Case reporting systems pharmacovigilance

Hair Strontium hydroxide has been used as a depilatory [58 ], and it is not therefore surprising that there have been reports of alopecia in patients taking strontium ranelate. In a series of five cases reported to the Spanish pharmacovigilance system [59 ], the odds ratios (95% Cl) for the risks of alopecia in postmenopausal women taking various drugs were ... 

Pharmacovigilance in complementary and alternative medicine Pharmacovigilance in complementary and alternative medicine has attracted much attention worldwide. The awareness of the need for surveillance of adverse reactions to natural health products has stimulated the implementation of a reporting system for suspected adverse reaction in Italy From April 2002 to March 2007, 233 spontaneous reports of suspected adverse reactions to natural health products were collected. A large proportion of the suspected adverse reactions were serious hospitalization was reported in 35% of cases 6% reported life-threatening clinical events, and there were two fatal events. Most of the reported cases involved herbal products (66%) 21 reports were associated with 27 homeopathic preparations, most of which contained a mixture of substances 14 reports attributed the suspected reactions to products containing propolis. 

The national pharmacovigilance system in France have reported 5 cases where eolehieine appeared to increase the anticoagulant effect of fluindione. All 5 patients were stabilised on fluindione and were given shortterm eolehieine 1 to 6 mg daily for an acute attack of gout. All 5 patients had markedly raised INRs (6.5 to in excess of 18), but only one had clinical bleeding (haemorrhoidal bleeding). The authors consider that colchicine may have been a factor in a case of raised INR with warfarin, which was attributed to the SSRI , (p.448), fluvoxamine. 

Moore N, Kreft-Jais C, Haramburu F, Noblet C, Andrejak M, Ollagnier M, Begaud B. Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs a case/non-case study in the French pharmacovigilance system database. BrJClin Pharmacol (1997) 44, 513 8. 

Nervous system Aripiprazole has been previously associated with neuroleptic malignant syndrome but with doubts about the validity of the diagnoses. However, postmarketing pharmacovigilance schemes in Australia have collected a higher proportion of cases of neuroleptic malignant syndrome with aripiprazole compared with the total number of reports received for... 

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. 

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