Postmarketing surveillance studies drug development

These deliberations may result in several outcomes. Clinical development may continue as planned, but additional vigilance with more frequent visits and special tests may be added. The dose may be reduced or certain at-risk subjects may be excluded from further trials. The drug may proceed to registration, but the authorities may stipulate that a postmarketing surveillance study be conducted. The drug may be withdrawn from further clinical development. 

Spontaneous reports to the FDA and drug manufacturers/ postmarketing surveillance/ and data from ongoing observational studies and clinical trials provide other means for detecting important ADRs that may have not been detected during drug development. 

HIV-positive/AIDS patients using indinavir develop rashes early in treatment, a finding that is familiar with various other drugs used in this condition. This problem has been quantified in a study using data from postmarketing surveillance (27). Of 110 HIV/AIDS patients with a rash, 67% reported that it had occurred within 2 weeks of the start of indinavir therapy. The rash was initially localized in aU cases, but in the majority it went on to spread to other body areas, involving aU parts of the body in no less than 44%. It was usually pruritic but not accompanied by fever. Relief was often obtained by use of topical antihistamines or oral or topical glucocorticoids. More than half the patients decided to continue therapy despite the rash. 

---