The AERS search identified 2 fatal pediatric cases and 10 non-fatal serious pediatric cases associated with rosuvastatin use from 2003-2010. Both fatal cases involved in utero exposure to rosuvastatin. Of the 10 non-fatal cases, 7 involved accidental exposure in children under 3 years old. The other cases included a suicide attempt, in utero exposure, and diarrhea with increased liver enzymes in a 16-year-old transplant patient taking rosuvastatin. The cases did not identify adverse events unique to pediatrics. More information would be needed to determine if rosuvastatin caused the reported events.
The Expanding Influence of Digital Tools on Healthy Behaviours AIA Singapore
Steven Tucker, Medical Director of Tucker Medical shared about how we are experiencing a new wave of digital technology in healthcare and how companies can utilise these tools to create a healthier workplace at the recent AIA Vitality Summit 2017.
Hypertension in pregnancy is a major killer disease, this presentation explores the review of contemporary evidence in the management of acute severe hypertension,
To tell or not to tell a case report of Ludwig Angina in a patient with ische...Cecilia Young 楊幽幽
To tell or not to tell? a case report of ludwig angina in a patient with ischemic heart disease – the wife stopped the dentist from telling the truth
Young C* and Fong KWY
Independent Researcher, Lai Chi Kok Road, Kowloon, Hong Kong
Đặc điểm điện di huyết sắc tố và kiểu gene hội chứng thai tích dịch do Hb Bart'sVõ Tá Sơn
Electrophoresis features and genotypes of Hb Bart’s hydrops fetalis
Đặc điểm điện di huyết sắc tố và kiểu gene hội chứng thai tích dịch do Hb Bart's
bsvotason
bs võ tá sơn
bác sĩ võ tá sơn
The Expanding Influence of Digital Tools on Healthy Behaviours AIA Singapore
Steven Tucker, Medical Director of Tucker Medical shared about how we are experiencing a new wave of digital technology in healthcare and how companies can utilise these tools to create a healthier workplace at the recent AIA Vitality Summit 2017.
Hypertension in pregnancy is a major killer disease, this presentation explores the review of contemporary evidence in the management of acute severe hypertension,
To tell or not to tell a case report of Ludwig Angina in a patient with ische...Cecilia Young 楊幽幽
To tell or not to tell? a case report of ludwig angina in a patient with ischemic heart disease – the wife stopped the dentist from telling the truth
Young C* and Fong KWY
Independent Researcher, Lai Chi Kok Road, Kowloon, Hong Kong
Đặc điểm điện di huyết sắc tố và kiểu gene hội chứng thai tích dịch do Hb Bart'sVõ Tá Sơn
Electrophoresis features and genotypes of Hb Bart’s hydrops fetalis
Đặc điểm điện di huyết sắc tố và kiểu gene hội chứng thai tích dịch do Hb Bart's
bsvotason
bs võ tá sơn
bác sĩ võ tá sơn
Update (2021) Oral Contraceptive Pill : Dr. Jyoti Agarwal Dr Sharda Jain Lifecare Centre
Update (2021) Oral Contraceptive Pill : Dr Sharda Jain
7 Billion 2011 & increasing a rate of 150 million per year
INDIA
Today – 1.3 billion 2050 – 1.628 expected
Liao2011 phân tích máu cuống rốn để khẳng định chẩn đoán nhanh trước sinh bện...Võ Tá Sơn
CORD BLOOD ANALYSIS FOR RAPID PRENATAL CONFIRMATION OF Hb BART’S DISEASE USING THE SEBIA CAPILLARY ELECTROPHORESIS SYSTEM
Liao2011 phân tích máu cuống rốn để khẳng định chẩn đoán nhanh trước sinh bệnh Hb Bart's bằng cách sử dụng hệ thống điện di mao quản
bs võ tá sơn
bsvotason
bác sĩ võ tá sơn
This Journal Club presentation provides a summary and discussion of the following free access article published in UOG:
Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis
A. Sotiriadis, S. Papatheodrou, G. Makrydimas
Volume 40, Issue 3, Date: September 2012, pages 257-266
It can be accessed here:
http://onlinelibrary.wiley.com/doi/10.1002/uog.11178/abstract
Recurrent pregnancy loss (RPL), also referred to as recurrent miscarriage or habitual abortion, is historically defined as 3 consecutive pregnancy losses prior to 20 weeks from the last menstrual period.
