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Biomedical subjects

F Haramburu

Publications and source records attributed to F Haramburu.

At least 19 recordsLinked to original sources
PubMed2006

[Psychiatric adverse effects of fluoroquinolone: review of cases from the French pharmacologic surveillance database].

INTRODUCTION: Psychiatric adverse effects of fluoroquinolones are known for long, but can sometimes be missed. We analyse cases spontaneously reported to the French pharmacovigilance. METHODS: Cases of psychiatric adverse effects with fluoroquinolones reported to the French pharmacovigilance system were analysed. The studied period was from January 1985 and June 2002. Data analysed included age, sex, adverse effect, fluoroquinolone, seriousness and evolution. RESULTS: Five hundred ninety cases have been reported concerning 273 males and 316 females (sex unknown in 1 case). Mean age was 66 years (median: 70, range: 12-102). The most frequently reported psychiatric adverse effects were confusion (51%), hallucinations (27%), agitation (13%), delusion (12%), insomnia (8%), somnolence (4%) (several adverse effects could be associated in a single patient). Serious cases represented 21.7% (resulting in hospitalisation in most cases). Evolution was favourable in most cases (88.5%), and was unknown in 9.5% of cases. CONCLUSION: The number of cases reported during this period is moderate, but under-reporting probably interferes. The eventuality of this kind of adverse effect with fluoroquinolones should be kept in mind. Dose should be adjusted to renal function, especially in older patients.

Adolescent↗
PubMed2004

Symptomatic bone disorders in HIV-infected patients: incidence in the Aquitaine cohort (1999-2002).

BACKGROUND: Since the inception of highly active antiretroviral therapy (HAART), mortality among HIV-infected patients has decreased, but this has been accompanied by the appearance of several complications. OBJECTIVES: To estimate the incidence of symptomatic bone disorders in HIV-infected patients of the Aquitaine cohort (from south-west France) for the period 1999-2002, and to describe cases. METHODS: We retrospectively studied the records of 2700 patients of the Aquitaine cohort, which was derived from a hospital-based surveillance system of HIV infection in France. All cases of symptomatic bone disorders diagnosed from 1 January 1999 to 30 June 2002 were reviewed. RESULTS: Fourteen cases of bone disorders were diagnosed, eight cases of aseptic osteonecrosis and six cases of severe osteoporosis, representing incidences of 0.3/1000 patient-years [95% confidence interval (CI): 0.14-0.62] and 0.22/1000 patient-years (95% CI: 0.09-0.52), respectively. All patients with aseptic osteonecrosis were male, while all but one with osteoporosis were female. The ages of patients ranged from 36 to 54 years for osteonecrosis and from 39 to 50 for severe osteoporosis. At the time of clinical diagnosis, all patients were treated with nucleoside reverse transcriptase inhibitors (duration of treatment ranging from 19 to 123 months for osteonecrosis and from 46 to 132 months for severe osteoporosis). Ten patients were treated with nonnucleoside reverse transcriptase inhibitors [duration of treatment ranging from 6 to 31 months for osteonecrosis (n=6) and from 4 to 29 months for severe osteoporosis (n=4)]. Thirteen patients were treated with protease inhibitors [duration of treatment ranging from 12 to 62 months for osteonecrosis (n=8) and from 3 to 44 months for severe osteoporosis (n=5)]. All osteonecrosis and five osteoporosis patients had at least one known risk factor or comorbidity associated with the bone disorder occurrence. CONCLUSIONS: In our study, the aetiology of clinical bone disorders seemed to be multifactorial, as almost all the patients had at least one possible risk factor in addition to HAART exposure.

Adult↗
PubMed2003

Accuracy of self-report and toxicological assays to detect substance misuse disorders in parasuicide patients.

OBJECTIVE: To assess the accuracy of self-reported substance use and toxicological assays in subjects admitted for Intentional Drug Overdose (IDO), using as a reference diagnosis of substance use disorder. METHOD: Self-reported substance use was collected and toxicological assays were carried out in urine samples in 507 patients with IDO. A standardized psychiatric evaluation was performed in 100 randomly selected subjects. RESULTS: In routine practice, the emergency department staff did not investigate substance use in nearly one of two patients. Patients' statements and toxicological assays were more specific than sensitive, with lower scores for toxicological assays. Patients' statements made it possible to detect nearly 80% of subjects with substance use disorder. CONCLUSION: Identification of substance use disorder in subjects with IDO has strong clinical consequences regarding treatment and prevention of suicidal behaviour. Thus, emergency department staff should be made aware of the value of more systematically exploring self-reported substance use.

