Thalidomide, sold under the brand name Immunoprin, among others, is an immunomodulatory drug and the prototype of the thalidomide class of drugs. Today, thalidomide is used mainly as a treatment of certain cancers (multiple myeloma) and of a complication of leprosy.
Thalidomide was first marketed in 1957 in West Germany under the trade name Contergan. The German drug company Chemie Grünenthal developed and sold the drug. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure “anxiety, insomnia, gastritis, and tension”.
Alleviate Morning Sickness
Afterwards, it was used against nausea and to alleviate morning sickness in pregnant women.
Thalidomide became an over-the-counter drug in West Germany on October 1, 1957. Shortly after the drug was sold in West Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs). Only 40% of these children survived.
Infants with Phocomelia
Throughout the world, about 10,000 cases were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived.
Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps.
Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and deafness.
The negative effects of thalidomide led to the development of more structured drug regulations and control over drug use and development.
What GMP lessons can we learn from this?
Again, this was a GMP deficiency by not having adequate QA and QC programmes.
The presence of the unwanted molecules could have been detected using a validated assay.
The solution would have been to remove the undesired molecule by a validated
purification process and assured by using a validated testing procedure which would have ensured a greater certainty of prevention and detection of bad product before it was released to market.