Table 1.
Major health hazards related to pharmaceuticals and administrative reforms in Japan
| Year | Events |
|---|---|
| 1962 | Withdrawal of thalidomide, which caused around 1,000 birth defects |
| 1970 | Withdrawal of clioquinol, which caused around 10,000 patients to develop SMON |
| 1979 | Establishment of the fund for relief for patients suffering from adverse drug reactions |
| 1983 | Tainted blood products caused HIV infection in nearly 2,000 hemophiliac patients |
| 1987 | Reorganization in the fund for adverse drug reaction relief and R&D promotion |
| 1987 | Tainted blood products caused HCV infection in more than 10,000 patients |
| 1993 | Suspension of MMR vaccine program, which caused nearly 2,000 aseptic meningitis sufferers |
| 1994 | Withdrawal of sorivudine, because of interaction with 5-FU, which caused the death of 18 patients |
| 1994 | Reorganization of the Organization for Pharmaceutical Safety and Research |
| 1997 | Establishment of Pharmaceuticals and Medical Devices Evaluation Center |
| 2002 | Interstitial pneumonia associated with gefitinib resulted in a class-action lawsuit |
| 2004 | Establishment of the PMDA |
| 2013 | Suspension of HPV vaccination after the controversy about CRPS being associated with vaccination |
Abbreviations: SMON, subacute myelo-optico-neuropathy; HIV, human immunodeficiency virus; R&D, research and development; HCV, hepatitis C virus; MMR, measles-mumps-rubella; 5-FU, 5-fluorouracil; PMDA, Pharmaceuticals and Medical Devices Agency; HPV, human papillomavirus; CRPS, complex regional pain syndrome.