Adolescent↗
PubMed2003

[Analysis of generic drug supply in France].

BACKGROUND: The list of generic medicines (LGM), published since 1997 by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFFSSaPS), the French Medicine Agency, concerns a special part of the medicines reimbursed by the National Health Insurance (Social Security). The objectives of the present study were: i) to describe the components of this list, based on pharmaceutical, economical and therapeutic characteristics, ii) to study differences between generic and reference products (formulations, excipients, prices, etc.), iii) to analyze information on excipients provided to health care professionals. METHODS: The 21st version of the LGM (April 2001) was used. Therapeutic value was retrieved from the 2001 AFSSaPS report on the therapeutic value of 4490 reimbursed medicines. Information on excipients in the LGM and the Vidal dictionary (reference prescription book in France) was compared. RESULTS: The products included in the LGM represent 20% of all reimbursed medicines. The mean price differences between generics and their reference products vary between 30 and 50% for more than two thirds of the generic groups. The therapeutic value of the products of the LGM was judged important in 71% of cases (vs 63% for the 4409 assessed medicines) and insufficient in 13% of cases (vs 19%). Information on excipients is often missing and sometimes erroneous. CONCLUSION: Although the LGM is regularly revised and thus the generic market in perpetual change, the 2001 cross description of this pharmaceutical market provides much informations and raises some concern.

Chemistry, Pharmaceutical↗
PubMed2001

Incidence of serious adverse drug reactions in general practice: a prospective study.

BACKGROUND: Many studies have been conducted to estimate the incidence and economic impact of adverse drug reactions. Most of these studies used historical data or were based on single hospital units. Little is known, however, about the frequency of serious adverse drug reactions in general practice. OBJECTIVE: To estimate the incidence of serious adverse drug reactions in the community. METHODS: A prospective study during 5 consecutive working days between March 1 and April 30, 1998, was conducted among a random representative sample of 254 general practitioners in Aquitaine, France. The main outcome measure was the number of serious adverse drug reactions (ie, resulting in death, life-threatening condition, hospitalization, incapacity, or sequel) observed by each general practitioner during the study period and validated by an expert panel. RESULTS: Thirteen validated serious adverse drug reactions, 2 of which were fatal (1 subarachnoidal hemorrhage with oral anticoagulant and 1 aplastic anemia with antineoplastics), were observed, resulting in an incidence density of 10.2 (95% confidence interval [CI], 5.4 to 17.5) per 1000 days of practice. Eleven case subjects (84.6%) were hospitalized. This represents an average of 2.6 cases per general practitioner per year, and 123,000 adverse drug reaction cases (95% CI, 65,400 to 210,000) for the 60,000 general practitioners in France. Antineoplastics and anticoagulants were the drugs most frequently involved, and blood dyscrasia and bleeding were the most frequent adverse drug reactions. CONCLUSION: This study, which is one of the few available that has prospectively measured the incidence of serious adverse drug reactions in general practice settings, confirms that serious adverse drug reactions are a major public health concern.

Adolescent↗
PubMed2000

[Acute renal failure after polyvalent immunoglobulin therapy].

BACKGROUND: Acute renal failure can be induced by intravenous administration of immunoglobulins, especially in patients with a predisposition for nephrotoxicity. The onset and resolution of acute renal failure is typically rapid, but in some cases hemodialysis may be needed. CASE REPORT: We present 2 cases of acute renal failure associated with intravenous immunoglobulin therapy: a 76-year-old man with a history of non-insulin-dependent diabetes mellitus and hypertension and a 77-year-old woman using nonsteroidal antiinflammatory drugs. DISCUSSION: Intravenous immunoglobulins must be used with precaution in patients with risk factors for acute renal failure. In such patients, renal failure may be avoided by using preparations without sucrose.