This Presentation is made by Dr.Laxmi Shrikhande
Using Multiple Data Sets to Build a Surveillance System for Hemoglobinopathie...ghpc
Along with six other states, Georgia participated in the two-year Registry and Surveillance System for Hemoglobinopathies (RuSH) pilot project. The Georgia Health Policy Center presented this poster about the project at the Center for Disease Control and Prevention's 2nd National Conference on Blood Disorders in Public Health in March 2012.
Global Medical Cures™ | Heart Disease Medicines
ACE Inhibitors & ARBs: Patients Guide for those suffering from Stable Coronary Heart Disease
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | NEW YORK STATE- Cardiovascular Disease MortalityGlobal Medical Cures™
Global Medical Cures™ | NEW YORK STATE- Cardiovascular Disease Mortality
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Update (2021) Oral Contraceptive Pill : Dr. Jyoti Agarwal Dr Sharda Jain Lifecare Centre
Update (2021) Oral Contraceptive Pill : Dr Sharda Jain
7 Billion 2011 & increasing a rate of 150 million per year
INDIA
Today – 1.3 billion 2050 – 1.628 expected
Liao2011 phân tích máu cuống rốn để khẳng định chẩn đoán nhanh trước sinh bện...Võ Tá Sơn
CORD BLOOD ANALYSIS FOR RAPID PRENATAL CONFIRMATION OF Hb BART’S DISEASE USING THE SEBIA CAPILLARY ELECTROPHORESIS SYSTEM
Liao2011 phân tích máu cuống rốn để khẳng định chẩn đoán nhanh trước sinh bệnh Hb Bart's bằng cách sử dụng hệ thống điện di mao quản
bs võ tá sơn
bsvotason
bác sĩ võ tá sơn
This Journal Club presentation provides a summary and discussion of the following free access article published in UOG:
Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis
A. Sotiriadis, S. Papatheodrou, G. Makrydimas
Volume 40, Issue 3, Date: September 2012, pages 257-266
It can be accessed here:
http://onlinelibrary.wiley.com/doi/10.1002/uog.11178/abstract
Recurrent pregnancy loss (RPL), also referred to as recurrent miscarriage or habitual abortion, is historically defined as 3 consecutive pregnancy losses prior to 20 weeks from the last menstrual period.
This Presentation is made by Dr.Laxmi Shrikhande
Using Multiple Data Sets to Build a Surveillance System for Hemoglobinopathie...ghpc
Along with six other states, Georgia participated in the two-year Registry and Surveillance System for Hemoglobinopathies (RuSH) pilot project. The Georgia Health Policy Center presented this poster about the project at the Center for Disease Control and Prevention's 2nd National Conference on Blood Disorders in Public Health in March 2012.
Global Medical Cures™ | Heart Disease Medicines
ACE Inhibitors & ARBs: Patients Guide for those suffering from Stable Coronary Heart Disease
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | NEW YORK STATE- Cardiovascular Disease MortalityGlobal Medical Cures™
Global Medical Cures™ | NEW YORK STATE- Cardiovascular Disease Mortality
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Harmful Interactions
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | SUNSCREEN Facts
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Healthy Muscles Matter
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™| New York Arthritis Prevalence
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™| Smokeless Tobacco: Guide for Quitting
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | National Strategy for Combating Antibiotic Resistant ...Global Medical Cures™
Global Medical Cures™ | National Strategy for Combating Antibiotic Resistant Bacteria
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Womens Health-NUTRITION
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | New York State Disability Chartbook
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Lactose Intolerance & Osteoporosis
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | BREAST CANCER- Reducing the Risk with MedicineGlobal Medical Cures™
Global Medical Cures™ | BREAST CANCER- Reducing the Risk with Medicine
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | NEW YORK STATE- Adult Overweight & Obesity StatisticsGlobal Medical Cures™
Global Medical Cures™ | NEW YORK STATE- Adult Overweight & Obesity Statistics
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ |Family Guide for Nutrition & Physical ActivityGlobal Medical Cures™
Global Medical Cures™ |Family Guide for Nutrition & Physical Activity
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Your Glucose Meter
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Helping your Overweight Child
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
A slide series to learn and appreciate the importance and the potential of Personalized/Individualized Genomic Medicine. It briefly goes through the idea of biotechnology and the advancements we have made in biology and technology. A series of applications for genomic medicine is then explored, not failing to mention the challenges we have to overcome as well, for the next medical revolution.
