Thalidomide Tragedy

General
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The Thalidomide Tragedy – A Turning Point in Pharmacovigilance
:black_small_square: 1957 – Thalidomide was first marketed in West Germany as a sedative and treatment for morning sickness in pregnant women.
:black_small_square: Late 1950s – Early 1960s – Widely prescribed in Europe, Asia, Africa, and other regions.
:backhand_index_pointing_right: At the time, drug safety regulations were not as strict as they are today.

The consequences were:
:warning: Over 10,000 children were born with severe birth defects, particularly
limb deformities (Phocomelia- A rare condition)
:warning: Many more pregnancies ended in miscarriages and stillbirths.
:warning: Other deformities like ear, heart, and organ malformations.

:right_arrow: Immediate Action – The drug was withdrawn from markets worldwide.

This tragedy became a wake-up call for the world. It led to:
:check_mark: Stricter drug approval processes.
:check_mark: Establishment of global pharmacovigilance systems.
:check_mark: A culture of continuous safety monitoring.

Interestingly, thalidomide was later reintroduced under strict controls for the
leprosy and multiple myeloma Condition.
The actual pharmacovigilance starts after thalidomide tragedy.
The thalidomide incident reminds us why drug safety can never be taken for granted.

MBH/PS

1 Like
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yes heard about this in college

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Being a pharma student there’s no way that i didn’t know this. we have read about it in our pharmacology and i still remember the image of the babies who are born deformed in K.D.Tripati book. Thanks for sharing this.

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This incident really changed the drug regulation policies over the time. This is why when developing drugs it is important to choose safety over speed.

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A dark lesson from medical history: Thalidomide was once touted as a safe treatment for morning sickness but tragically caused birth defects in over 10,000 babies by disrupting early limb development.

It shocked the world and led to sweeping changes in how we test drugs like requiring safety checks in pregnant animals and stricter regulations for approval.

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A dark fact about drug safety is the thalidomide tragedy, which emphasizes the need for conducting trials to ensure safety, efficacy, and pharmacovigilance even after a drug is on the market.