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Biomedical subjects

T Vial

Publications and source records attributed to T Vial.

At least 19 recordsLinked to original sources
PubMed2006

Myasthenia gravis exacerbation or unmasking associated with telithromycin treatment.

Telithromycin, a new ketolide antibiotic, has been implicated in the exacerbation or unmasking of myasthenia gravis. This retrospective study presents two clinical reports and summarizes eight other suspected cases notified to the French pharmacovigilance system, highlighting a potentially life-threatening risk of telithromycin treatment in myasthenic patients. An important common feature was that, in seven cases, symptomatology occurred within 2 hours of first telithromycin intake--notably in cases of severe exacerbation.

Adult↗
PubMed2006

[Ambroxol-induced immune hemolytic anemia].

INTRODUCTION: Drug-induced immune hemolytic anemia is a rare cause of hemolytic anemia. CASE RECORD: A 68-year-old male patient developed an acute intravascular hemolysis with acute renal failure. Common causes of hemolysis were ruled out and the patient rapidly improved. An immune mechanism was confirmed by the positivity of the direct antiglobulin test with anti-IgA in the presence of ambroxol only, one of the drug the patient had received during 6 days before hospitalization. DISCUSSION: To our knowledge, this is the first report of ambroxol-induced immune hemolytic anemia. This case also underlined that the direct antiglobulin test should also be performed with anti-IgA to rule out any false negative.

Aged↗
PubMed2005

Carbimazole induced eosinophilic granulomatous vasculitis localized to the stomach.

Vasculitis associated with anti-neutrophil cytoplasmic antibodies has been reported in patients treated with anti-thyroid drugs and especially propylthiouracil. We report here a case of granulomatous eosinophilic vasculitis mimicking gastric neoplasm and peripheral eosinophilia in a 27-year-old man who was treated with carbimazole for 5 months for Graves' disease. Clinical and morphologic features resolved within 2 months after stopping the drug, suggesting a causative role for the drug. To our knowledge, this is the first biopsy-proven granulomatous eosinophilic vasculitis associated with this drug.

Adult↗
PubMed2004

Sideroblastic anaemia during fusidic acid treatment.

OBJECTIVES AND METHODS: To describe cases of fusidic acid-associated sideroblastic anaemia from the French Pharmacovigilance database. RESULTS: Six cases of sideroblastic anaemia associated with oral fusidic acid treatment were retrieved. Four females and two males (mean age 65.3 yr) developed severe anaemia (mean haemoglobin level: 6.9 g/dL) within 32-190 d (mean: 81 d) of treatment. Bone marrow aspirates showed dyserythropoiesis and ringed sideroblasts in all patients. Four patients required repeated blood transfusions. After fusidic acid discontinuation in five patients, complete recovery was obtained. In one patient, rechallenge with fusidic acid resulted in recurrence of anaemia that resolved after definitive discontinuation of the drug. CONCLUSION: Our data indicate that fusidic acid should be added to the list of drugs that can cause sideroblastic anaemia.

Aged↗
PubMed2002

Adverse effects of immunotherapeutics involving the immune system.

Immunotherapeutics are pharmaceutical products intended to modify immune functions either directly or indirectly by influencing physiological systems that affect immunological functions. They include conventional immunosuppressants, monoclonal antibodies, recombinant cytokines, gene therapy products or therapeutic vaccines. A variety of adverse effects involving the immune system have been described in laboratory animals as well as in the clinic. Some of these adverse effects can be predicted, at least to some extent, from the immunopharmacological profile of these drugs, but a number of unpredicted adverse effects have been described. Immunosuppression, allergy, autoimmunity, immunoactivation are the major adverse consequences to be expected as illustrated by this overview of the leading immunotherapeutics already used in the clinic. These untoward and potentially severe consequences support the need for a careful preclinical and clinical evaluation of the immunotoxicity of these products.

Adjuvants, Immunologic↗
PubMed2002

[Anaphylactic shock associated with ceftriaxone therapy in a newborn].

CASE REPORT: During an hospitalization, a ten-day-old newborn infant was treated with ceftriaxone (Rocephine i.v., 390 mg/day) for an infection secondary to the presence of an umbilical catheter. A few minutes after the end of the fifth injection, the infant presented with cyanosis, initially localized at the perfusion site, then generalized, a tachycardia followed by acute circulatory failure with arterial hypotension and finally a multiple organe failure with coagulation, kidney and liver dysfunction. The infant received classical resuscitation treatment and recovered without short term sequelae. The time of onset was in favour of drug-induced accident. A postnatal sensitization during previous injections might have occurred, although the latency of immediate hypersensitivity reactions after a first sensitizing contact is usually longer. A sensitization in utero or via breast feeding was ruled out due to the absence of maternal exposure to ceftriaxone. The absence of urticaria and bronchospasm, and the initial localization of cyanosis were not in favour of a classic allergic disease. An other cause, toxic or infectious cannot be ruled out.