A case for personalized medicine is presented.
PROGNOSTIC VALUE OF PERIPHERAL BLOOD BLAST PERCENTAGE ON DAY 8 IN LONG TERM ...NeetiVaghela
To correlate the peripheral blood blast
percentage of day1 and day 8 in patients with acute lymphoblastic
leukemia (ALL) post chemotherapy in long term cure outcome.
Global Medical Cures™ | NEULASTA- Pediatric PostMarketing Adverse Event ReviewGlobal Medical Cures™
Global Medical Cures™ | NEULASTA- Pediatric PostMarketing Adverse Event Review
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Antipsychotics and mood stabilizers in pregnancyMohamed Sedky
Objectives:
Background risk of spontaneous congenital anomalies
The impact of mental illness on pregnancy
The impact of pregnancy on mental illness
The impact Antipsychotics and mood stabilizers on pregnancy outcome
Recommendations for prescribing during pregnancy
What to include in discussions with a pregnant women
Adenylosuccinate Lyase Deficiency (ADSL) and Report the First Case from Iransuppubs1pubs1
Adenylosuccinate lyase deficiency is a neurometabolic disorder associated by accumulation of succinylpurines in body fluids that causes encephalopathy. It’s a rare neurological dysfunction with psychomotor retardation and epilepsy. We introduce here a five-and-a-half-year-old patient who was referred to the Neurology Department, Mofid Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Lipid Screening in Childhood for Detection of Multifactorial DyslipidemiaGlobal Medical Cures™
Lipid Screening in Childhood for Detection of Multifactorial Dyslipidemia
IMPORTANT NOTE TO USERS OF WEBSITE & DOCUMENTS POSTED ON SLIDESHARE- Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
www.globalmedicalcures.com
Skin Cancer Screening
IMPORTANT NOTE TO USERS OF WEBSITE & DOCUMENTS POSTED ON SLIDESHARE- Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
www.globalmedicalcures.com
Global Medical Cures™ | USA Chartbook on HealthCare for Blacks
IMPORTANT NOTE TO USERS OF WEBSITE & DOCUMENTS POSTED ON SLIDESHARE- Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
www.globalmedicalcures.com
Global Medical Cures™ | Older Americans- Key Indicators of Well Being Global Medical Cures™
Global Medical Cures™ | Older Americans- Key Indicators of Well Being
IMPORTANT NOTE TO USERS OF WEBSITE & DOCUMENTS POSTED ON SLIDESHARE- Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
www.globalmedicalcures.com
Global Medical Cures™ | Staggering Increase in Generic Drugs PricingGlobal Medical Cures™
Global Medical Cures™ | Staggering Increase in Generic Drugs Pricing
Disclaimer
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Dangers & Consequences of Marijuana Abuse
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Medicines for Treating Depression
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Women & Depression
Disclaimer:
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | PCAST Report- Combating Antibiotic ResistanceGlobal Medical Cures™
Global Medical Cures™ | PCAST Report- Combating Antibiotic Resistance
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Physical Activity Guidelines for Americans
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Dietary Guidelines for Americans
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Aging and your Eyes
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Help your Child gain control over Asthma
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Drugs approved for Bone Cancer
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Drugs approved for Breast Cancer
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™| Drugs approved for Head and Neck Cancer
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Drugs approved for Non Hodgkin Lymphoma
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™| Drugs approved for Pancreatic Cancer
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Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Drugs approved for LUNG CANCER
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Global Medical Cures™ | Anger Management for Substance Abuse & Mental Health ...Global Medical Cures™
Global Medical Cures™ | Anger Management for Substance Abuse & Mental Health Clients
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Global Medical Cures™ | Crestor- Post Marketing Adverse Event Review
1. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Surveillance and Epidemiology
December 3, 2010
To: Lisa L. Mathis MD, Acting Director
Pediatric and Maternal Health Staff (PMHS)
Office of New Drugs (OND), CDER
M. Dianne Murphy, MD, Director
Office of Pediatric Therapeutics (OPT), OC
Thru:
Ann McMahon, MD, Deputy Director
Lanh Green Pharm.D. Safety Evaluator, Team Leader
Division of Pharmacovigilance (DPVI)
Office of Surveillance and Epidemiology (OSE), CDER
From: Quocbao Pham Pharm.D., Safety Evaluator
Division of Pharmacovigilance (DPV) I
Office of Surveillance and Epidemiology (OSE), CDER
Subject: BPCA & PREA: Pediatric Postmarketing Adverse Event Review
Drug Name(s): Crestor (Rosuvastatin Calcium)
Pediatric Exclusivity
Approval Date:
July 7, 2009
Application Type/Number: NDA 21-366
Applicant/sponsor: IPR Pharmaceuticals, Inc.
