Thalidomide was a drug developed in Germany during the 1950’s by Chemie Grünenthal. Initially, the preparation was prescribed as a sedative or hypnotic, but later was it was used to combat nausea and morning sickness in expectant mothers.
Use of the medication by expectant mothers was not tightly controlled (scientists and clinicians did not believe drugs taken by the mother could pass through the placental barrier to the foetus) and in Germany, it became an over-the-counter medicine on 1 October 1957. Thalidomide was distributed under licence by 14 pharmaceutical companies in 46 countries under some 37 trade names including: Contergan, Distaval, Neurosedyn, Thalomid and Talidex.
An unexpected side effect of the drug was that it caused phocomelia, that is, limb malformation. Shortly after the launch of the drug between 5,000 and 7,000 infants in Germany were reported to have the condition and more than 10,000 cases were reported worldwide. It was not until 1961 however, that these birth abnormalities were attributed to Thalidomide.
Individuals exposed to Thalidomide as a consequence of their mother taking the drug to ease morning sickness, suffered limb deficiencies in that long limbs did not develop properly or were stumps, whilst some infants presented with deformed eyes and hearts, blindness, deafness or deformed alimentary or urinary tracts. Of the reported cases it is thought that only 50% of affected newborns survived.
In November 1961 Thalidomide was banned worldwide.
One of the outcomes of the Thalidomide debacle has been a significant change to drug testing and approval regimes by regulators and improved advice including contraindications given to clinicians.
Nevertheless, Thalidomide has been shown to have potentially beneficial properties in the treatment of:
- HIV / AIDS
- Bechet’s Syndrome
- Rheumatoid arthritis
- Some cancers
In 1998 the US FDA approved the (strictly controlled) use of Thalidomide to treat leprosy.
Research efforts are now focussed on understanding how Thalidomide causes birth defects and in the development of analogue medications (e.g. Lenalidomide, Pomalidomide) that have the beneficial components of the drug without the side-effects.
In the US Lenalidomide was approved by the FDA in 2005 and Pomolidomide in 2013. Pomolidomide was also approved by the European Commission in 2013.