[Prenatal exposure to psychoactive substances: results of NENUPHAR study]. / Exposition in utero à des substances psychoactives: résultats de l'étude "NENUPHAR" .

The aim of this study is to describe the impact of maternal psychotropic use or abuse on late pregnancy in newborns, using data from hospital laboratory (positive assay for psychoactive drugs). Fifty three newborns were included between 1998 and 2002. Most of cases have been exposed to benzodiazepines, opioids and cannabis. Ninety two and a half per cent had a neonatal disease. Neonatal withdrawal, respiratory disease, hypotonia and hypotrophy were the most frequent neonatal pathologies. Many cases were exposed to cannabis which might increase neonatal disease risk. These results underline the impact of psychotropic use or abuse during pregnancy on neonatal outcomes.

Adverse drug reactions related to drugs used in orthostatic hypotension: a prospective and systematic pharmacovigilance study in France.

OBJECTIVE: The aim of the present study was to investigate and characterise adverse drug reactions (ADRs) to drugs used in France for orthostatic hypotension (OH). METHODS: In this prospective and systematic study, 121 consecutive out-patients suffering from primary (Parkinson's disease, pure autonomic failure, multiple system atrophy, Lewy bodies disease) or secondary (diabetic and non-diabetic peripheral neuropathies) autonomic failure with symptomatic OH requiring pharmacological treatment with at least one drug marketed in France for OH were included together with six patients with refractory neurocardiogenic syncope. RESULTS: Of the patients, 85 received a monotherapy-mainly with midodrine (49.4%)-and 42 received various combinations, the association of midodrine and fludrocortisone being the most frequent (66.6%). Of all the 127 patients, 88 suffered from a total of 141 ADRs (1.60 per patient) with no statistical difference in ADR frequency between monotherapy and drug combinations (P>0.05). Among ADRs, 24 (17.0%) were considered as "serious" and 16 (11.3%) were considered as "unexpected", most of them observed with heptaminol. CONCLUSIONS: This study shows a high frequency of ADRs (especially serious and unexpected ADRs) with antihypotensive drugs. It strongly suggests the need for a better evaluation of the safety profile of antihypotensive drugs and improvement in summary of product characteristics.