Thalidomide re-approval

General
1

From Tragedy to Therapeutic Triumph: The Story of Thalidomide’s Re-Approval

:pill: Thalidomide is a name etched in medical history for one of the worst drug safety tragedies of the 20th century.
Originally launched in the 1950s as a sedative & antiemetic for pregnancy, it caused widespread birth defects :baby::cross_mark:, leading to its global withdrawal.

:microscope: But science didn’t stop there. With rigorous research, strict regulations, and controlled programs, Thalidomide has been re-approved for specific indications under careful monitoring.

:white_check_mark: Current Approved Uses:

:drop_of_blood: Multiple Myeloma (in combination therapy)

:microbe: Erythema Nodosum Leprosum (ENL) – a painful complication of leprosy

:warning: Safety Note:
Due to its teratogenic potential :prohibited::pregnant_woman:, Thalidomide’s use is tightly regulated under special risk management programs (like REMS in the US) to prevent fetal exposure.

:light_bulb: Key Takeaways:

:counterclockwise_arrows_button: Drug safety is a continuous process, not a one-time approval.

:shield: Strong pharmacovigilance & regulatory frameworks are vital.

:seedling: Even a once unsafe drug may find new therapeutic life under the right safeguards.

pharmacovigilance #DrugSafety oncology Pharmacy clinicalresearch #MedicinalInsights

MBH/AB

2 Likes
2

It’s really surprising how thalidomide, once linked to such a big tragedy, is now saving lives in cancer and leprosy under strict monitoring. This shows how drug safety isn’t a one-time process but a continuous journey. With strong regulations and pharmacovigilance, even a drug once unsafe can find a safe therapeutic use.

3

Wow , once a tragedy now life saving.
Even though there are side effects every drug do have nice positive side.

4

True, thalidomide’s journey highlights the importance of pharmacovigilance. Its strict monitoring today ensures patients benefit in multiple myeloma and leprosy while minimizing risks.

5

Small actions, big impact on mental health.

6

Very informative.