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  1. 1. Thalidomide<br />Jessica <br />
  2. 2. What is Thalidomide?<br />Thalidomide is a sedative-hypnotic and multiple myeloma medication. The drug is a potent teratogen in rabbits and primates including humans: severe birth defects may result if the drug is taken during pregnancy. Formula for thalidomide is C13H10N2O4.<br />
  3. 3. History of thalidomide<br />They say that Thalidomide was developed by Germans in <br />the pharmaceutical company Grünenthal in Stolberg but <br />some people say that this claim has been canceled. Dr. <br />Martin W Johnson, who is the director of Thalidomide Trust <br />in the United Kingdom, showed evidences that Thalidomide <br />was developed as an antidote to nerve gases. Some nerve <br />gases are sarin. Others say the drug was synthesized by <br />British scientists. They found that Thalidomide was found to <br />be an effective tranquilizer and painkiller and was <br />proclaimed a "wonder drug" for insomnia, coughs, colds <br />and headaches. It was also found to be an effective <br />antiemetic which had an inhibitory effect on morning <br />sickness, and so thousands of pregnant women took the <br />drug to relieve their symptoms.<br />
  4. 4. Birth defects<br />In Europe and Canada during the early 1960s, thalidomide was prescribed to treat morning <br />sickness in pregnant women. At that time, it was not approved in the United States because Dr. <br />Frances Kelsey from the Food and Drug Administration (FDA) stated there was insufficient proof of <br />the drug’s safety in humans. Thalidomide was soon banned worldwide when it was discovered that it <br />caused tragic birth defects. According to the March of Dimes (MOD, November 1998), "More than <br />10,000 children around the world were born with major malformations, many missing arms and legs, <br />because their mothers had taken the drug during early pregnancy. Mothers who had taken the drug <br />when arms and legs were beginning to form had babies with a widely varying but recognizable pattern <br />of limb deformities. The most well-known pattern, absence of most of the arm with the hands <br />extending flipper-like from the shoulders, is called phocomelia. Another frequent arm malformation <br />called radial aplasia was absence of the thumb and the adjoining bone in the lower arm. Similar limb <br />malformations occurred in the lower extremities. The affected babies almost always had both sides <br />affected and often had both the arms and the legs malformed. In addition to the limbs, the drug caused <br />malformations of the eyes and ears, heart, genitals, kidneys, digestive tract (including the lips and <br />mouth), and nervous system. Thalidomide was recognized as a powerful human teratogen (a drug or <br />other agent that causes abnormal development in the embryo or fetus). Taking even a single dose of <br />thalidomide during early pregnancy may cause major birth defects."<br />1962 photo of a baby born to a mother who had taken Thalidomide while pregnant; note the extra appendage connected to the foot and the malformation of the right arm.<br />
  5. 5. UNITED STATES PRESCRIBING THALIDOMIDE <br />On July 16, 1998, the FDA approved the use of thalidomide for the treatment of <br />lesions associated with Erythema Nodosum Leprosum (ENL). Because of <br />thalidomide’s potential for causing birth defects, the distribution of the drug was <br />permitted only under tightly controlled conditions. The FDA required that Celgene <br />Corporation, which planned to market thalidomide under the brand name <br />Thalomid, establish a System for Thalidomide Education and Prescribing Safety <br />(S.T.E.P.S.) oversight program. For safety the pregnancy teat women who were <br />prescribed thalidomide. <br />
  6. 6. United Kingdom`s view on prescribing thalidomide<br />Thalidomide is available to only a small number of patients in the <br />UK, generally in specialist cancer treatment centers, where <br />research trials are taking place and specialist doctors have <br />experience in its use.<br />
  7. 7. BRAZIL PRESCRIBING THALIDOMIDE <br />Brazil has the second highest prevalence rate of leprosy in the world and <br />thalidomide has been used by Brazilian physicians as the drug of choice <br />for the treatment of severe ENL since 1965. A study published in 1994 <br />found 61 people born after 1965 whose limb defects and exposure history <br />were compatible with thalidomide embryopathy. In 63.6% of these cases, <br />thalidomide had been prescribed without the physician informing the <br />patient about the drug's teratogenicity. Since then production, dispensing <br />and prescription of thalidomide have been strictly controlled and cases <br />of thalidomide embryopathy are thought to have occurred until today<br />
