Lareb

ADR monitoring ADRAC National Centre for Pharm. Surveillance, Min. of Health y SAM DCA/NPCB MEB+LAREB National Pharmaco-vigilance Centre 7 INH MCAZ... 

Name of ADR Centre/dept. of DRA /adrac National Centre for Pharm. Surveillance/- DIPC/- National Pharmaco- vigilance o Centre/- MAD RAC/- LAREB/No National Pharmaco- vigilance o Centre/- y CENAVIF/Yes ADR Committee/... 

The Netherlands PharmacovigUance Foundation (LAREB), has reported five cases of transient difficulty in urinating, which spontaneously resolved on withdrawal of tramadol and was suspected to be induced by tramadol none needed catheterization (46). In all five cases tramadol had been prescribed for back pain in relatively healthy individuals in a dose range of 50-150 mg. 

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. 

The Netherlands Pharmaeovigilanee Foundation (LAREB) have 9 eases of menstrual ehanges on their reeords in women taking an oral eontraeeptive during or after taking itraconazole 100 to 400 mg daily for 1 to... 

Electrolyte balance Four cases of severe symptomatic hyponatremia or the syndrome of inappropriate antidiuretic hormone secretion in association with valproic acid have been reported to the Netherlands Pharma-covigilance Centre Lareb, giving support to the hypothesis of a causal relation between valproate and these complications [329 ]. Another case has been described in a patient with bipolar disorder [330" ]. 

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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