Effects of a systematically offered social and preventive medicine consultation on training and health attitudes of young people not in employment, education or training (NEETs): An interventional study in France.

Background: NEETs (young people not in employment, education or training) are at higher risk for poorer mental and physical health. In France, the Missions locales (MLs) are the only social structures dedicated to this population. We sought to determine whether the systematic offer of a social and preventive medicine consultation at a ML might increase NEET participants' access to training in the 12 months following the intervention.

[Health and access to health care of 18-25 years old people not in employment, education or training (NEETs) attending the French 'missions locales'].

Background: In France, "missions locales" are public assistance units for young people aged 16-25 years not in employment, education or training (NEET). The health status of the more than 1.5 million young adults attending these units annually is unknown.

Validation and Reproducibility of the Updated French Causality Assessment Method: an Evaluation by Pharmacovigilance Centres & Pharmaceutical Companies.

Objective: Assess the validity and reproducibility of the updated version of the French causality assessment method in conditions approaching real-life use.

Methods: A random sample of 31 drug-event pairs from the French pharmacovigilance database was assessed by the consensual judgement of three experts (gold standard). Separately, a team from a pharmacovigilance centre (PhVC) and another from a pharmaceutical company assessed these pairs using the current method, then with the updated method.

Updating the French method for the causality assessment of adverse drug reactions.

The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale.

Liver Transplantation because of Acute Liver Failure due to Heme Arginate Overdose in a Patient with Acute Intermittent Porphyria.

In acute attacks of acute intermittent porphyria, the mainstay of treatment is glucose and heme arginate administration. We present the case of a 58-year-old patient with acute liver failure requiring urgent liver transplantation after erroneous 6-fold overdose of heme arginate during an acute attack. As recommended in the product information, albumin and charcoal were administered and hemodiafiltration was started, which could not prevent acute liver failure, requiring super-urgent liver transplantation after 6 days.

[Update of the French drug reaction assessment method].

A tripartite group, entitled « CRI » (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed: a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction.

[Not Available].

A tripartite group, entitled « CRI » (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed : a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction.

Cysteamine toxicity in patients with cystinosis.

Objective: To report new adverse effects of cysteamine.

Study Design: Detailed clinical information was obtained from the patients' physicians.

Results: New adverse events were reported in 8 of 550 patients with cystinosis treated with cysteamine in Europe during the last 5 years.

Plasma levels of oxybutynine chloride in children.

Anticholinergic adverse-effects in children treated with conventional doses of oxybutynine led us to measure plasma oxybutynine levels in children. 18 children, aged 5 to 13 y, who required treatment with oxybutynine chloride for daytime incontinence were studied. Plasma concentrations were measured on the fifth day of a course of treatment in which the dose was adapted to the child's body weight; the dose was given twice daily at 12-hour intervals.

[Children's participation in biomedical research. A planned survey of 541 parents].

Background: We have interviewed the parents of children born at two maternity hospitals to evaluate the knowledge of parents concerning the French Huriet law and their consent to the participation of their child in a randomized therapeutic trial.

Methods: The inquiry was conducted between 15 February and 30 April 1991. Each couple of parents of whom the mother had given birth in one of the hospitals was sent an explanatory letter and a questionnaire on the second day after delivery.

Inhibition of angiotensin converting enzyme with enalapril maleate in infants with congestive heart failure.

We studied the inhibition of angiotensin converting enzyme (ACE) in eight infants with congestive heart failure (CHF) poorly controlled with digoxin and diuretics, treated orally with 0.25 mg kg-1 enalapril maleate once a day. Baseline ACE activities were compared between these infants and control children without CHF or ACE inhibitor.

[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics].

Background: The side effects of oxybutynin chloride (Ditropan) often include atropinic and allergic reactions. Their relative frequency in children merits a nationwide investigation.

Methods: All the side effects of Ditropan reported to the French Regional ADR monitoring centers and to the pharmaceutical firm Debat between January 1985 and June 1990 were analysed.

Parental opinions about biomedical research in children in Tours, France.

In order to evaluate parental awareness of the law governing clinical trials in France (Loi Huriet), a study was performed by questionnaire between February and April 1991 in a maternity unit during the days following delivery. The response rate was 59%. 59% of the parents (319/541) were informed of the existence of the law by the media (75%) or their general practitioners (12%).

Pharmacokinetics of paracetamol in the neonate and infant after administration of propacetamol chlorhydrate.

The pharmacokinetic parameters of paracetamol were studied after 15 min intravenous infusion of 15 mg/kg of propacetamol (Prodafalgan) in 5 neonates aged less than 10 days and 7 infants aged between 1 and 12 months. Blood was sampled at 0, 0.5, 2 and 6 h after the first intravenous infusion of propacetamol.

[Pulmonary toxicity of nilutamide (Anandron). Cooperative evaluation of French Regional Pharmacovigilance Centers].

We have studied 12 reports of pneumonitis associated with nilutamide (Anandron) and notified to the French regional ADR monitoring centers between November 1987 and June 1990. The mean age of the patients was 71.5 +/- 9.

[Adverse effects of oxybutynin chloride (Ditropan). Evaluation of the official survey of Regional Pharmacovigilance Centers].

We analyzed the 200 reported cases of adverse reactions to Ditropan (209 side-effects) collated by the Centres Régionaux de Pharmacovigilance and Laboratoire Debat since the drug was first marketed. The frequency of such side-effects was of the order of 1 per 20,917 treatment months. Children were affected four times more frequently than adults.

Oxaflozane overdose in a child.

A case of severe poisoning in a 2 year-old child who ingested 150 mg of oxaflozane, a non-tricyclic antidepressant, is reported. After loss of consciousness, opisthotonos and coma, recovery was obtained with conservative treatment. Atropine-like symptoms were noted.

Seizure with hyponatremia in a child prescribed desmopressin for nocturnal enuresis.

We report a case of hyponatremia associated with a grand mal seizure in a 28 month-old child after intra-nasal desmopressin administration for high fluid intake with nocturnal enuresis. In view of the temporary symptomatic action and the seriousness of certain side-effects of desmopressin we recommend that desmopressin be used with caution in childhood enuresis.

[Amineptin dependence and iatrogenic acne. Review of the literature apropos of a case].

We relate the case of a drug addict of 31 years old whose dependence to the amineptine got complicated with severe acne-like lesions, as it sometimes happens. Compared, with teenage acne, severe acne can be distinguished by its late out break, its monstrous nature and its larger surface area. Amineptine has been found (or its metabolites) in the plasma, the urine.

[Drug utilization at the end of pregnancy].

To evaluate drug utilization during the last 15 days of pregnancy, one hundred six women were interviewed post-delivery in the CHU Bretonneau in Tours. Eighty-three percent received at least one drug during the 15 days preceding delivery and 27% more than 3 different drugs. Treatments for venous disorders (31% of patients), iron (31%), analgesics (25%), antacids (11%), magnesium (11%) and laxatives (11%) were most frequently used.