OSE RCM #: 2010-2017
Reference ID: 2871042
2. 1 INTRODUCTION
In accordance with the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research
Equity Act (PREA), this review summarizes post-marketing cases of adverse events associated
with the use of Crestor (rosuvastatin) in pediatric patients 0-16 years of age identified in the
Adverse Events Reporting System (AERS) database. The Office of Pediatric Therapeutics
requested this review in preparation for the Pediatric Advisory Committee (PAC) meeting
scheduled for March 2011. The focus of this review is on all serious (fatal and non-fatal) adverse
events in children 0-16 years of age and from August 12, 2003 (approval) to August 18, 2010.
OSE was requested to compare the adverse events between children and adults, highlighting
growth, liver, kidney, and muscle disorders.
Rosuvastatin calcium is an HMG Co-A reductase inhibitor (statin) approved for use in pediatric
patients 10-17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce
elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy. Pediatric studies
for safety and efficacy were performed in response to a Written Request on March 7, 2006 and
fulfilled the Pediatric Research Equity Act (PREA) post-marketing requirement (PMR) for the
supplemental application in patients 10-17 years. Exclusivity was granted on July 7, 2009. The
pediatric study requirement for ages 0 to 9 years were waived (reason not specified).
Pertinent Pediatric Safety Labeling:
Contraindications, Women who are pregnant or may become pregnant and nursing mothers.
Dosing and Administration, HeFH in Pediatric Patients 10 to 17 years of age (2.2): The usual
dose range of Crestor is 5-20 mg/day; the maximum recommended dose is 20 mg/day (doses
greater than 20 mg have not been studied in this patient population).
Adverse Reactions, Pediatric Patients 10 to 17 years of age (6.2): Elevations in serum creatine
phosphokinase (CK) > 10x ULN were observed more frequently in rosuvastatin compared with
placebo-treated children.
Use in Specific Population, Pregnancy (8.1): Crestor may cause fetal harm when administered to
a pregnant woman. If the patient becomes pregnant while taking Crestor, the patient should be
apprised of the potential risks to the fetus and the lack of known clinical benefit with continued
use during pregnancy.
Use in Specific Population, Pediatric Use (8.4): Although not all adverse reactions identified in
the adult population have been observed in clinical trials of children and adolescent patients, the
same warnings and precautions for adults should be considered for children and adolescents.
Use in Specific Population, Pediatric Use (8.4): Crestor has not been studied in controlled
clinical trials involving prepubertal patients or patients younger than 10 years of age.
2 AERS SEARCH CRITERIA
AERS database was searched for all adverse events reported for NDA #021-366 (to include
tradename Crestor and synonyms) from an FDA received date of August 12, 2003 to August, 18,
2010.
Reference ID: 2871042
3. 3 AERS RESULTS FOR ROSUVASTATIN (TABLE 1)
Table 1: Crude counts1
of AERS Reports from All Sources
From Approval Date (August 12, 2003) to (August, 18, 2010)
All reports (US)2
Serious3
(US) Death (US)
Adults (≥ 17 yrs.) 11690(9205) 8191(5912) 270(111)
Pediatrics (0-16 yrs.) 17(8) 14(5) 3(2)
Age unknown (Null values) 4006(3653) 2272(1955) 59(43)
Total 15713(12866) 10447(7872) 332(156)
1
May include duplicates
2
US counts in parentheses
3
Serious adverse drug experiences per regulatory definition (CFR 314.80) include outcomes of death, life-threatening, hospitalization
(initial or prolonged), disability, congenital anomaly and other serious important medical events.
