There are many examples of the importance of ADRs reporting in the improvement of information in labelling of many effective pharmaceutical products (new possible ADRs, contraindications, dosage etc.).
Cyclophosphamide has been on the market for several years in many countries. In January 2001 there were some new reactions included in the labels: Stevens Johnson syndrome and toxic epidermal necrolysis; they were not included in the Physician Desk Reference (PDR) 1995.
For example:
EPIDERMAL NECROLYSIS
ERYTHEMA MULTIFORME
STEVENS JOHNSON SYNDROME
Losartan was marketed in the USA since 1995. Some of the new reactions that have been discovered after launch and included in the PDR are:
VASCULITIS
PURPURA ALLERGIC
(incl. HENOCH-SCHOENLEIN PURPURA)
ANAPHYLACTIC SHOCK
ANAPHYLACTOID REACTION
Levofloxacin was launched in the USA in 1997. In February 2000 the label torsade de pointes was included.