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Origins of Thalidomide/How it Came to be

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Origins of Thalidomide/How it Came to be

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-Thalidomide was introduced as a sedative and treatment for morning sickness in pregnant women during the late 1950s and early 1960s.

-In an attempt to create a more secure sedative than those currently in use. Thalidomide was thought to promote sleep without producing respiratory depression, which was a common effect of other sedatives at the time, thalidomide was first seen as promising.

-The chemical formula for thalidomide is C₁₃H₁₀N₂O₄.

-Thalidomide was initially created in the late 1950s and early 1960s by the German pharmaceutical company Chemie Grünenthal.

- It was originally made available on the West German market in 1957 as a sedative and anti-nausea drug.

-Thalidomide was soon commercialized in many nations throughout the world as a result of its perceived safety and efficiency, which helped it gain popularity.

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-The sudden spurt in babies with a variety of deformities put the world on notice. Scientists discovered that along with this came the new tranquilizer thalidomide. Women who had taken this drug during their pregnancy would result in several deformities.

-Thalidomide caused birth defects and limb abnormalities in newborn children. This would happen to mothers who had taken the drug during pregnancy.

-This caused a condition known as phocomelia, which made the hands or feet attached close to the trunk, the limbs being very underdeveloped or absent. This condition was a side effect of the drug thalidomide taken during early pregnancy.

-Thalidomide also had many neurological effects and damage to the brain, leading to development and behavioral issues.

-The "Thalidomide Disaster" put the FDA on heavy notice. This prompted stricter regulations for the approval of new medicines and drugs, especially during pregnancy.

-40 years later over 10,000 people are affected by this worldwide.

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1. Chemie Grunenthal (Manufacturer):

-Chemie Grünenthal marketed thalidomide as a safe and effective sedative for various conditions, including morning sickness in pregnant women.

-Chemie Grünenthal faced severe criticism for its role in the thalidomide tragedy. The company eventually withdrew the drug from the market and faced legal action.

2. Health Regulators:

- Health regulators both in Germany and globally were tasked with responsibly approving and monitoring the safety of drugs. The thalidomide incident led to stricter regulations in the pharmaceutical industry.

-More rigorous testing and approval process for new drugs. Especially when it comes to ensuring the safety of a drug when taking it during pregnancy.

3. Affected Families and Individuals:

-Individuals and families affected by thalidomide faced significant hardships due to the severe birth defects caused by thalidomide. They seek justice and compensation for the people who were affected.

-Affected families took legal action against Chemie Grünenthal to seek compensation for all the damage they have done. This also played a role in awareness of the risks of certain medications during pregnancy.

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-More than 10,000 thalidomide-impaired babies were born worldwide and about 40% of them died before their first birthday. It is estimated that about 5,000 survived childhood.

-In Germany a criminal trial of executives of Grünen-

thal was opened in 1968. The case was that ‘they had put

on sale of a drug that caused an unacceptable degree of

bodily harm without having tested it properly.

-By the end of 1970, the proceedings of the trial were

suspended for good.

- In 1971, the Foundation for Handicapped Children

was established by the German government. The founda-

time was set up to design a compensation scheme funded

by the money Grünenthal had agreed to contribute

and by additional financial support provided by the Fed-

eral Government. A total of 2,866 thalidomide victims

were finally covered by the scheme and by the early 1990s

more than 500 million DM (about 255,646,000 EUR) had

been paid.

-40 years later 10,000 people are still affected world wide.

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40 Years Later

FDA Regulations

Thalidomide: A Twenty-Five-Year Perspective

The History of Thalidomide

"Thalidomide Disaster"

The Redemption of Thalidomide: Standardizing the Risk of Birth Defects

Brief History of U.S. Pharmaceutical Regulation

Defects And Disabilities Of Thalidomide Children