Thalidomide is a drug from the class of sedatives. It led to the thalidomide scandal due to damage to unborn children.
What is thalidomide?
Thalidomide is a drug from the class of sedatives. It led to the thalidomide scandal by causing damage to unborn children. The active ingredient thalidomide, also known as α-phthalimidoglutarimide, was formerly prescribed as a sleeping pill and sedative. It was developed in the 1950s at the Grünenthal pharmaceutical company in Stolberg. The active ingredient thalidomide accounted for almost half of Grünenthal’s German sales in the 1960s. According to Grünenthal’s research results, non-pregnant rats and mice did not show any pathological reactions. Even high doses caused neither fatal reactions nor side effects in animal experiments. As a result, the active ingredient was classified as non-toxic. From October 1957 to November 1961, Grünenthal marketed the active ingredient under the name thalidomide as a sedative and sleeping pill with virtually no side effects. Thalidomide was even recommended as the drug of choice for pregnant women with sleep disorders in the late 1950s. A short time later, the so-called thalidomide scandal broke, as the number of malformed newborns increased. It became clear at the beginning of 1959 that the damage was due to the ingestion of the active ingredient thalidomide. Nevertheless, thalidomide continued to be marketed until November 1961. There are around 4,000 thalidomide victims throughout Germany. Thalidomide has been approved for the treatment of multiple myeloma in Germany since 2009.
Pharmacologic effect
Thalidomide is a derivative of glutamic acid and belongs to the group of piperidinediones. These are structural modifications of barbiturates. The active ingredient has a sedative effect and promotes sleep. Anti-inflammatory properties have also been demonstrated. The active ingredient blocks the growth factor VEGF. By inhibiting this vascular endothelial growth factor, the formation of blood vessels is inhibited.
Medical application and use
Due to the thalidomide scandal, thalidomide is of course no longer approved as a sleeping pill or sedative. In Germany, however, the drug is used to treat multiple myeloma. Multiple myeloma, also known as Kahler’s disease, is a malignant disease that belongs to the B-cell lymphomas and is characterized by a proliferation of plasma cells in the bone marrow. In the United States, thalidomide is also used to treat the infectious disease leprosy. Other indications for the use of thalidomide include various skin and autoimmune diseases. In particular, children and adolescents with Crohn’s disease have shown an improvement in symptoms due to the immunomodulatory effect of the drug. The dispensing of thalidomide in Germany is regulated by a paragraph of the German Drug Prescription Regulations (Arzneimittelverschreibeordnung). Drugs with the active ingredient thalidomide are only available with a T-prescription. The T-prescription is a prescription form that is only used to prescribe thalidomide. Furthermore, patients must provide written assurance that they are using contraception while taking thalidomide.
Risks and side effects
If thalidomide is taken within the first three months of pregnancy, severe malformations occur in unborn babies. In particular, the extremities are affected. Limbs and organs may be completely absent. Klumphand is one of the typical dysmelia that can be caused by thalidomide. It is manifested by a shortened arm and a forearm that is bent inward or outward. Whole bones may also be missing. The reason for these malformations is the inhibition of Vascular Endothelial Growth Factor. The lack of blood vessel formation in the extremities of the unborn child results in shortened or completely missing arms and legs. On the basis of examinations, it can be proven quite precisely which damage is caused at which point in the pregnancy. If taken between the 34th and 37th day of pregnancy, for example, there is a missing auricle. If taken between the 38th and 45th day after menstruation, children develop arm malformations. Leg malformations develop between the 41st and 47th day. Initially, it was feared that thalidomide would also damage the genetic material and that the damage would thus be passed on to subsequent generations.However, this fear has not been realized. However, thalidomide can also have side effects outside of pregnancy. For example, some patients develop polyneuropathy while taking thalidomide. There may also be an increased risk of malignant transformation.
