[Drug-induced pancreatitis. A review of French spontaneous reports]. / Pancréatites d'origine médicamenteuse. Revue des notifications spontanées en France.

PURPOSE: Identify the main pharmacological classes inducing pancreatitis using spontaneous reports recorded in the French pharmacovigilance database (FPVD). METHODS: Cases of pancreatitis recorded in FPVD between January 1st 1985 and December 31st 2013 were selected using the 2001 consensus conference criteria of the French High Health Authority. RESULTS: During this period, 2975 observations were selected with 1151 fulfilling criteria of drug-induced pancreatitis (i.e. 0.22% of total notifications in the FPVD). According to ATC classification, the pharmacological classes most frequently found were antiretroviral, analgesic, lipid-lowering, immunosuppressive and insulin secreting drugs. For some drugs (metformin, omeprazole, etc.) pancreatitis was "unlabelled" in the summary of product characteristics. CONCLUSION: This review allows to identify the main drug classes currently involved in spontaneous reporting of pancreatitis in France.

[Colchicine intoxication in four elderly patients: how to prevent it?]. / Risque d'intoxication à la colchicine chez les personnes âgées et moyens de prévention: à propos de quatre observations.

INTRODUCTION: In France, unlike other countries, the use of colchicine is preferred to other anti-inflammatory drugs for the treatment of gout. CASE REPORTS: We report a case series of four elderly patients (range from 72 to 83 years of age) who presented with colchicine intoxication, all notified to the Basse-Normandie pharmacovigilance centre in 2007. For each patient, one or more risk factors were identified: renal failure, high initial dosage, absence of laboratory monitoring. CONCLUSION: It would be useful to establish specific guidelines for colchicine use in the elderly population.

[Trimetazidine-induced encephalopathy with choreiform disorders: a case report]. / Encéphalopathie avec mouvements choréiformes induits par la trimétazidine: à propos d'un cas.

Trimetazidine is known to induce parkinsonism but choreiform disorders have not yet been described with this drug. A 88-year-old patient treated with trimetazidine developed choreiform movements, gait disorders, tremor and visual hallucinations. These symptoms disappeared after drug withdrawal. Although this drug contains a piperazinic ring like other anti-dopaminergic drugs which are already known to potentially induce chorea like neuroleptics and some anti-convulsive drugs. When a patient treated with trimetazidine develops or worsens motor disorders (parkinsonism or choreiform disorders), this drug must be stopped.

[Should we care about pregabalin for elderly patients with a history of cardiac dysrhythmia?]. / Faut-il se méfier de la prégabaline chez les patients âgés aux antécédents de troubles du rythme cardiaque ?

Pregabalin is similar in structure to gamma-aminobutyric acid. It is used for neuropathic pain, generalized anxiety disorders and as an adjunct therapy for partial seizures. Tachycardia is a rare side-effect. A 92-year-old patient with a history of paroxystic fibrillation was hospitalised for zoster. She developed a sinusal tachycardia followed by atrial fibrillation and congestive heart failure 15 h after a first dose of pregabalin. The imputation was considered as plausible. Even though the mechanism remains unclear, pregabalin might induce tachycardia in predisposed old patients.

[The respiratory system and safety pharmacology]. / Système respiratoire et pharmacologie de sécurité.

Many drugs affect respiration in man. The changes in respiratory function following their administration are due to a direct effect on the respiratory system or are the consequence of a central, metabolic (alteration of the acid-base balance) or vascular effect (pulmonary hypertension). Regulatory documents (CPMP, FDA and MHW drafts) are in agreement in considering the respiratory system as a vital function to explore during safety pharmacology studies. On the basis of these recommendations, the first studies to be performed should be on conscious unrestrained animals, in general the drug being administered as a single dose. The effects on the respiratory function are best studied by plethysmography in the guinea-pig or rat. The measurement of ventilatory parameters--respiratory rate, tidal volume, inspiratory time, expiratory time, peak inspiratory flow, peak exploratory flow and resistance--allow the differentiation between drugs affecting respiratory control and those altering lung mechanical properties. The pulmonary hypertension risk could be evaluated in the dog during haemodynamic studies. Finally, the study of the effects on blood gases should always be carried out in conscious animals, usually in the dog. For drugs belonging to pharmacological classes presenting a high respiratory risk, complementary studies should be considered. The extrapolation from healthy persons to ill patients (especially chronic respiratory insufficiency patients) of the incurred risk is often difficult. For this reason, it is very useful to study the effect of such drugs on the respiratory function of pathological animals.

[Anaphylactoid reactions to an injectable solution of a cremophor-containing solution of multivitamins]. / Réactions anaphylactoïdes à une solution polyvitaminée injectable contenant un crémophore.

We report four anaphylactoid reactions after intravenous administration of a cremophor-containing multivitamin hydrosol (Hydrosol Polyvitaminé Roche), observed over an 8-month period in a small region of France. The reactions occurred immediately following intravenous infusion of either ionic solutions or parenteral nutrition mixture containing the multivitamin solution. In three cases, erythema and dyspnoea appeared within minutes. The infusion was rapidly stopped and corticosteroids were given to two patients. The fourth patient had erythema and swelling of the face within 30 min of infusion, and severe bronchoconstriction and hypotension within 60 min, before infusion was stopped. In-vivo histamine release from mast cell was proved. These reactions are highly suggestive of an anaphylactoid mechanism, due to the multivitamin solution, as all the other drugs were continued without subsequent reactions. The responsible agent is thought to be polyethoxylated castor oil (Cremophor EL), as it is known to produce such effects. Medical practitioners should evaluate the risk/benefit ratio each time they give this drug.

[Adrenergic therapy and vigilance: beta-2 sympathomimetic aerosols in asthma]. / Médicaments adrénergiques et pharmacovigilance: les aérosols de bêta-2 sympathomimétiques dans l'asthme.

It has been established that the use of beta-2 sympathomimetic aerosols is a safe and efficacious treatment of asthma. Unexpected cases of sudden death amongst insufficiently-treated patients or patients who stopped their treatment are not linked with the use of these drugs. To assess the risk of possible "receptor desensitization" it is necessary to notify these accidents to the Committee on Safety of Drugs and to take into consideration the opposite results of further administration and termination of treatment.