DEC 2025

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MedCheck in English No.34

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Contents

Editorial

Questioning “No Serious Safety Concerns” in Vaccines

 

Review
 

Critical Analysis of the 2025 Hypertension Guidelines

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投稿 Medcheck in English No.34（DEC 2025)NEW!! は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Aug 2025

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MedCheck in English No.33

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Contents

Editorial

 　Information Sharing to Prevent Adverse Reactions

 

Review
 　From Familiar Adverse Reactions to 
 　  Adverse Reaction-Prescribing Cascades

 

Adverse Reactions  
 Reproductive Toxicity of Paroxetine (Paxil)
　-Focus on Withdrawal Syndrome and Persistent Pulmonary Hypertension- 
　Preclinical part of Summary Technical Documentation for paroxetine (Paxil)（in Japanese)

 

Memorial Tribute
　Mr. Charles Medawar
　　A lifetime of activities breaking down barriers  between patients and medical professionals
a

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投稿 MedCheck in English No 33 (Aug 2025) は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents
Editorial
 　Why difficult to evaluate drug efficacy and harm?

New Products
 　RSV vaccine (Abrysvo^®) :
 　   Harms and suspected false negatives & allocation bias

Topic  
 　How to Review Clinical Trials of new product
        　Intranazal flu vaccine, FluMist^® as an example  

Questions and Comments
    What is the theoretical basis for healthy vaccinee effect?
a

Errata (Typos):  PDF is already corrected
line 2-3, right column on p7
   Before:vaccine group as in the placebo group (5 vs. 12 cases, respectively) 
   Corrected: placebo group as in the vaccine group (12 vs. 5 cases, respectively)
line 3 from the bottom of right column on p15
   Before: 39.8% in the placebo group
   Corrected:39.8% in the vaccine group
For others, see the table for Errata

投稿 MedCheck in English No 32 (April 2025） は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents
Editorial
    Why a harmful and useless agent became an expensive new drug?

New Products 
   Alzheimer’s new drug “donanemab”:
         ・Increases hemorrhagic stroke with deaths 
                  Web-Appendix Free
         ・If you want to see Japanese-written documents in which
           hemorrhagic stroke events are described, please refer:
                 Web-Appendix in Japanese Free
         ・Summary opinion of this review distributed by Kyodo News
              (October 30, 2024) and some recent example clippings with
             English translation:  News paper clippings Free　

Adverse Reactions
    Paroxetine:
             Hostility, aggression, violence, agitation and crime

投稿 MedCheck in English No.31 (December 2024) は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents
Editorial
What the Government Should Do Before Introducing the Replicon Vacce
(self-amplifying mRNA vaccine)

New Products related
       Palivizumab (Synagis®): in RSV high-risk Children
           Is it useful for preventing RSV infection?
          Supplementary Appendix Free

New Products
      Nirsevimab (Beyfortus®): for universal immunization against RSV
           RSV-related hospitalizations decrease, but deaths increase
          Supplementary Appendix Free

投稿 MedCheck No. 30（September 2024) は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents
Editorial
Healthy vaccinee effect: a key bias in observational studies

Review
HPV vaccine increase total and cancer mortality without evidence of HPV-related cancer decrease

1.RCTs show increased cancer and total mortality
2. All observational studies failed to provide evidence for invasive cancer prevention
3.  Column: Healthy vaccinee effect in observational studies
Supplementary Appendix Free

Erratum
References 23 and 24 for the main text are corrected to as ffollows:
23) Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, Garland SM, Chatterjee A, Lazcano-Ponce E, et al. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double blind, randomised controlled VIVIANE study. Lancet Infectious Diseases 2016;16(10):1154-68.
24) Skinner SR, Szarewski A, Romanowski B, Garland SM, Lazcano-Ponce E, Salmeron J. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet 2014;384(9961): 2213–27.

投稿 MedCheck No29 （May 2024） は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents

Editorial
 　Unavoidable adverse reactions to Alzheimer’ s agent

Review
 　Lecanemab removes substitute of lost cells leading to brain
 　hemorrhage and atrophy

Vaccine Information
     Is it true： “Several vaccines reduce Alzheimer’ s disease” ?
       Beware of distortion by healthy-vaccine effect

New Products
    GLP-1 agonist for obesity: Semaglutide (Wegovy)
       Too many adverse effects including suicide. Do not use ！

Errata for line 13-14, left column on p54 (PDF is already corrected)
Before:
           Adrenergic-mediated action is essential for weight
       loss with GLP-1 agonists [16]. 
Corrected: 
            Adrenergic-mediated action is essential for weight
        loss with GLP-1 agonists, because GLP-1 did not decrease
       body weight of triple beta-adrenoreceptor knockout
        mice [16]

投稿 MedCheck No 28 (December 2023) は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents

Editorial
Be Vigilant On a New Anti-Alzheimer’s Drug

Review
Lecanemab for Alzheimer’s disease
　No evidence to delay progress, should not be approved
          Supplementary Appendix Free

COVID-19 Information
SARS-CoV-2 Vaccine Increases Arryuthmia Mortality
          Supplementary Appendix Free

SARS-CoV-2 Vaccine Increases Venous Thrombosis Mortality
          Supplementary Appendix Free

Vaccines and monoclonal antidies: ineffective
          Supplementary Appendix Free

投稿 MedCheck No 27 (September 2023) は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents

Editorial
Ineffective substances should not be approved

Review
SGLT2 inhibitors should not be used
No proof of efficacy both for diabetes and heart failure

Review
HPV vaccines:
Seriously harmful and do not prevent cervical cancer

Adverse Reactions
Tacrolimus ointment:
Robust carcinogenicity including malignant lymphoma

投稿 Med Check No 26 (April 2023) は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。

Contents

Editorial
Unacceptable Proposal: Experts ignored clinical trials
Review
   To be Vaccinated, or Not ? Points You should Know
   SARS-CoV-2 Vaccines Doubles the Risk of COVID-19!
      (1) “Harm-benefit balance” depends on the situation
(2) Types of vaccines and adjuvants
(3) Healthy vaccinee effect (bias)
(4) The doctrine of original antigenic sin and Omicron variants
Figure 6: Types of vaccines and their structures

投稿 Med Check – No 25 (December 2022) は 薬のチェック | 医薬ビジランスセンター に最初に表示されました。