Acute Kidney Injury↗
PubMed2000

[Incidence and prevalence of adverse drug reactions].

FUNDAMENTAL DATA: Estimation of incidence and prevalence rates of adverse drug reactions are necessary to assess the consequences and impact of these effects in a population. HOSPITAL STUDIES: During the last 20 years, several studies conducted in one or more departments of a single hospital have found incidence of hospitalizations induced by adverse drug reactions between 2 and 8%. Three meta-analyses confirm these reports with incidence varying from 4.4 to 5.8% in different countries and from 5.2 to 8.2% and from 2.37 to 3.6% in the United States and Australia respectively. Two recent studies conducted by the French pharmacovigilance regional centers on a representative sample of medical departments in public hospitals found a prevalence of adverse drug reactions between 4.2 and 22.1% (according to the type of department and hospital) and a hospitalization incidence due to adverse drug reaction between 2.37 and 4.01%. COMMUNITY STUDIES: In community medicine, few data are available. In general medicine, the incidence would be 1.99 adverse effects per general practitioner per day. The number of serious adverse drug reactions has been estimated at 0.01 per general practitioner per day. These numbers show the magnitude of adverse drug reactions in terms of morbidity and mortality.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

[Drug information and prescription guidance: role of regional centers of pharmacovigilance].

MISSIONS: Drug information is one of the missions of the French Regional Pharmaco-Vigilance Centers together with the evaluation of adverse drug reaction (ADR) reports, expertise, teaching and research. SERVICES: Physicians and other health professionals call their regional center (the address and phone numbers are on the first pages of the Vidal, the French national drug compendium) for any kind of information pertaining to adverse drug reactions or proper use of drugs such as drug use in pregnancy or lactation. RELIABILITY: This information activity is successful because of the competence and impartiality of the regional centers which are based in university hospitals under an agreement signed with the French Medicines Agency.

Adult↗
PubMed2000

[Maintenance treatment for opioid dependence in care centers: the OPPIDUM program of the Evaluation and Information Centers for Drug Addiction].

The aim of this study was to analyze information concerning multiple drug addiction, illicit behaviors and use of the venous route by maintenance treatment patients included in the October 1998 survey of the OPPIDUM program. Among 1,462 observations, 71% of the subjects were taking maintenance treatments (60% high-dose buprenorphine and 40% methadone). High-dose buprenorphine was taken without medical supervision in 10% of cases. Indicators of abuse were high in this case: multiple drug addiction and intravenous use of buprenorphine (28%). Patients maintained by methadone were older and living in better socio-economic conditions than patients maintained by high-dose buprenorphine. However, in the two groups, the percentage of patients using the intravenous route was the same (15% and 21%). More cocaine was used by the methadone group (16% versus 7%). Thirty-seven percent of the subjects maintained on high-dose buprenorphine were followed by a general practitioner. They appeared to be more unbalanced and in more precarious condition than subjects treated in specialized care centers but they were not representative of the patients maintained by buprenorphine. It would be important to determine why these subjects consult a specialized care center.

Adult↗
PubMed1998

Spontaneous reporting of adverse drug reactions: who reports and what?

A survey among Bordeaux pharmacovigilance centre 'users' and 'non-users' was conducted in Aquitaine, France. Two hundred physicians having reported to the centre at least one adverse drug reaction (ADR) during the past 3 years were matched to a randomly selected sample of 400 physicians who did not report. They were asked to anonymously fill out a postal questionnaire collecting data on their individual characteristics, including their practice mode, and on ADRs that they observed and reported during the past 12 months. The number of questionnaires returned was 151 (25%), of which 76 were from users (38%) and 75 from non-users (19%). The two groups had very close individual characteristics. All but three responders had observed at least one ADR during the past 12 months. For the different types of ADRs defined in terms of seriousness and labelling, more users had seen ADRs than non-users but among those who observed them, the numbers of ADRs seen were similar in both groups. In any case, the more recent the drug, the more prone to report were the physicians.

Journal Article↗
PubMed1997

Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system database.

