A new breakthrough in this field only happened after an episode occurring in 1937. In that year, Sulfanilamide (Prontosil), used since 1932 for treatment of streptococcal infections, was launched as a syrup, containing diethyleneglycol as solvent. Although tested regarding aspect, taste and odor, its safety was not evaluated before launching. It was responsible for the death of 105 individuals (34 children and 71 adults) and diethyleneglycol was incriminated. This tragedy caused the American Congress to approve in 1938 the Food Drug and Cosmetic Act, under which pharmaceutical product manufacturers would have to show scientific evidences of the safety of the drugs before releasing themfor sale.
The thalidomide tragedy is a milestone in the origin and development of pharmacovigilance. Thalidomide was introduced in 1957 and widely prescribed as an allegedly harmless treatment for morning sickness and nausea. It was tested in approximately 300 patients without toxicity. It was soon linked to a congenital abnormality phocomelia, which caused severe birth defects in children of women who had been prescribed this medicine during pregnancy. In 1962, after reports of numerous cases of phocomelia, it was discontinued. In the same year, the Kefauver-Harris amendment was approved, requiring scientific evidences of efficacy and safety before drug tests in humans. [2]
As a means of pooling existing data on ADRs, WHO's Programme for International Drug Monitoring was started in 1968. Initially a pilot project in 10 countries with established national reporting systems for ADRs, the network has since expanded significantly as more countries worldwide developed national pharmacovigilance centers for the recording of ADRs. Currently, 86 countries participate in the programme, which is coordinated by WHO together with its collaborating centre in Uppsala, Sweden. The collaborating center is responsible for maintaining the global ADR database, Vigibase. At present the database contains more than four million ADR reports
The thalidomide tragedy is a milestone in the origin and development of pharmacovigilance. Thalidomide was introduced in 1957 and widely prescribed as an allegedly harmless treatment for morning sickness and nausea. It was tested in approximately 300 patients without toxicity. It was soon linked to a congenital abnormality phocomelia, which caused severe birth defects in children of women who had been prescribed this medicine during pregnancy. In 1962, after reports of numerous cases of phocomelia, it was discontinued. In the same year, the Kefauver-Harris amendment was approved, requiring scientific evidences of efficacy and safety before drug tests in humans. [2]
As a means of pooling existing data on ADRs, WHO's Programme for International Drug Monitoring was started in 1968. Initially a pilot project in 10 countries with established national reporting systems for ADRs, the network has since expanded significantly as more countries worldwide developed national pharmacovigilance centers for the recording of ADRs. Currently, 86 countries participate in the programme, which is coordinated by WHO together with its collaborating centre in Uppsala, Sweden. The collaborating center is responsible for maintaining the global ADR database, Vigibase. At present the database contains more than four million ADR reports
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