Effects of the European restrictive actions concerning nimesulide prescription: a simulation study on hepatopathies and gastrointestinal bleedings in Italy.

In 2002 and 2007 the European Medicines Agency (EMA) examined the signals of a greater risk of hepatopathies related to nimesulide use. In 2007 restrictive actions were adopted in Europe. Moreover, EMA initiated a new referral in February 2010. The objective of this paper is to evaluate the effects of the 2007 regulatory measures concerning nimesulide and to estimate the potential effect of further actions. Specifically, we carried out a simulation on the expected number of hospitalisations for hepatopathies and upper gastrointestinal bleedings (UGIBs) in Italy before and after the regulatory measures (2006 vs. 2009), taking into account the shifting of nimesulide prescriptions on other non steroidal anti-inflammatory drugs (NSAIDs). The expected figures of hospitalisation for hepatopathies and UGIBs for all NSAIDs were calculated on the basis of risk estimates reported in two epidemiological studies. The result of the simulation suggests that the implementation of the restrictive actions might prevent 79 events of liver injuries, but might increase UGIBs by 859 events. The simulation helped to clarify the effects on hepatopathies and UGIBs as a consequence of nimesulide restriction of use. Analogous simulations might be conducted when assuming regulatory actions.