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Questions and Answers
What event is considered to mark the beginning of modern pharmacovigilance?
What event is considered to mark the beginning of modern pharmacovigilance?
- The withdrawal of thalidomide from the market
- The unjustified claims of safety in pregnancy for thalidomide (correct)
- The testing and development of medicines outside the USA
- The use of pharmaceutical companies in drug regulation
What is the significance of thalidomide in the history of drug safety?
What is the significance of thalidomide in the history of drug safety?
- It caused a significant increase in environmental pollution
- It was the first drug to be regulated by the FDA
- It led to the recognition of the need for pharmacovigilance (correct)
- It was widely used in the USA for treating pregnant women
Which country was particularly affected by thalidomide's teratogenic effects?
Which country was particularly affected by thalidomide's teratogenic effects?
- Australia
- USA
- UK
- Germany (correct)
What was the initial cause thought to be for the major increase in birth defects in Germany?
What was the initial cause thought to be for the major increase in birth defects in Germany?
When was thalidomide finally recognized as a problem and withdrawn from sale?
When was thalidomide finally recognized as a problem and withdrawn from sale?
What was the main problem associated with the use of thalidomide?
What was the main problem associated with the use of thalidomide?
Who initially made unjustified claims of safety in pregnancy regarding thalidomide?
Who initially made unjustified claims of safety in pregnancy regarding thalidomide?
Which country first marketed thalidomide and was particularly affected by the teratogenic effects?
Which country first marketed thalidomide and was particularly affected by the teratogenic effects?
What caused a major increase in the incidence of phocomelia, a rare congenital abnormality, in Germany?
What caused a major increase in the incidence of phocomelia, a rare congenital abnormality, in Germany?
What event is considered to mark the beginning of modern pharmacovigilance?
What event is considered to mark the beginning of modern pharmacovigilance?
Flashcards
Thalidomide Tragedy
Thalidomide Tragedy
The event that marked the beginning of modern pharmacovigilance. Thalidomide, a drug initially marketed for morning sickness, was found to cause severe birth defects.
Pharmacovigilance
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.
Teratogenic Effects
Teratogenic Effects
Harmful effects of drugs on a developing fetus, leading to birth defects.
Phocomelia
Phocomelia
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What caused the Thalidomide Tragedy?
What caused the Thalidomide Tragedy?
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Why is Thalidomide important?
Why is Thalidomide important?
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Where was Thalidomide mostly used?
Where was Thalidomide mostly used?
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Early Theories about Phocomelia Increase
Early Theories about Phocomelia Increase
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When was Thalidomide withdrawn?
When was Thalidomide withdrawn?
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Who was responsible for Thalidomide's safety claims?
Who was responsible for Thalidomide's safety claims?
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Study Notes
Modern Pharmacovigilance and Thalidomide
- The thalidomide tragedy is recognized as a pivotal event that shaped the field of modern pharmacovigilance.
- Thalidomide was marketed in the late 1950s as a sedative and treatment for morning sickness during pregnancy.
Significance of Thalidomide
- Thalidomide is infamously known for causing severe teratogenic effects, particularly resulting in limb deformities in newborns.
- It highlighted the urgent need for stricter drug safety regulations and surveillance systems.
Affected Countries
- Germany experienced a significant impact, with thousands of babies born with phocomelia, a condition characterized by shortened or absent limbs.
Initial Causes and Misconceptions
- Initially, the rise in birth defects in Germany was falsely attributed to environmental factors rather than the use of thalidomide.
- The drug's safety was initially endorsed by pharmaceutical companies and some medical professionals, leading to its widespread use.
Recognition and Withdrawal
- Thalidomide was officially recognized as harmful and withdrawn from sale in 1961 after growing evidence linked it to birth defects.
Main Problems
- The primary concern surrounding thalidomide was its teratogenic effects, which caused devastating congenital disabilities in infants when taken by pregnant women.
Disputed Safety Claims
- Manufacturers of thalidomide made unfounded claims about the drug’s safety for pregnant women, contributing to widespread prescriptions.
Marketing and Impact
- Thalidomide was first marketed in Germany, leading to the severe consequences that followed due to its teratogenic properties.
Increased Incidence of Phocomelia
- The widespread use of thalidomide among pregnant women in Germany resulted in a significant rise in phocomelia cases during the late 1950s and early 1960s.
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