Thalidomide tragedy – the turning point in monitoring of drug reactions

How it all began

As it could be obtained without a prescription, the drug was available to a large number of people. The drug itself had not been tested in pregnant women: moreover, it had not been tested in humans at all, but only in animals (mice and rats). It was not considered harmful; only its acute toxicity was evaluated, but not chronic toxicity, which means that the drug’s effect on the foetus had not been studied.

First signs of disaster

By 1960, thalidomide had become the best-selling sedative in Germany, and its use spread to the rest of the world. However, already the following year (1961) saw an increase in the number of children born with deformities whose mothers used thalidomide during pregnancy. In total, approximately 12 thousand children with severe malformations were born. Some of the malformations include missing limbs or ears, facial deformities, and severe internal organ defects. Tens of thousands of newborns died from various metabolic disorders.

This is known as the thalidomide tragedy, and is justifiably considered the biggest medical disaster caused by a pharmaceutical in history.

Turning point in the monitoring of drug reactions

This event is also considered the turning point in understanding the risks associated with taking medications, and the method of assessing the safety of medicinal products and their side effects. It was only after the thalidomide tragedy that studies on the effect of drugs on foetal development began. It should be noted that this scenario did not occur in the US because the marketing of thalidomide had not been authorised there due to incomplete drug safety data.

Owing to the consequences caused by thalidomide use, the myth of medications without harmful effects was destroyed forever, and more and more attention started to be paid to side effects. Although it is unquestionable that the thalidomide tragedy is horrendous, its occurrence is nonetheless responsible for the improvement of drug safety evaluation, as well as for the development of pharmacovigilance itself.

Pharmacovigilance aims to ensure patient protection and safe drug use: Marti Farm has many years of experience and knowledge precisely in this area. In addition, as a reliable partner Marti Farm ensures comprehensive coverage of regulatory services in the field of pharmacovigilance by regular monitoring of regulations, and prompt adjustment of its system to all necessary changes. Pharmacovigilance regulations are among the strictest in the world, but Marti Farm has proven itself through numerous audits that it has a superbly implemented system which can meet such rigorous requirements effortlessly and efficiently. If you would like to work with top pharmacovigilance experts who undergo timely and continuous education and training, connect with us.