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Thalidomide and fda history ppt

    One of the most pivotal moments in FDA's history occurred during the 1960s with the Thalidomide tragedy.
Thalidomide was originally developed in the s as a sedative drug but was withdrawn from the market after being linked to severe birth defects. It is now approved to treat certain cancers and inflammatory diseases. The document outlines the history, chemistry, pharmacokinetics, adverse effects, and current uses of thalidomide.
    Thalidomide was first developed by CIBA, a Swiss pharmaceutical company in the early 1950s, and subsequently introduced as Contergan by.
Thalidomide is a sedative that caused severe birth defects in the s when prescribed to pregnant women for morning sickness. It was discovered to be a potent teratogen, causing babies to be born with phocomelia (flipper-like limbs) and other malformations.
    Drug is FDA approved for ENL; Changes body's immunological and Suffer the Children: The Story of Thalidomide.
1. History of Thalidomide: Harmful effects that lead to the ban in 2. Structure of Thalidomide: Chemical make up and chirality/enantiomer issue that led to problems. 3. Thalidomide makes a comeback in with the approval by the FDA: current uses of the drug. 4.


    Thalidomide uses

As the drug was traded under so many different names in 49 countries, it took five years for the connection between thalidomide taken by pregnant women and the impact on their children to be made. A UK Government warning was not issued until May

Thalidomide mechanism of action

Time for a change • FDA inspector Frances Kelsey, who prevented the drug’s approval within the United States was praised as a hero and received the President's Award for Distinguished Federal Civilian Service by John F. Kennedy. • The tragedy surrounding thalidomide helped motivate profound changes in the FDA.


  • thalidomide and fda history ppt

    • Thalidomide pharmacokinetics

  • Thalidomide Today. What was once the most feared drug in pharmaceutical armory could become one of its most valuable. Researchers look at the interactions that caused deformities to discover the safety of the drug in other uses; 15 Current Uses. Cancer treatment ; Inhibit tumors directly ; Drug will stop blood vessels from forming in and around.

    • Thalidomide tragedy pdf

    In thalidomide was licensed for treatment of one form of leprosy - ENL (Erythema Nodosum Laprosum) - amazingly effective and successful - WHO showed 99% of patients improved significantly - hailed as a wonder drug (again!).
  • thalidomide and fda history ppt3 5. The Elixir Tragedy, The US Food and Drug Administration’s role in the regulation of novel medicines was born out of tragedy. Seventy-one adults and 34 children died in the fall of after taking a drug called Elixir Sulfanilamide to treat a variety of ailments, from gonorrhea to sore throat.
  • Thalidomide‐induced teratogenesis: History and mechanisms The disaster prompted many countries to introduce tougher rules for the testing and licensing of drugs, such as the Kefauver Harris Amendment (U.S.), Directive 65/65/EEC1 (E.U.),and the Medicines Act (UK).In the United States, the new regulations strengthened the FDA, among other ways, by requiring applicants to prove efficacy and to disclose all side effects encountered in testing.
  • PPT - thalidomide PowerPoint Presentation, free download - ID ... Part one: History and Thalidomide Embryopathy. Thalidomide was released in the late 's as a nonaddictive, nonbarbiturate sedative by the German pharmaceutical company, Chemie‐Grunenthal (Fig. 1). Thalidomide was very effective and quickly discovered to also be an effective anti‐emetic and used to treat morning sickness in pregnant women.

    • Thalidomide generic name

      Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers (e.g., multiple myeloma), graft-versus-host disease, and many skin disorders (e.g., complications of leprosy such as skin lesions).


    Thalidomide and fda history ppt On this page, Grünenthal informs about the historical background of the thalidomide tragedy and the thalidomide trial.
    Thalidomide and fda history ppt presentation The FDA had 60 days to decide if the safety data supplied was adequate.
    Thalidomide and fda history Thalidomide makes a comeback in 1998 with the approval by the FDA: current uses of the drug.
    Thalidomide and fda history ppt template Unknown to FDA, the company had already distributed the thalidomide to 1,200 physicians in the United.
  • Thalidomide pharmacokinetics

    • Thalidomide ppt

    8. The Thalidomide Disaster In the late s and early s, more than 10, children in 46 countries were born with deformities such as phocomelia as a consequence of thalidomide use The Australian obstetrician William McBride and the German pediatrician Widukind Lenz suspected a link between birth defects and the drug They were later awarded a number of honors for this contribution In the.


    The thalidomide saga | PPT - SlideShare

    The Thalidomide tragedy is one of the most devastating events in the history of medicine and drug regulation. Thalidomide was a medication that was introduced in the late s and early s as a sedative and treatment for nausea during pregnancy. However, its use led to a widespread public health crisis with severe and tragic consequences.

    Thalidomide and fda history ppt1

    2. 2 History behind FDA Approval Thalidomide was introduced to the market by the company Chemie Grunenthal The first known victim, the daughter of a Grunenthal employee, was born The drug was banned worldwide after causing an estimated 10, birth defects Thalidomide was serendipitously discovered by Dr. Jacob Sheskin to treat complications associated with erythema.
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