The Thalidomide tragedy is one of the most notorious episodes in the history of medicine and pharmaceutical regulation. Thalidomide, initially introduced as a seemingly safe and effective medication, led to a public health crisis with severe and lasting consequences. Here's an overview of the Thalidomide tragedy

1. Welcome
Thalidomide Tragedy
Name : Kothapally Vaishnavi
Qualification : B.Pharmacy
Student ID : 233/122023
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2. Index
Introduction
Historical Context
Medical Usage
Unintended Consequences
Regulatory Response
Ethical Considerations
Conclusion
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3. Introduction
 Thalidomide, initially developed in the late 1950s, was marketed as a revolutionary
pharmaceutical breakthrough.
 Introduced as a sedative and antiemetic (anti-nausea) medication, it gained widespread
popularity and trust among healthcare professionals.
 Its primary intended use was to alleviate symptoms associated with insomnia, anxiety, and morning sickness in pregnant
women.
 Marketed under various brand names in the late 1950s and early 1960s, Thalidomide was hailed as a safe and effective
solution for these common health issues.
 The use of thalidomide in 46 countries by women who were pregnant or who subsequently became pregnant resulted in
the "biggest man-made medical disaster ever," with more than 10,000 children born with a range of severe deformities,
such as phocomelia, as well as thousands of miscarriages.
 Its antiangiogenic effects were unknown prior to its release for human use.
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4. Historical Context
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5. Medical Usage
Treatment of Multiple Myeloma
Thalidomide has been approved
for the treatment of multiple
myeloma, a type of cancer that
affects plasma cells in the bone
marrow. It is often used in
combination with other
medications.
Management of leprosy-related
complications
Thalidomide has demonstrated
efficacy in treating complications
associated with leprosy, such as
erythema nodosum leprosum
(ENL), a painful skin condition.
.
Antiangiogenic Properties
Thalidomide has antiangiogenic
properties, meaning it can inhibit
the formation of new blood
vessels. This property has been
explored in the treatment of
certain cancers and conditions
where angiogenesis plays a role.
Behcet's Disease
Thalidomide has been
investigated for its effectiveness in
treating Behçet's disease, a rare
autoimmune disorder that causes
inflammation in blood vessels.
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6. Unintended Consequences
The unintended consequences of thalidomide use include.
 Teratogenic Effects
 The most notorious consequence of thalidomide was its
teratogenic effects, leading to severe birth defects in infants
whose mothers took the drug during pregnancy.
 These birth defects included limb abnormalities, such as
phocomelia (malformation of limbs), as well as defects in
the eyes, ears, and internal organs.
 Impact on Offspring
 Thousands of babies worldwide were born with thalidomide-related birth defects.
 Many of them experienced significant challenges in their daily lives due to physical disabilities,
requiring extensive medical care, rehabilitation, and support.
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7. Regulatory Response
The thalidomide tragedy, regulatory agencies around the world implemented significant changes to drug approval and
monitoring processes to prevent similar incidents from happening in the future.
Here are some of the key regulatory responses.
 Strengthened Drug Approval Process
 The thalidomide incident highlighted the need for more rigorous testing of drugs, especially those intended for use
during pregnancy.
 Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency
(EMA), implemented stricter criteria for the approval of new drugs, particularly in terms of safety testing, especially
during pregnancy.
 Introduction of Preclinical Testing
 Regulatory agencies began to emphasize the importance of preclinical testing, including animal studies, to assess the
potential risks of new drugs before they are tested in humans.
 Thorough evaluation of a drug's effects on various systems became a standard part of the drug approval process.
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8. Regulatory Response
 Pharmacovigilance and Post-Marketing Surveillance
 The thalidomide tragedy underscored the importance of ongoing monitoring of drugs after they have been approved
and are on the market.
 Pharmacovigilance systems were established or strengthened to detect and respond to adverse drug reactions
promptly.
 Informed Consent and Patient Information
 There was an increased emphasis on informed consent and providing patients with comprehensive information about
the potential risks and benefits of medications.
 This aimed to ensure that individuals could make informed decisions about their healthcare, especially in the case of
pregnant women.
 Focus on Teratogenicity Testing
 The thalidomide tragedy led to increased attention on teratogenicity testing, which assesses the
potential of a drug to cause birth defects.
 This became a critical component of drug development and approval processes.
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9. Ethical Considerations
 Inadequate Testing and Regulation
 Thalidomide was inadequately tested for its effects on pregnant women and their unborn children.
 This highlights the importance of rigorous testing and regulatory oversight before new drugs are brought to market.
 Lack of Informed Consent
 Pregnant women who took thalidomide were often not adequately informed about the potential risks to their unborn
children.
 Informed consent is a fundamental ethical principle in medical research and treatment, and its absence in this case is
a serious ethical violation.
 Delayed Response
 There was a delayed response in withdrawing thalidomide from the market even after reports of birth defects
emerged.
 This delay raises ethical questions about the balance between business interests and public health, as the safety of
patients should always be the top priority.
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10. Conclusion
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 The thalidomide tragedy had a profound and lasting impact on the pharmaceutical
industry and drug regulation.
 While it resulted in immeasurable suffering for those affected, it also prompted
crucial changes in policies and practices to prevent similar incidents from occurring
in the future.
 The lessons learned from thalidomide continue to shape the way drugs are
developed, tested, and approved, emphasizing the paramount importance of ensuring
the safety of patients, especially vulnerable populations such as pregnant women and
their unborn children.

11. Thank You!
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