AERS retrieved a total of 17 cases of adverse events in children aged 0-16 years from August 12,
2003 to August, 18, 2010 for Crestor (rosuvastatin) NDA #021-366. A similar search for adult
patients yielded 11,690 reports for the same period. After a hands-on review, one duplicate case
and four cases1
involving adult patients were excluded. Twelve unduplicated adverse events
reports in children remained. Characteristics of the 12 pediatric cases in this series are presented
in Table 2.
The 59 fatal cases involving patients with “unknown” ages were also retrieved. A hands-on
review of these cases found three duplicates2
to a case already included in this review (ISR
#6299864). Of the remaining 56 cases, 34 cases involved adult patients, and 22 cases did not
identify the patient as an adult or child.
1
ISR# 6120652, 6138390, 5903147, 5236734
2
ISR# 6267856, 6252460, 6253638
Reference ID: 2871042
4. Table 2. Characteristics of Serious and Severe Pediatric Adverse Event Cases with Rosuvastatin (n=12)
ISR #
Source
Reporter Age Gender
Adverse
Events
Comments
5371700
Foreign
Physician 23
Months
Female Accidental
Exposure
Child was asymptomatic. It was not known if she swallowed any pills. Activated
charcoal was administered and blood was collected. Results and outcome not reported.
5239254
Domestic
Consumer 24
Months
Female Accidental
Exposure
Child took one Crestor 10mg tablet and was then “dancing around”. No other
information reported. Case was reported as Non-serious.
6147080
Foreign
Foreign
Regulator NR Male
In Utero
Exposure,
Congenital
Hemangioma
37-year-old mother was on ezetimibe and rosuvastatin. When pregnancy was diagnosed,
ezetimibe was stopped. Mom delivered a “healthy female baby”. The baby then
experienced congenital hemangioma which persisted. Reporter did not feel that
hemangioma was related to rosuvastatin.
6299864
Domestic
Physician 5
Hours
Male
In Utero
Exposure;
Death
28-year-old mother was on rosuvastatin, glyburide/metformin, modafinil, oxybutynin,
gabapentin, and interferon-beta while pregnant. Diagnosis of pregnancy made at 4 weeks
gestation, all medications were stopped. Ultrasound at 12 weeks and 18 weeks showed
significant anomalies. Mother refused advice to abort pregnancy. She had an emergency
c-section at 36-week gestation. Baby boy passed away 5 hours after birth.
6405264
Foreign
Consumer 30
Months
Female Accidental
Exposure
Child took 2.5mg of Crestor 2-3 times. No other information reported.
6405319
Foreign
Consumer 14
Months
Female Accidental
Exposure
Child took 1.5 tablets of 5mg Crestor. Unspecified symptoms developed. No other
information reported.
6405328
Foreign
Foreign
Regulator
22
Months
Male Accidental
Exposure
Child took 5mg tablet of Crestor with four other drugs (names not reported). No outcome
or other information was reported
6405356
Foreign
Consumer 18
Months
Male Accidental
Exposure
Child took 2.5mg tablet of Crestor. No other information was reported.
6511079
Domestic
Physician 16
Years
Female Diarrhea,
↑LFT
Complicated 16-year-old patient with medical history of liver transplant and double lung
transplant was started on Crestor 2.5-10mg (exact dose not reported) for high
triglycerides on 1/7/2009. She experienced diarrhea and elevated liver enzymes and
Crestor was discontinued on 2/19/2009. Outcome was not reported.
6547230
Foreign
Physician NR Female
In Utero
Exposure;
Death
Mother was on Crestor 20mg daily while pregnant. On ultrasound the fetus was
diagnosed with extreme bradycardia (date not reported). Crestor was stopped and the
fetus subsequently died. No other information reported.