  8. 8. Full list of indications currently being investigated in clinical trials<br />Amyotrophic lateral sclerosis <br />Aphthous ulcer<br />Behcet's syndrome <br />Brain cancer<br />Breast cancer <br />Cachexia<br />Colorectal cancer <br />Congestive heart failure <br />Crohn's disease<br />Diarrhea<br />Fibrodysplasiaossificansprogressiva<br />Graft-versus-host disease <br />Haematological malignancy<br />HIV infection<br />Hodgkin's Diseases<br />Kaposi's sarcoma<br />Leukaemia<br />Macular degeneration <br />Malignant melanoma <br />Mycobacterium avium complex infections <br />Myelodysplastic syndrome <br />Myelofibrosis<br />Myeloid leukaemia<br />Non-Hodgkin's lymphoma <br />Non-small cell lung cancer<br />Ovarian cancer<br />Pain<br />Prostate cancer<br />Prurigonodularis<br />Renal cancer<br />Rheumatoid arthritis <br />Small cell lung cancer <br />Systemic lupus erythematosus<br />Thyroid cancer<br />Tuberculosis<br />Thalidomide is still used today. Doctor`s are trying to see if the drug will help cure cancer and other illness. Thalidomide stopped a certain development in the womb, so they think that it might help stop cancer and other Illness in a certain stage of developement<br />
  9. 9. Side affects of thalidomide <br />Sleepiness<br />Constipation<br />skin rash<br />severe headaches<br />stomach aches<br />peripheral neuropathy (numbness and pain in your arms, hands, legs and feet)<br />Dizziness<br />Nausea<br /> giddiness or nervousness at higher doses <br />shivering and buzzing in the ears<br />depression or mood-swings<br />severe birth defects <br />
  10. 10. Louise MedusMansell<br />Louise MedusMansell is 48 years old and was born in 1962. Lousie<br />fathers name is David Mason. Her mother was prescribed thalidomide <br />during pregnancy. She was born with shorten arms and legs. Not long <br />after birth Louise was placed in a home for disabled children in Kent. Her <br />parents were told that Louise was only going to live for a few weeks. <br />Louise first married in 1987 to John. They had two children together and <br />they separated in 1994. She then remarried in August 2008 to Darren <br />Mansell who is 49 years old. They dated as children and he is also a <br />thalidomide victim. <br />
  11. 11. Thomas Quasthoff<br />Thomas Quasthoff was born November 9, 1959 in Hildesheim, Germany. <br />He was born with serious birth defects due to his mother`s exposure to <br />the drug thalidomide during pregnancy. She was prescribed thalidomide <br />as an antiemetic to combat her morning sickness. Thomas is short due to <br />shortening to the long bones in the legs and he had phocomelia of the <br />upper extremities with very short or absent long bones and flipper-like <br />appearance of his hands. He is four foot tall. Thomas is a musician and <br />has been denied admission to the music conservatory.<br />
  12. 12. David Lega<br />David Lega was born in 1973 in Gothenburg, Sweden. <br />He was born with AMC, a serious disability which<br />means he was paralyzed in both arms and lacked <br />muscles in his legs.<br />
  13. 13. Mat Fraser <br />Mat was born in 1962 in England, UK. Mat Fraser was <br />born with phocomelia of both arms, due to his mother <br />being prescribed thalidomide during her pregnancy<br />
  14. 14. Terry Wiles<br />Terrence 'Terry' Wiles was born in Peterborough, <br />Cambridgeshire, England on January 12, 1962. Andrew <br />(as he was originally named) was one of the most <br />disabled thalidomide babies born in the UK. His mother <br />had morning sickness so the Germany prescribed her <br />thalidomide. This caused Terry to have birth defects.<br />Terry as a child.<br />
  15. 15. Niko von Glasow <br />Niko von Glasow was born in 1960 in Cologne <br />Germany. He is the son of Ernst Brücher and Majella <br />Neven DuMont. He`s mother also took thalidomide <br />During her pregnancy and it caused her son to have<br />birth defects.<br />
  16. 16. Dr. Kelsey<br />Frances Kathleen Oldham Kelsey, Ph.D., M.D., (born 24 July 1914) is a Pharmacologist. <br />most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who <br />refused to authorize thalidomide for market because she had concerns about the drug's <br />safety. Her concerns proved to be justified when it was proven that thalidomide caused <br />serious birth defects. Kelsey's career intersected with the passage of laws <br />strengthening the FDA's oversight of Pharmaceuticals. In the 1960s, Kelsey prevented <br />the marketing of thalidomide in the U.S. through her insistence on credible proof <br />of its safety. <br />
  17. 17. Resources<br /><br /><br /><br /><br /><br /><br /><br /><br />