All about Thalidomide

Thalidomide is a medicine developed in Germany and used primarily as a sedative. Its use became a focus of controversy after being associated with malformations in the fetus when ingested by women in gestation.

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Thalidomide was discovered in 1954 by the German pharmaceutical company Chemie Grünenthal, during laboratory research aimed at finding new antibiotic drugs. In the process, the researchers eventually produced a substance called phthaloylisoglutamine, derived from glutamic acid and later called Thalidomide. However, it has been shown to have no applications as an antibiotic and has been tested on animals for effects on the body.

In laboratory tests Thalidomide has not been shown to have sedative or even anti-tumor effects when used on animals but, as well as having a very low toxicity index, scientists decided to test it on humans. These new tests showed that the new drug had a huge sedative capacity in people. This advantage, coupled with the fact that it is minimally toxic, caused Thalidomide to be launched on the German market in 1957 under the name Contergan®.

It was immediately widely used by women in pregnancy as a successful alternative to combat anxiety, insomnia and even the nausea characteristic of pregnancy. Since it was not necessary to have a prescription signed by a doctor to purchase the medicine, Thalidomide could be found under about 40 different denominations around the world.

Thalidomide Effects

The first reports of fetal malformation date back to the late 1950s. In 1960 the first studies were conducted on the basis of mothers and children with these determined malformations, discovering, through research, the relationship between these congenital problems and their use. Thalidomide. These events led to the withdrawal of the drug from the shelves in 1961, except in some countries such as Brazil, where its marketing was not interrupted until 1965.

Due to the severity of the disorders suffered by pregnant women and babies suffering from the effects of Thalidomide, the government of several countries, including Brazil, currently provides a monthly indemnity to anyone who can prove its consumption.

It is estimated that more than 10,000 children may have been affected by the drug, as well as countless abortions possibly caused by the drug.

Recently, thalidomide has been used again by doctors to treat lupus, leprosy, AIDS, Crohn's disease and some cancers, despite its proven harmful side effects. Researchers have been devoted to developing synthetic substances that offer the same healing potential for these problems without, however, the side effects.

Risks in pregnancy

Initially indicated to treat morning sickness, especially in the first three months of pregnancy, Thalidomide is considered the biggest disaster in medical history.

In humans, the process of limb formation and development is between the 4th and 9th weeks, or the 23rd and 55th days of pregnancy. The effects on the fetus are seen in pregnant women who have ingested even a single Thalidomide tablet between the 20th and 36th day of pregnancy.

Thalidomide Syndrome

Malformations may manifest as a complete absence of limbs (amelia), shortening of limbs (focomelia) or loss of fingers in less severe cases. In addition, the substance can cause hearing, visual problems, spinal and sometimes digestive tract defects. Some patients also have heart problems.

This set of symptoms the medical community calls Thalidomide Syndrome. However, naturally, for a person to be considered a carrier of the syndrome, it is necessary to prove the mother's ingestion of the drug during pregnancy.

Thalidomide Law

Pursuant to Law No. 7,070 of December 20, 1982, the Brazilian government is required to provide life support to Thalidomide victims. Such pension has its values ​​varying between half and four minimum wages, according to the degree of affectation. Factors taken into account for this calculation are diet, hygiene, ambulation and inability to work.

In 1994, Ordinance No. 63 was published, prohibiting the use of Thalidomide by any woman of childbearing age. Subsequently, in 1997, Ordinance No. 354 is published, regulating the production, registration, marketing, prescription and dispensation of products based on the substance.

On April 16, 2003, Law No. 10,651 was approved, which regulates the control of the use of Thalidomide in the national territory. Finally, in 2010, Law No. 12.190 is enacted, granting new compensation? this time for moral damages? victims of indiscriminate use of the drug.

For more information, access the Thalidomide package insert.

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