6714852
Foreign
Physician 13
Years
Male Suicide
Attempt
13-year-old girl attempted suicide by taking 3 tablets of Crestor and candesartan that
were prescribed to her father. The girl experienced paleness and tremor. She was taken to
the ER. Cardiac function did not show any alteration. Hepatic, renal, and electrolyte tests
were done but results not reported. However, her symptoms were improving. No other
information or outcome was reported.
6719206
Foreign
Consumer 18
Months
Male
Possible
Accidental
Exposure
Child took 6 Crestor 10 mg tablets and he was taken to the hospital. He experienced
pyrexia and peripheral coldness. The reporting father stated that the symptoms might
have been due to “teething” and that the child might not have taken Crestor.
Reference ID: 2871042
5. 4 SUMMARY OF RESULTS
The AERS search identified two fatal pediatric cases and 10 non-fatal serious pediatric cases
from August 12, 2003 to August, 18, 2010, in association with rosuvastatin use. Both fatal cases
involved in utero exposure to rosuvastatin. The 10 non-fatal cases had the following adverse
events: accidental exposure (n=7), suicide attempt (n=1), in utero exposure / hemangioma (n=1),
and diarrhea / increased liver function tests (n=1).
4.1 FATAL CASES (N=2, 1 FOREIGN, 1 DOMESTIC)
Case 1 (ISR# 6299864) involved in utero exposure with rosuvastatin. A 28-year-old mother was
taking rosuvastatin 10mg daily for high cholesterol. Her other maintenance medications included
glyburide/metformin, modafinil, oxybutynin, gabapentin and interferon beta. She had a history of
two previous pregnancies (one vaginal, one cesarean), high cholesterol, diabetes, and multiple
sclerosis. Her last menstrual period was April 21, 2007. She found out she was pregnant on May
26, 2007 (approximately 4 weeks gestation). All medications were stopped. At 12-weeks, an
ultrasound showed that her baby had a large fluid pocket on his neck. At 18-weeks, an ultrasound
showed that baby had a club foot, shortened thigh bone, curvature of his spine. The mother was
advised to abort the pregnancy, but she refused. She did not feel her baby move until 28-weeks.
On December 25, 2007, at 36-weeks gestation, she had contractions and went into labor.
Attempts to stop labor were unsuccessful and a cesarean section was performed. The baby was
born blue with underdeveloped bones and lungs. He was sedated, intubated, and brought to the
NICU. On December 26, 2007, at five-hour-old, the baby died. The mother refused to have an
autopsy performed.
Case 2, (ISR# 6547230) involved in utero exposure with rosuvastatin. The mother was taking
rosuvastatin 20mg daily and escitalopram (dose not reported) while pregnant. By ultrasound, the
baby was diagnosed with extreme bradycardia (date not reported). Rosuvastatin was stopped and
the fetus subsequently died. No other information was reported.
4.2 NON-FATAL (N=10, 7 FOREIGN, 3 DOMESTIC)
Seven of the 10 non-fatal cases involved accidental exposure of rosuvastatin to a baby. However,
none of the seven cases provided enough detail to evaluate for adverse reactions. Three cases
assessed for symptoms: 1) pyrexia with peripheral coldness; 2) “dancing around”; 3)
“asymptomatic”. In the case (ISR#6719206) involving pyrexia and peripheral coldness, the
reporter (consumer) stated that the symptoms might have been due to “teething” and that his son
might not have been exposed to rosuvastatin. The remaining four accidental exposure cases did
not provide information beyond the fact that rosuvastatin was ingested.
Two other cases included a suicide attempt and an in utero exposure to rosuvastatin. 1) A 13-
year-old girl attempted to commit suicide by taking 3 tablets each of rosuvastatin and candesartan
(strengths of tablets were not reported) that were prescribed to her father. The girl experienced
“paleness and tremor” and was taken to the ER. Cardiac function “did not show any alteration”.
Hepatic, renal, and electrolyte tests were performed but results were not reported. The girl’s
symptoms improved but a final outcome was not reported. 2) A 37-year-old mother was taking
ezetimibe and rosuvastatin (dose and duration not reported). When she became pregnant,
ezetimibe was stopped (status of rosuvastatin was not reported). It was reported that she delivered
a “healthy female baby”. Subsequently, the baby experienced congenital hemangioma which
persisted (dates not provided). No other information was provided.
