Table 2.
Post-marketing withdrawal of medicinal products because of adverse drug reactions in different continents
Continent | No. of countries | Total population (millions) | No. of withdrawn products | Rate of withdrawals/million population | Rates of withdrawal/country | RR of withdrawal per country versus Africa (95 % CI)a | a P value versus Africa |
---|---|---|---|---|---|---|---|
Africa | 54 | 1111 | 63 | 0.06 | 1.17 | – | – |
Asia | 46 | 4427 | 150 | 0.03 | 3.26 | 1.42 (1.18–1.71) | 0.001 |
Australasia & Oceania | 11 | 30 | 32 | 1.07 | 2.91 | 1.38 (1.08–1.76) | 0.045 |
Europe | 50 | 742.5 | 309 | 0.42 | 6.18 | 1.60 (1.34–1.90) | <0.0005 |
N. America | 23 | 528.7 | 134 | 0.25 | 5.83 | 1.59 ( 1.32–1.90) | <0.0005 |
S. America | 12 | 387.5 | 65 | 0.17 | 5.42 | 1.57 (1.29–1.90) | <0.0005 |
aThe P values have been corrected for multiple tests using the Bonferroni method. The relative rates of withdrawal are calculated based on the assumption that if a medicinal product was withdrawn in one country, it should also have been withdrawn in all countries in that continent. The data for total populations are obtained from the 2013 World Population Data Sheet (http://www.prb.org/pdf13/2013-WPDS-infographic_MED.pdf). This analysis excludes 43 medicinal products withdrawn worldwide