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E Loupi

Publications and source records attributed to E Loupi.

At least 19 recordsLinked to original sources
PubMed2001

[Evaluation of tolerance to endovesical BCG treatment in France: analysis of severe adverse effects notified in 3 years].

OBJECTIVES: Intravesical BCG therapy remains the first-line prophylactic treatment for recurrences of superficial bladder tumours. However, necessary the safety of this medicinal product, for which a potential risk of complications was demonstrated during development, needs to be evaluated. MATERIAL AND METHODS: Based on spontaneous notifications of adverse events reported according to good pharmacovigilance practice and in the context of a survey conducted jointly with Health Authorities, the authors present an analysis of adverse event notifications received by the manufacturer over a three-year period. A summary of serious adverse events (SAE) was established and hypotheses concerning factors predisposing to these adverse events were discussed. Finally, practice guidelines were formulated. RESULTS: During this period, 97 SAEs were reported spontaneously, including 12 local SAEs, 12 regional SAEs and 73 systemic SAEs. 46 of the 73 systemic SAEs were suspected to be due to BCG infection, 18 were related to immune disorders and the cause of 9 SAEs could not be determined. Several hypotheses are formulated concerning the circumstances leading to the onset of these SAEs and practice guidelines are proposed. CONCLUSION: Pharmacovigilance has allowed a better understanding of the qualitative and quantitative safety of BCG-IT in France. Hypotheses concerning factors predisposing to adverse effects were formulated and practice guidelines were proposed. It is essential to continue this collaboration between practitioners, Health Authorities and the manufacturer to ensure optimal use of this medicinal product.

Adjuvants, Immunologic↗
PubMed1999

[Trismus and tetanus vaccine].

BACKGROUND: Tetanus immunization, mandatory in France before the age of 18 months, is usually well tolerated. Fever and local reaction at the site of injection are the most common side effects. We report a case of trismus associated with tetanus immunization. CASE REPORT: A 12-year-old boy was hospitalized for a trimus which occurred 22 h after a booster dose of tetanus polio vaccine. The spasm of masticator muscles was so severe that the patient had difficulties in elocution and feeding. A moderate fever and a hypertonia of the lower limbs were associated. The trismus resolved itself within about 5 min after diazepam intravenous infusion. After examination of the buccal cavity, a local cause was discarded. The outcome was favorable and the clinical status of the boy was still normal six months later. DISCUSSION: Although no similar cases have been published, 13 other comparable adverse events associated with four vaccines containing tetanus toxoid were reported to the manufacturer within a period of 12 years. During the same period, more than 66 millions doses of vaccines containing tetanus toxoid were distributed. Trisms appeared to be more likely reported in adults after booster doses. Onset of the symptoms was between a few hours to 15 days. Outcome was always favorable. CONCLUSION: Although trimus associated to tetanus toxoid immunization is rare and remains unexplained, physicians should be aware of this adverse event.

Adult↗
PubMed1998

[Risks associated with vaccinations].

Since Jenner and Pasteur, various vaccines have been developed and administered in immunization program conducted by WHO in order to diminish the circulation of pathogenic agents and eradicate some diseases. Risks associated with immunization are revealed by the collection and assessment of adverse events reported after the use of these drugs. They vary according to the type of vaccines. With high rates of immunization and a low incidence of infectious diseases, adverse events receive increasing attention. Frequent and mostly expected adverse events are reported in clinical trials. Unexpected rare adverse events are reported after marketing authorization by spontaneous reporting and post marketing surveillance studies. Post marketing surveillance should be adapted to vaccines (vaccino-vigilance) and should take into account the risk linked to the disease they may protect against. Adverse events are often temporally associated with vaccines, that does not mean they are causally related. Specific studies should be conducted to assess the causal relationship between vaccines and post immunization adverse events. In order to reduce the risk associated with immunization, a strict follow-up of recommendations, warnings and contraindications in addition to appropriate information being delivered to both vaccinees and physicians are required.

Adult↗
PubMed1997

Bali Low.

Explore the source record for details and available documents.

Chloroquine↗
PubMed1993

Does proof of casualty ever exist in pharmacovigilance?

Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. Objective proof of a causal relationship between a drug and a specific event is quite exceptional. In most cases, this relationship remains subjective and is no more than inner conviction. Several means are at our disposal to achieve causal assessment: spontaneous reporting, clinical trials, cohorts with and without controls, and case-control studies, with each having advantages and limitations. The search for casualty in pharmacovigilance is a necessary scientific goal, but a high degree of suspicion may be all that is necessary to withdraw a drug from the market if it is suspected of causing serious adverse effects.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

[Misuse and or overdose of BCG vaccine: evaluation over a 4-year period].

The inappropriate use of BCG vaccine could be followed by adverse events (AE). In order to know their frequency and type, we evaluated the spontaneous reports of misuses (MS) and overdosages (OV) over a 4-year period. One hundred and twenty-six notifications were collected; 109 concerned MS, 13 OV, and 4 concerned both MS and OV. We recorded a high number (97) of MS related to the injection of a BCG vaccine instead of a tuberculin test (TT). Among the 126 initial notifications, 122 cases of AE were reported, 107 after an MS, 11 after an OV and 4 after both MS and OV. The most common AE were related to injection-site reactions which were in fact expected reactions when BCG is used under correct conditions. In half of the cases systemic signs were associated. The most common were asthenia, fever and lymphadenopathy. Seven cases related to MS were considered as serious according to the ICH definition. Six of them recovered, for one the outcome was unknown. It appeared that perhaps the presentation of the products BCG vaccine and TT could play a role in contributing to this inappropriate use. Both presentations contain 10 doses but there are significant differences in colours used and in specific instructions. Despite the fact that the AE reported after an MS and/or an OV represented the one-third of the total notifications recorded with the BCG vaccine over the 4-year period under review, they have to be considered in light of the 170 million doses distributed in 150 countries. We have to consider the possibility of under reporting because of the delicacy of incorrect administration and differences in pharmacovigilance structures worldwide. Even if the number of AE is low, MS and OV should be reported and documented for good pharmacovigilance surveillance.

Adjuvants, Immunologic↗