Introduction
In the 20th century, Thalidomide first appeared in the market as a drug that was credited with many beneficial properties. Initially, it was introduced as a cure for seizures, but subsequently, it was prescribed for various ailments, including pregnant women suffering from insomnia, headaches, and nausea. An unexpected result was the mass birth of children with physical defects, which, in turn, caused fierce controversy regarding the admissibility of the drug. The lack of clinical data and confirmed evidence of negative effects on fetal development were key incentives to support claims against the medication.
History of Appearance
The first development of the drug began in the mid-1950s, and already in 1957, it was introduced to the market by a German pharmacological company. The medication was sent for sale in many countries of the world, but in the United States, a license for its distribution was never obtained. One of the reasons was the massive complaints from various patients regarding the birth of children with physical defects. The lack of clinical research was considered one of the key reasons for this tragedy.
Teratogenicity of the Drug
One of the key side effects of Thalidomide that explains the associated risks is teratogenicity, namely the effect on the genetic properties of the fetus in the early stages of pregnancy. Among the defects, missing limbs, facial muscle problems, and other severe health issues showed up in thousands of children whose mothers took Thalidomide. Although there is no definitive clinical data regarding similar risks when taking the drug in late pregnancy, the medication was heavily criticized.
General Contraindications
For the aforementioned reasons, Thalidomide is categorically contraindicated in pregnant women, as well as during the lactation period. Moreover, in women of childbearing age, taking this medicine must be accompanied by taking contraceptives. The drug is also dangerous as a medication that can lead to the development of skin diseases, such as dermatitis and epidermal necrolysis. This suggests that in the case of skin problems, Thalidomide is an undesirable drug. The ban on its adoption during pregnancy is due to proven teratogenic effects.
Associated Side Effects
Neuropathy, which is expressed in the loss of sensation in individual parts of the body, usually the limbs, can be a side effect of taking Thalidomide. Negative effects on the central nervous and cardiovascular systems can also be observed. Vessels can become clogged, which is a dangerous prerequisite for the development of tachycardia and other heart issues. Along with the aforementioned skin problems, genitourinary problems can worsen, and libido problems are potential side effects of taking the medication.
Details of the Effects of Thalidomide
From a scientific interpretation, embryopathy is a condition that develops in a pregnant woman while taking Thalidomide. Effects intensify in the period between 20 and 34 days after conception. The special protein Cereblon is susceptible to the dangerous impacts of the drug that destabilizes the protein complex of the fetus. Cells do not function normally, and therefore, mutations develop. Slowing down the proliferation of sensitive cells is a direct prerequisite for dangerous changes in the fetal body.
Sale Ban
The first formal proceedings began in the late 1960s, and the prosecution had sufficient grounds to bring the manufacturer of Thalidomide to criminal liability. Prosecutors insisted that the lack of clinical trials and the inadequate response to citizens’ appeals were the key factors indicative of the defendant’s guilt. Subsequently, for the victims of the medication, the German Ministry of Health organized a financial assistance fund, and disabled children began to receive payments.
Second Life of Thalidomide
After the high-profile scandal, Thalidomide disappeared from the pharmacological market for a while but soon reappeared. In the 1990s, it began to be prescribed as a remedy designed to fight neoplasms and leprosy. Clinical studies have proven the potential of Thalidomide to cure tuberculosis and prevent the development of AIDS in HIV-infected patients. However, the free sale of the drug is still not carried out in most developed countries, and strict contraindications for pregnant women have been preserved.
Clinical Research Based on Thalidomide
Detailed clinical studies of Thalidomide and medications similar in composition to this drug allow for addressing critical problems and are of high practical value. Firstly, scientists can better understand the protein degradation algorithm to avoid potential errors in the future and study how the corresponding changes affect living cells. Secondly, through this analysis, data can be obtained about useful and dangerous effects. This information can be utilized to create safe drugs, including for pregnant women, to secure their fetuses.
Conclusion
The analysis of the use of Thalidomide for pregnant women shows that the drug is categorically contraindicated in this population group, as evidenced by the tragic events of the mid-20th century associated with the birth of infants with physical defects. The violations committed by drug manufacturers had a wide public response and were considered at court hearings. Later, clinical studies of Thalidomide continued since research on the properties of this drug, namely the mechanisms of action on proteins, could be valuable for pharmacologists. However, the prescription of the medication to pregnant women is still prohibited.
Reference List
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- Vargesson N, Stephens T. Thalidomide: History, withdrawal, renaissance, and safety concerns. Expert Opinion on Drug Safety. 2021;20(12):1455-1457.
- de Jesus SM, Santana RS, Leite SN. Comparative analysis of the use and control of thalidomide in Brazil and different countries: Is it possible to say there is safety? Expert Opinion on Drug Safety. 2022;21(1):67-81.
- Malik S, Cohen PR. Thalidomide – Then and now: A case report of a woman with Thalidomide embryopathy and review of current Thalidomide uses. Cureus. 2021;13(8):e17070.