Home About us Contact
|
Home About us Contact | ||
|
|
||
Serious Adverse Drug Reaction (serious + adverse_drug_reaction)
Selected AbstractsEfficacy of four insect repellents against mosquito bites: a double-blind randomized placebo-controlled field study in SenegalFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 5 2009Bernard Uzzan Abstract Insect-borne diseases represent a worldwide threat. In addition to fight against vectors (insecticides) and disease prevention (vaccination against yellow fever, chemoprophylaxis against malaria), insect repellents applied on the skin could help reduce the heavy burden related to these diseases. In a field study performed in Senegal, we compared the efficacy of one skin application between 3 and 4 p.m. of four spray repellents [icaridine 20%, para-menthane-diol (PMD) 20% and 50% and DEET 50%] against placebo, among 100 healthy male and female volunteers experienced with mosquito capture. Double-blind randomized cross-over placebo-controlled study (Latin-square design) during five consecutive nights (7 p.m. to midnight) in two villages was conducted. To avoid residual effect, right or left leg was alternately exposed during consecutive nights and the exposed leg was washed before next night. The statistical model was random and mixed effects anova. All four active repellents provided a significant and similar protection compared with placebo, lasting 8 h. However, there was a non-significant trend for a higher protection by DEET 50% than by PMD 20% (P = 0.07). Duration of protection was similar for all repellents. Their effects were similar among men and women, and against Anopheles or other species. No serious adverse drug reaction was noticed. Using a rigorous methodology and a large number of volunteers, our well-controlled study demonstrated an important and similar protective effect of all four repellents compared with placebo. Such field studies should be required before approval of any newly developed repellent. [source] Proton pump inhibitor-induced acute interstitial nephritisBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 6 2007Linda Härmark What is already known about this subject ,,In several case reports the use of omeprazole has been associated with interstitial nephritis. ,,Recently there have been reports linking other proton pump inhibitors (PPIs) with interstitial nephritis. What this study adds ,,We present supplementary cases received by the Netherlands Pharmacovigilance Centre Lareb, concerning interstitial nephritis in users of PPIs including omeprazole, pantoprazole and rabeprazole. ,,In this case series seven patients are presented. In six cases they recovered spontaneously after cessation of the PPI, in one case the patient recovered after treatment with a corticosteroid. ,,Further support for this association comes from the worldwide adverse drug reaction database of the World Health Organization. ,,This report shows that interstitial nephritis can occur with all PPIs. Health professionals should be aware of this potential serious adverse drug reaction. Aim To investigate the association between the use of proton pump inhibitors (PPIs) and acute interstitial nephritis (AIN). Methods The Netherlands Pharmacovigilance Centre Lareb received seven case reports of AIN induced by various PPIs. In five of the reports it was mentioned that the diagnosis was confirmed by a renal biopsy. Results The time to onset varied between hours to 4 months. In all cases but one the patient spontaneously recovered after withdrawal of the offending agent. In one case the patient received treatment with prednisolone and recovered. In one patient a rechallenge was done 9 days after the initial event. Within 12 h of re-exposure the patient developed symptoms of AIN. Conclusions The mechanism of drug-induced AIN is unknown, but an immunological mechanism is suspected. Our reports show no relation between dosage, latency, time to recovery, age or gender, supporting the hypothesis that the aetiology of AIN is immunological. Lareb has received reports of AIN with the use of omeprazole, pantoprazole and rabeprazole. This shows that AIN is a complication associated with the whole group of PPIs and not only omeprazole. It is important for health professionals to be aware of this adverse drug reaction, because an accurate and timely diagnosis and withdrawal of the offending drug can prevent potentially life-threatening renal failure. [source] Dextropropoxyphene withdrawal from a French university hospital: impact on analgesic drug consumptionFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 2 2009Sabine Gaubert Abstract Dextropropoxyphene is a weak opioid analgesic, widely used as a step 2 analgesic (according to WHO classification) in combination with peripheral analgesics, mainly paracetamol. Recent data have underlined its poor analgesic efficacy (in comparison with paracetamol), risks of serious adverse drug reactions (i.e. hepatic reactions, hallucinations, abuse, withdrawal symptoms, hypoglycaemia), possible lethality after overdose, its risk of accumulation in patients with renal failure or in elderly people and some pharmacokinetic insufficiencies (i.e. different half-lives for dextropropoxyphene and paracetamol). Taking into account these data, the drug committee of the Toulouse University Hospital (France) decided to withdraw dextropropoxyphene from the hospital formulary since 1 June 2005. The aim of our study was to investigate the consequences of this withdrawal by comparing use of analgesic drugs in Toulouse University Hospital before (2004) and after (2006) dextropropoxyphene withdrawal (using defined daily dose for 1000 hospitalization-days as the unit measure). Before withdrawal, dextropropoxyphene (in combination with paracetamol) was the second most used analgesic drug after paracetamol alone. After dextropropoxyphene withdrawal, total consumption of analgesic drugs decreased by 4.6% (2006 vs. 2004). There was a 28% decrease in consumption of step 2 analgesics [with an increase in oral tramadol and a slight decrease in codeine (in combination with paracetamol)]. During the same period, step 1 analgesic consumption increased by 11% (mainly paracetamol) and that of step 3 analgesics slightly decreased (,8%). These results show that dextropropoxyphene withdrawal was not associated with a marked switch in prescriptions towards other analgesic drugs. This paper underlines the interest of a hospital-based drug committee to promote rational drug use. Finally, the present data allow us to discuss putative misuse of dextropropoxyphene. [source] Developing an optimal approach to global drug safetyJOURNAL OF INTERNAL MEDICINE, Issue 4 2001R. Balkrishnan Abstract.,Balkrishnan R, Furberg CD (Wake Forest University School of Medicine, Winston-Salem, NC, USA). Developing an optimal approach to global drug safety (Review). J Intern Med 2001: 250; 271,279. An increasing number of media reports on a number of marketed drugs withdrawn because of harmful effects, a scientific report on epidemic proportions of serious adverse drug reactions in hospitalized patients, and a disturbing report on medical mistakes that includes medication errors have recently all brought drug safety into intense focus and placed it under greater scrutiny. Concerted efforts are now being made to understand the causes of drug safety problems and to find ways to reduce their frequency. An international symposium, ,Developing an Optimal Approach to Drug Safety' was held at Wake Forest University in the Fall of 2000 to identify the issues and solutions to extant problems in this area. This report summarizes the resulting discussions of global postmarketing surveillance initiatives and describes efforts to reduce medication errors, and improve global communication about drug safety. [source] | ||||||||||