THALIDOMIDE

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THALIDOMIDE

• Thalidomide (Contergan) - 1956 -therapy of nausea
  of pregnant women
• 28 countries - 100 000 kg of thalidomide, 10.000
  children - fokomelie
• teratogenic dose in man is very low (0,1 mg/kg)
• tested animal species - 20-300 mg/kg
• only one dose 50-100 mg in critical period of
  pregnancy (21.-36. day)

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Pregnancy risk categories - FDA

• Category A Controlled human studies have
  demonstrated no fetal risk - levothyroxin
• Category B Animal studies indicate no fetal
  risk, but no human studies OR adverse effects in
  animals , but not in well-controlled human
  studies - paracetamol
• Category C No adequate human or animal
  studies.OR adverse fetal effects in animal
  studies, but no available human data. -
  theophyllin, amlodipin
• Category DEvidence of fetal risk, but benefits
  outweigh risks. - beta-blockers, ACEI
• Category X Evidence of fetal risk. Risks
  outweigh any benefits. - oral contraceptives,
  statins

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