Posts

Showing posts with the label Adverse Events

Recent Drug Safety Alerts – Asrar Qureshi’s Blog Post #1125

Image
Recent Drug Safety Alerts – Asrar Qureshi’s Blog Post #1125 Dear Colleagues! This is Asrar Qureshi’s Blog Post 1125 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com . Please email to pharmaveterans2017@gmail.com   for publishing your contributions here. Covid Vaccine Scop Transdermal System Xyzal Zyrtec Preamble Post Marketing Surveillance, Pharmacovigilance, and Adverse Drug Reactions Reporting are tools through which adverse reactions are reported from various parts of the world. The activity is more seriously undertaken in the developed countries. The information thus collected is investigated in detail to see if the adverse reaction was caused by the drug or were other factors involved in the outcome. On the basis of the investigation, the regulatory authorities like USFDA, EMA, TGA etc. issue instructions to add cautions or warnings or black box warnings in the prescribing information or on the pack or b...

Colossal Wrongdoings by Big Pharma – Servier – Asrar Qureshi’s Blog Post #1094

Image
Colossal Wrongdoings by Big Pharma – Servier – Asrar Qureshi’s Blog Post #1094 Dear Colleagues! This is Asrar Qureshi’s Blog Post #1094 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com. Please email to pharmaveterans2017@gmail.com  for publishing your contributions here. Credit: Andres Ayrton Credit: Annushka Ahuja Credit: Artem Podrez Preamble For decades, benfluorex – sold under the brand name ‘Mediator’, was marketed as a diabetes and weight-loss drug by French pharmaceutical giant Servier Laboratories. Hailed as a useful tool to help overweight patients manage their health, Mediator was widely prescribed in France and a few other countries from the mid-1970s until 2009. But beneath its therapeutic promise lurked a dangerous reality: the drug was linked to serious, and often fatal, heart valve problems and pulmonary hypertension. By the time it was pulled off the market, Mediator was estimated to have caus...

Withdrawal of Medicines is Quite Common – Asrar Qureshi’s Blog Post #884

Image
Withdrawal of Medicines is Quite Common – Asrar Qureshi’s Blog Post #884 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #884 for Pharma Veterans. Pharma Veterans  aims to share knowledge and wisdom from Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Credit: Anna Shvets Credit: Polina Tankilevich Credit: Wesley Davi My first experience with the withdrawal of a medicine was just a few months after I started working in 1975. We had an injectable antibiotic Reverin (rolitetracycline) which had two variations: intravenous and intramuscular. One day, we received the instructions that the product was being withdrawn and that we had to go to every pharmacy in our area, count the physical stock of the product, and make a credit note, one copy for the pharmacy and one for the office. It was not a widespread product...

More Facts About Pfizer-BioNTech Covid Vaccine – Last Part – Asrar Qureshi’s Blog Post #755

Image
More Facts About Pfizer-BioNTech Covid Vaccine – Last Part – Asrar Qureshi’s Blog Post #755 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #755 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: EVG Kowalievska Photo Credit: Ketut Subiyanto Photo Credit: Max Fischer An excerpt from a study published on 5th January 2023 in BMC Infectious Diseases Journal. The study was conducted in the Palestinian territory.  [Quote] Approximately one-third of participants reported no adverse effects after receiving the first, second, or third dose of the Pfizer vaccine, with 34%, 33.6%, and 32.5%, respectively. Participants who received more than one dose experienced more side effects. The most commonly reported adverse effects were ...

More Facts About Pfizer-BioNTech Covid Vaccine – Part 4 – Asrar Qureshi’s Blog Post #754

Image
More Facts About Pfizer-BioNTech Covid Vaccine – Part 3 – Asrar Qureshi’s Blog Post #754 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #754 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: Anna Shvets Photo Credit: August de Richelieu Photo Credit: Nataliya Vaitkevich NINE PAGES REFERENCE There is much talk about 9 pages of side effects. This comes from Pfizer/FDA document titled ‘BNT 162b2 – 5.3.6 – Cumulative Analysis of Adverse Events Reports. The 9-pages are Appendi1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST. It is a lot of medical terminology which is not relevant for non-medical people. You may follow the link to see these adverse events. In all, it is a 38-page document (including 9 pages). I shall give some o...

More Facts About Pfizer BioNTech Covid Vaccine – Part 3 – Asrar Qureshi’s Blog Post #754

Image
More Facts About Pfizer BioNTech Covid Vaccine – Part 3 – Asrar Qureshi’s Blog Post #754 Dear Colleagues!  This is Asrar Qureshi’s Blog Post #754 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on  WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here. Photo Credit: Artem Podrez Photo Credit: Nandhu Kumar USFDA maintains that currently available data for Pfizer-BioNTech and Moderna vaccines shows that the vaccines are safe by and large. A CDC study published in Lancet Infectious Diseases says that self-reported data was reviewed by the researchers. Patients were advised to report adverse events on two systems: VAERS – Vaccine Adverse Event Reporting System, and v-safe tracker. Of the 340,522 reports made to VAERS, 92% were non-serious, 6.6% were serious, and 1.3% were deaths. The most common adv...