AIMS: To test the existence of an association between reports of hypoglycaemia and angiotensin converting enzyme inhibitors, in a spontaneous reports database. METHODS: The French Pharmacovigilance database was examined for an association between adverse drug reaction reports mentioning hypoglycaemia, and angiotensin converting enzyme inhibitors (ACEI) using the case/non-case methodology, with reports of hypoglycaemia as cases and all other reports as comparators. The association between ACEI or other chosen drugs and hypoglycaemia was also tested in the subgroups of patients taking or not antidiabetic agents (ADA). RESULTS: 428 of 93,338 reports mentioned hypoglycaemia (202/2227 with ADA (OR 40, 95% CI 33-48)). 46/5717 reports mentioned ACEI (OR 1.8 (1.25-2.54)). Other study drugs associated with hypoglycaemia were cibenzoline (OR 80 (57-112)), disopyramide (OR 32 (22-46)), nifedipine (OR 2.16 (1.32-3.51)), diltiazem (OR 1.76 (1.01-3.06)) nitrates (nitroglycerin, molsidomine) (OR 1.91 (1.16-3.16)) and frusemide (OR 1.89 (1.31-1.76)), but not nicardipine, amlodipine, felodipine or nitrendipine, diazepam, atenolol or combination thiazide diuretics. However, ACEI and other drugs were associated with ADA, so that in the subgroups of patients taking or not ADA, the association of ACEI with hypoglycaemia disappeared (OR 0.9 (0.5-1.4) and 1.2 (0.7-2.2), respectively). The same was found for other drugs except cibenzoline. CONCLUSION: The association between reporting of hypoglycaemia and ACE inhibitors was related to concomitant use of antidiabetic agents. This was true also for other drugs used in arterial disease or renal failure, such as calcium channel blockers, nitrates, and frusemide.

Adverse Drug Reaction Reporting Systems↗
PubMed1997

Under-reporting of adverse drug reactions in general practice.

AIMS: In post-marketing setting, spontaneous reporting by physicians is a mode of surveillance of adverse effects associated with drug use. The objective of this study was to quantitatively assess under-reporting of adverse drug reactions (ADRs) in general practice. METHODS: A random sample of 100 general practitioners (GPs) practising in the region of the Bordeaux pharmacovigilance centre were surveyed to obtain data on adverse effects observed. Overall, 81 GPs agreed to record during 3 non-consecutive working days any effect they believed to be associated with drug use. The types of effects, regardless of their seriousness and labelling, and the drugs suspected were characterized and compared to spontaneous reports received from GPs by the Bordeaux pharmacovigilance centre during the reference period. RESULTS: The average number of ADRs observed per day per GP was 1.99. The estimate of the under-reporting coefficient (U) was 24,433 (95% confidence interval: 20,702-28,837) which indicates that, as a whole, GPs might be expected to report only 1 out of every 24,433 ADRs to the pharmacovigilance centre. Under-reporting was lowest for serious and unlabelled effects (U = 4610; 95% CI: 2514-8454) and for drugs marketed recently (U = 12,802; 95% CI: 8174-20,050). CONCLUSIONS: Adverse effects due to drugs are part of GPs routine activities. According to the observed trend in under-reporting, there appears to be a selection process which indicates that spontaneous reporting in general practice is not conducive to an exhaustive description of the safety profile of a drug. However, our findings are consistent with greater efficacy of spontaneous reporting in detecting serious and unlabelled effect.

Adverse Drug Reaction Reporting Systems↗
PubMed1997

Temporal trends in spontaneous reporting of unlabelled adverse drug reactions.

AIMS: Trends in spontaneous reporting during the first years on the market were analyzed from a sample of selected drugs, with special attention to unlabelled effects. METHODS: Ten drugs were selected giving rise to approximately 100 spontaneous reports each during the first 4 years of marketing. Case reports were identified from the national pharmacovigilance database. A bibliographical score assigned at the time of reporting was used to identify unlabelled effects. Results were expressed as reporting rates. RESULTS: The average reporting rate peaked during the first year of marketing (54.6 per million treatment-months; s.d.: 62.8), then progressively decreased during the following years. Unlabelled effects effects represented 63% of all the spontaneous reports during the first year. CONCLUSIONS: Unlabelled adverse effects represent a high proportion of spontaneous reports during the early years of marketing.

Adverse Drug Reaction Reporting Systems↗