ensure patient safety and the best possible treatment plan.

 

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