Prevalence of fatal adverse drug reactions in hospitalized patients.

OBJECTIVE: The aims of the present study were to assess the prevalence of fatal adverse drug reactions (FADRs) in a hospitalized population, identify the drugs involved and investigate reported risk factors for these events. METHODS: The study population of this retrospective, single-centre case study comprised 289 patients dying between 1 January 2004 and 31 December 2004 and registered in the Cause of Death Register of a teaching hospital. All compiled data were recorded by two observers especially trained to identify and report adverse drug reactions (ADRs). The degree of probability that the ADR led directly to death was determined by using WHO criteria and an adapted version of Naranjo's score. RESULTS: Among 289 deceased study subjects, 17 (5.9%) were suspected to have died from an ADR. The most common suspected FADRs were gastrointestinal hemorrhages (52.9%), central nervous system hemorrhages (17.6%), cardiac disorders (17.6%), drug-induced myelosuppression (6%) and antimicrobial-related enterocolitis (6%). The drugs most frequently implicated in a FADR were antithrombotic drugs (65%), nonsteroidal anti-inflammatory drugs (NSAIDs) (47%) and corticosteroids (29%). The only risk factors associated with FADRs in this population were multiple-drug therapy and the presence of platelet antiaggregants and NSAIDs, alone or associated. CONCLUSIONS: FADRs are an important cause of death in hospitalized patients. Hemorrhages were seen in a majority of the fatal reactions, and antithrombotic agents or NSAIDs were implicated in most of these events.

Comparison of the efficacy and safety of two preseasonal regimens of glutaraldehyde modified, tyrosine-adsorbed parietaria pollen extract over a period of three years in monosensitive patients.

The purpose of this study was to evaluate the clinical efficacy over a period of three years (1988-90) of two preseasonal dosage regimens of a Parietaria allergoid (Bencard Tyrosine Parietaria) in patients who were only sensitive to this pollen. Fifty patients were included (14 men and 36 women, age: mean, 28 years; range, 14-47 years). Twenty five patients (group A) were treated each january with the basic course of Bencard Tyrosine Parietaria. This consisted of injecting subcutaneously 0.5 ml from each of three vials, with one week between each injection. A further injection using the vial with the highest dose was given one week later. Each january and february, twenty five patients (group B) were treated with the basic course of Bencard Tyrosine Parietaria, repeating the last dose five times, with one week between each injection. Immunotherapy with a tyrosine-adsorbed Parietaria judaica allergoid is an effective method for mitigating nasal (p < 0.0001), bronchial (p < 0.005), conjunctival (p < 0.001) and palatal itching symptoms (p < 0.0001) in patients who are sensitive to this pollen. Sensitivity to Parietaria pollen, as verified by skin test and nasal challenge, decreased during immunotherapy (p < 0.001). Histamine release by peripheral blood basophils decreased during the course of the study, falling from 43.5 ng/ml to 12.3 ng/ml in group A and from 42.9 ng/ml to 10.0 ng/ml in group B; during the second and third years, IgG levels were increased one and four months after starting treatment with the extract, while this was not the case after ten months; IgE levels were also increased. Finally, overall tolerance to this immunotherapy product was good in almost all patients.