The remaining case involved a 16-year-old girl with a past medical history of liver transplant and
double lung transplant. On January 7, 2009, she started rosuvastatin 2.5-10mg (exact dose not
Reference ID: 2871042
6. reported) for high triglycerides. She subsequently experienced diarrhea and elevated levels of
liver enzymes. Rosuvastatin was discontinued on February 19, 2009.
5 DISCUSSION
A review of the AERS pediatric cases did not identify adverse events unique to the pediatric
population. Two fatal cases involved in utero exposure to rosuvastatin. However, both cases were
difficult to assess for causality because of the mothers’ complicated medical situation in one case
and insufficient details reported in the other.
The consult requested DPVI to focus on growth, liver, kidney, and muscle disorders. However,
11 of the 12 cases in this series did not specifically involve these disorders. Seven cases were
accidental exposures to children less than 3-year-old; three cases were in utero exposures; and
one case was a suicide attempt by a 13-year-old.
Three adverse reactions from rosuvastatin in children were observed in these 11 cases. One case
described paleness and tremors but the patient also ingested three tablets of candesartan during
her suicide attempt. A second case described pyrexia and peripheral coldness but little detail was
reported. A third case reported the child was “dancing around” after ingesting rosuvastatin, which
did not provide enough detail to assess. No other symptoms were described in these 11 cases.
The remaining 12th
case in this series involved a 16-year-old girl with history of liver and bilateral
lung transplants experiencing diarrhea and increased levels of liver enzymes (LFTs) after starting
rosuvastatin. Increased LFTs are labeled events for Crestor, and diarrhea is a non-specific
symptom. It is plausible that Crestor is associated with these adverse events. However
considering the patient’s complex health status, other possible etiologies also exist. For instance,
immunosuppressant therapies used after transplantation can cause diarrhea and increased LFTs.
Additionally, signs and symptoms of liver graft rejection include diarrhea and increased LFTs.
Thus, with one confounded case of increased LFTs and diarrhea, DPV1 will continue to monitor
these events.
From this case series, two concerns were indentified: accidental exposure of rosuvastatin in
children and the use of rosuvastatin during pregnancy. The former concern will require further
analysis by the Division of the Medication Error Prevention Analysis (DMEPA) to assess the risk
of unintended exposure of rosuvastatin in children. The relevant cases in this review have been
forwarded to DMEPA. The latter concern appears to be adequately addressed in rosuvastatin’s
label. Crestor is contraindicated in women who are or may become pregnant. It has a pregnancy
category of “X” and the Use in Specific Population, Pregnancy Section (8.1) of the label states
that rosuvastatin “may cause fetal harm when administered to a pregnant woman” and that “the
patient should be apprised of the potential risks to the fetus and the lack of known clinical benefit
with continued use during pregnancy.”
Reference ID: 2871042
7. 6 CONCLUSION
Based on the review of AERS pediatric cases associated with rosuvastatin calcium, accidental
exposure and use during pregnancy were identified as potential concerns. The risk of Crestor use
during pregnancy appears to be adequately addressed in the label. Crestor’s label contains strong
language to discourage its use during pregnancy, and Crestor has a pregnancy category of “X”.
The risk of accidental exposure in children, however, has not been assessed. DPVI defers to
DMEPA for this risk assessment. The relevant cases in this review have been forwarded to
DMEPA for further analysis.
Few adverse reactions were identified in AERS for the pediatric population because most cases
described were either accidental or in utero exposures. The two adverse events (diarrhea and
increased LFTs) observed in this case series occurred in a patient with a history of liver and
bilateral lung transplants. Post-transplant therapies and liver transplant rejection are known to
increase LFTs and cause diarrhea. Thus, alternative etiologies for these adverse reactions exist
and confound Crestor’s role. Additionally, increase in LFTs is known to occur with Crestor use in
adults and is described in the labeling.
At this time, DPVI recommends no labeling changes and will continue to monitor the adverse
events for Crestor.
Reference ID: 2871042
8. ---------------------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
---------------------------------------------------------------------------------------------------------
/s/
----------------------------------------------------
QUOCBAO PHAM
12/03/2010
LANH GREEN
12/03/2010
ANN WARD W MCMAHON
12/03/2010
I concur.
Reference ID: 2871042