Lareb Netherlands Pharmacovigilance

Example In follow-up of the receipt of 7 reports acute interstitial nephritis (AIN) by the Netherlands Pharmacovigilance Centre Lareb, the databank of World Health Organisation Collaborating Centre for International Drug Monitoring in Uppsala, Sweden (containing about 3.7 million spontaneous reports from more than 80 countries worldwide) was searched for cases of AIN. A total of 150 AIN cases with recorded proton-pump inhibitors (PPI) use was found. The proportionality of PPI use within the AIN cases was compared to the same in the rest of all 3.7 million reports, resulting in a ROR of 9.4 for omeprazole. 

Pancreas Four cases of pancreatitis in patients taking relatively high doses of itraconazole have been reported to the Netherlands Pharmacovigilance Centre Lareb. In two cases, recurrent use of itraconazole resulted in recurrent symptoms pS ]. 

Sensory systems, ear Six cases of hearing impairment attributed to oral terbinafine intake were reported to the Netherlands Pharmacovigilance Centre Lareb [4 ]. Both male and female were involved and the latency between terbinafine use and hearing impairment was from 2 days to 6 months. Outcomes for two cases were reported and the patients recovered after withdrawal of terbinafine. 

Scholl JH, van Puijenbroek EP. Hearing impairment associated with oral terbinafine use a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase. Drug Saf 2012 35(8) 685-91. 

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