Anaphylaxis↗
PubMed2001

Drug allergy diagnosis in humans: possibilities and pitfalls.

Due to the potential hazards of drug allergies, an early and reliable diagnosis is crucial. The use of in vivo tests is not recent but, because of the hazards of skin testing in patients with a history of anaphylaxis, they had been abandoned for a while. Recent reevaluations have shown that for some drugs, e.g. antibiotics-reliable skin tests can ensure the diagnosis of drug allergy in up to 70% of cases. Many in vitro tests based on well-defined mechanisms, e.g. the basophil degranulation test have been used for the diagnosis of totally unrelated allergic mechanisms. It is almost impossible to interpret their validity as diagnosis tools. Nevertheless, other tests, e.g. the lymphocyte transformation test which have been evaluated in well-conducted recent studies, seem to have a good predictive value. Their use is still restricted to clinical trials or research studies. A reliable clinical approach as well as a detailed examination of the drug intake remains obligatory to diagnose drug allergy. Available in vivo and in vitro tests are sometimes used to confirm the diagnosis. The sensitivity and specificity of these tests is evaluated in clinical studies. Research to improve the existing tests and to develop new diagnostic tools is still of paramount importance.

Animals↗
PubMed2001

[Cutaneous adverse drug reactions: enhanced imputation score by skin testing].

INTRODUCTION: A careful diagnosis and the identification of the causative drug after a cutaneous adverse reaction can avoid relapses. Skin tests facilitate the identification of the causative molecule by producing a hypersensitivity reaction at the application site. Adverse drug reactions are reported to Pharmacovigilance Centres who determine the imputation score of the suspected drugs. The aim of this study was to assess to what extent skin testing after a suspected allergic drug reaction can be helpful to identify the causative drug and whether an impact on the final imputation score could be evidenced. METHOD: A 18-month prospective study was performed. All patients with a history of cutaneous adverse drug reaction of suspected immunoallergic origin were included provided skin tests could be performed within 6 to 12 weeks after the adverse drug reaction. The imputation score was determined using the French imputation method prior to and after skin testing. RESULTS: Thirthy-nine patients were included in the study. Positive skin tests were observed in 11 of 20 patients with a C2S2 (I2: plausible) initial imputation score and in 6 of 15 patients with a C2S1 (I1: doubtful) initial imputation score. One patient with a C1S1 (I1: doubtful) initial imputation score had positive skin tests. DISCUSSION: The results of skin tests helped change the imputation score of the suspected drug in 18 patients out of 39. In 55 p. 100 of cases, the imputation score was increased from C2S2 (I2) to C2S3 (I3: likely) and from C2S1 (I1) to C2S3 (I3) in 40 p. 100 of cases. The increase in imputation scores was helpful to improve warning signals after an immunoallergic reaction. Skin tests led to a more accurate diagnosis in 50 p. 100 of cases. Thus, more adequate advices for further drug treatment were possible, particularly in avoiding the irrelevant prohibition of innocent drugs.

Adolescent↗
PubMed2000

[Imputable cutaneous eruption caused by ticlopidine after implantation of a coronary endoprosthesis: why not continue treatment?].

BACKGROUND: The decision to interrupt a ticlopidine regimen in a patient who develops an adverse effect can be particularly difficult when discontinuing the drug could lead to a high risk situation. CASE REPORT: A 64-year old patient developed a skin rash after taking ticlopidine for coronary artery stenting. Stopping ticlopidine could have led to stent occlusion and no alternative therapy seemed to be suitable. We therefore decided to carry on the treatment under close clinical surveillance. The skin signs rapidly resolved. DISCUSSION: This cases shows that ticlopidine may be continued in patients who develop an adverse skin reaction. The rapid involution of the cutaneous signs in our patient demonstrated that the risk of discontinuing treatment can be greater than that of continuing.

Angioplasty, Balloon, Coronary↗
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

Endocrine and neurological adverse effects of the therapeutic interferons.

