Thalidomide tragedy – the turning point in monitoring of drug reactions
In 1956, a drug with a hypnotic and sedative effect was marketed in Germany, with thalidomide as the active substance. Due to its effects, it was especially used by pregnant women to treat insomnia, morning sickness, and vomiting.
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.
Lucija Bedeniković, MPharm / Senior Pharmacovigilance Associate
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Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)