Drugs can still be withdrawn from sales or restricted after getting approval. That is why the data is collected. Many adverse effects are only noted when very large numbers of patients are treated. The best known example is the anti-nausea drug Thalidomide which causes severe limb deformities in foetuses.Perspect Clin Res. 2010 Apr-Jun; 1(2): 57–60.PMCID: PMC3148611PMID: 21829783Phase IV of Drug Development
No matter how many patients are studied pre-marketing in a controlled environment, the true safety profile of a drug is characterized only by continuing safety surveillance through a spontaneous adverse event monitoring system and a post-marketing surveillance/non-interventional study.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/
Ann: Media release - First stroke patient with afamelanotide, page-22
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