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M L Efthymiou

Publications and source records attributed to M L Efthymiou.

103 records · Page 6Linked to original sources
PubMedDate not supplied

[Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months].

Omeprazole has been marketed in France since 1989, for the healing of peptic ulcers, erosive reflux esophagitis and the Zollinger Ellison syndrome. It is a proton pump inhibitor which inhibits the acid secretion in the stomach. In the majority of the clinical trials, omeprazole has been found to be well tolerated: headache, dizziness, skin rash, constipation have just been noted. Since September 1989, 143 adverse reactions have been reported to pharmacovigilance centres and Astra France: 37 neurological and psychiatric side effects, especially confusion in patients with hepatic diseases and/or advanced age; 35 cutaneous reactions, generally rash and urticaria; 22 hematological effects: leucopenia and agranulocytosis have been reported but the relation with omeprazole is very uncertain; 10 gastrointestinal effects, generally diarrhoea, nausea, vomiting and abdominal pain; 8 hepatic disorders, especially moderate elevation of aminotransferases. This study confirms the safety of this drug, during short treatment; the frequency of notified adverse effects is about 1/12 200 treatments of 4 weeks. The ministry of health, has decided, in november 1991, to inform the prescribers of this potential toxicity of omeprazole, particularly, of the risk of confusion, hepatotoxicity and leucopenia.

Adolescent↗
PubMedDate not supplied

[Clomiphene-exposed pregnancies--analysis of 39 information requests including 25 cases with known outcome].

With the up to date published data, the risk of clomiphene exposure during pregnancy cannot be determined. After a review of animal experimentation results, we will discuss the human data. Most of the publications with human exposition concern treatments given before the beginning of pregnancy. The questions addressed to the Centre de Pharmacovigilance of Paris F. Widal will be detailed. From May 1983 to July 1995 39 requests are available with only 25 cases of known outcomes. For these 25 cases, five elective terminations and three spontaneous abortions are reported. Only one defect was observed among the 17 births (9 females, 8 males): unilateral fibula agenesis the imputability of which is difficult to establish. These data seems reassuring; however, the number of patients studied is small. Other studies on clomiphene-exposed pregnancies are necessary in order to investigate this risk.

Abnormalities, Drug-Induced↗
PubMedDate not supplied

[Pharmacovigilance off the beaten track: herbal surveillance or pharmacovigilance of medicinal plants].

For several years, herbal medicines have been increasingly consumed by patients without prescription. They are traditionally innocuous but as medicinal products they require drug surveillance in order to identify their risks. However, the first concern is to give them a legal status, to evaluate their efficacy and to control their safety. Published data show that the risk is due either to a contaminant or to an added drug or falsification. Since 1985, the Regional Pharmacovigilance Centres have received about 341 reports of undesirable effects due to herbal medicines: among them 30 cases of hepatitis were reported associated with germander which has been now withdrawn from the French market. This example well illustrates the role of the national system and its responsibility for collecting and evaluating ADRs due to herbal medicines.

Adverse Drug Reaction Reporting Systems↗