Adverse Drug Reaction

Thalidomide disaster of 1961

Thalidomide a tranquilizer and hypnotic synthesised in 1953 patented in 1957 and marketed in Europe in 1958 after toxicity studies in mice and other lab animals as well as man showed it to have very little toxicity. It became very popular, and in 1961 around 1.5 tons were distributed. No prescriptions were required. In April 1961 polyneuritis was observed in long-term users and phocomelia and melia in newborns were associated with the use of the drug by their mothers during pregnancy. On November 26 1961 in Germany and on the 27 in UK, thalidomide was withdrawn from the market. However in USA, the consumers reports of peripheral neuritis delayed registration by the FDA. Hence, pregnant consumers were protected in the USA whereas in Germany alone 3000 deformed children lived.

On this journey from being effective drugs with low toxicity to either withdrawal or regulatory action, it was the consumer who experienced the ADR and played the role.
Known side effects include dependence, drowsiness and lightheadedness the next day; confusion and ataxia, amnesia may occur; dependence; paradoxical increase in aggression, muscle weakness; occasionally : headache, vertigo, hypotension, salivation changes, gastro-intestinal disturbances, rashes, visual disturbances, dysarthria, tremor, changes in libido, incontinence, urinary injection, pain, thrombophlebitis, and rarely apnoea; raised liver enzymes. It was the same sequence of events, with the selective serotonin re-uptake inhibitors (SSRIs), cisapride, astemizole and many more drugs.