There is experimental evidence that the nervous central and the neuroendocrine systems can influence the immune system, which can in turn influence the brain activity. Endogenous cytokines are known to play a critical role in the pathophysiology of many diseases. The recently acquired experience on the adverse effects of therapeutic cytokines, particularly neurological and endocrine adverse effects, are further illustrative of these interferences. Interferons-alpha have been used in thousands of patients, so that the information accumulated with this group of closely related products is essential to delineate the potential and severity for non-immunological, but largely immune-mediated adverse effects to develop in patients treated with immuno-activating agents.

Animals↗
PubMed2000

Liver injury due to tetrabamate (Atrium): an analysis of 11 cases.

BACKGROUND: Tetrabamate (Atriums), widely used in the treatment of tremor and ethanol-withdrawal symptoms, has been incriminated as a potential cause of reversible acute hepatitis. OBJECTIVE: We report here on 11 patients who experienced tetrabamate-related liver injury, in order to evaluate their clinical, histopathological and evolutive features. PATIENTS AND METHODS: Between 1987 and 1998, 34 cases of tetrabamate-associated acute hepatitis were spontaneously reported to the regional pharmacovigilance center of Lyon. Eleven cases were considered probably to be drug-induced. RESULTS: There were three males and eight females aged 31-82 years (mean, 57 years). The duration of treatment ranged from 33 to 206 days, and indication for treatment was depressive disorders, tremor or prevention of alcohol withdrawal symptoms. Clinical symptoms were asthenia (n = 9), jaundice (n = 3) and/or diffuse rash (n = 3). The pattern of liver injury was cytolytic (n = 10) or cholestatic (n = 1). Three patients presented biological features of hepatic failure. A percutaneous liver biopsy was performed in six patients. Histological examination of the liver specimen showed a large spectrum of lesions: massive hepatocellular necrosis (n = 1), centrilobular and nonconfluent hepatocyte necrosis (n = 2), intracellular cholestasis (n = 3), and granulomatous hepatitis (n = 1). Tetrabamate was discontinued in all patients. In seven patients, a complete recovery was observed 3 weeks to 3 months after drug withdrawal. Two patients, despite a rapid improvement of liver function tests, died from unrelated causes. The remaining two patients died from irreversible hepatic failure. CONCLUSIONS: Our data strongly suggest that tetrabamate may induce acute liver injury, which may eventually result in life-threatening liver failure.

Adult↗
PubMed1999

Exposure to yellow fever vaccine in early pregnancy.

We report on a data collection concerning exposure to yellow fever vaccine (YFV) during early pregnancy, ascertained through the European Network of Teratology Information Services (TISs) and the Pharmacovigilance Department of Pasteur Merieux Connaught (PMC). Six TISs had had no inquiry about YFV. Five submitted prospectively collected cases. Seventy-four cases were analyzed, 58 with a completed follow-up. Pregnancies ended in 46 births, five voluntary abortions and seven spontaneous abortions. Three newborns had minor anomalies and two had major defects (ureteral stenosis and triphalangeal hallux). Although the sample is too small to rule out a moderate increased risk of adverse reproductive effect of YFV, it gives no argument for such an effect and should lead to reassure pregnant women who might be inadvertently vaccinated.

Congenital Abnormalities↗
PubMed1999

High vitamin A intake in early pregnancy and major malformations: a multicenter prospective controlled study.

The European Network of the Teratology Information Services (ENTIS) collected and evaluated data on 423 pregnancies exposed during the first 9 weeks of gestation to a "high" dose of vitamin A (10,000 IU per day or more). Data were collected prospectively; 394 women (93.1%) were followed by telephone interview up to the first few weeks after the expected date of delivery, using standardized procedures. The presence of major structural malformations, excluding chromosomal and genetic diseases, was evaluated in 311 infants exposed to a median daily dose of vitamin A of 50,000 IU per day (range, 10,000-300,000 IU per day; interquartile range, 25,000-60,000 IU per day). Three infants with a major malformation were reported: pulmonary stenosis, stenotic anus with fistula, and bilateral inguinal hernia. No congenital malformations were reported among 120 infants exposed to more than 50,000 IU per day of vitamin A. When the birth prevalence rate of major malformations in the study group was compared with two internal control groups of infants exposed to: 1) "high" vitamin A exposure later in pregnancy, and 2) nonteratogenic agent exposures, the rate ratio was, respectively, 0.28 (CI 95% interval, 0.06, 1.23) and 0.50 (CI 95% interval, 0.14, 1.76). The studied sample did not provide evidence for an increased risk of major malformations, associated with "high" vitamin A intake during the organogenetic period, higher than 2.76 above the control reference risk of 1.91% (power 80%, alpha 0.10).

Abnormalities, Drug-Induced↗