Pharmacovigilance remind that patent safety

 😊Hello Everyone,

For all the freshers stepping into Pharmacovigilance, it's very important to know about the historical incident "The Thalidomide Tragedy", which changed the face of drug safety forever.

💡What happened?

In the late 1950s, Thalidomide was introduced as a sedative and treatment for morning sickness in pregnant women. Unfortunately, it was not tested on pregnant animals before approval. As a result, thousands of babies were born with severe birth defects (limb deformities, organ damage).

💡Reason for the tragedy

➡️Lack of proper clinical trials

➡️Absence of testing in pregnant animals

➡️Weak regulatory requirements for drug approval at that time

💡Changes after the tragedy

➡️Strict drug regulations  implemented globally

~Mandatory animal studies, including reproductive toxicity studies

~More rigorous clinical trial phases before drug approval

~More rigorous clinical trial phases before drug approval

~Establishment of Pharmacovigilance systems to continuously monitor drug safety even after marketing

✨ The main mistake was failure to test on pregnant animals, which highlighted the importance of preclinical safety studies.

👉This event is the foundation of modern Pharmacovigilance a reminder that "patient safety "always comes first.

~Establishment of Pharmacovigilance systems to continuously monitor drug safety even after marketing

+ The main mistake was failure to test on pregnant animals, which highlighted the importance of preclinical safety studies.

This event is the foundation of modern Pharmacovigilance a reminder that "patient safety "always comes first.