Mortality adverse events

An analysis of the rates of serious cardiovascular adverse events (mortality, myocardial infarction, thrombotic strokes) in clinical studies involving tadalafil indicated that adverse events were no more frequent than in the general population of men with erectile dysfunction. ... 

Centers for Disease Control and Prevention Gamma hydroxy butyrate use—New York and Texas, 1995-96. JAMA 277 1511, 1997 Centers for Disease Control and Prevention Adverse events associated with ingestion of gamma-butyrolactone—Minnesota, New Mexico, and Texas, 1998-1999. MMRW Morb Mortal Wkly Rep 48 137-140, 1999 Chatlos JC Recent trends and a developmental approach to substance abuse in adolescents. Child Adolesc Psychiatr Clin N Am 5 1-27, 1996... 

Monitoring for efficacy, adverse events, and adherence to therapy is key to achieving the long-term goals of reducing the risk of morbidity and mortality associated with cardiovascular disease. 

Two recent meta-analyses add fuel to this controversial area.8,9 Decreases in infection-related mortality and gramnegative bacteremia were demonstrated with the use of quinolones, but overall adverse events were higher, and most of the studies were conducted in patients with hematologic... 

The WHO system, created in response to the thalidomide disaster, seeks to capture worldwide adverse events and identifies problems (WHO, 1975 Olsson, 1998). It is proposed that all such gathered reports should first be analyzed for mortality effects and trends (Rose and Elnis, 2000) as such would identify the most critical trends and be easiest to evaluate. 

In an audit in Auckland there was no increase in perinatal mortality or pre-eclampsia (115). The MIG prospective randomized comparison of metformin and insulin aims to recruit 750 women 70 have been recruited so far without serious adverse events in the metformin arm. 

The DPDP ligand was synthesized in order to lower the toxicity of the man-ganese(II) ion and to provide selective tissue uptake [40]. The LD50 of an i.v. dose of Mn-DPDP is between 1.9-5.4 mmol kg1 in mice [18, 41]. No mortalities occurred in dogs injected i.v. with 1.8 mmol kg-1 [41]. With the recommended clinical dose of 0.005 mmol kg1, the safety factor for Mn-DPDP is at least 360 [41]. In the European phase III clinical trials adverse events were reported for 46 of 624 patients (7%) [42]. In comparison, 123 of 546 patients (23%) in the U.S. clinical trials reported at least one adverse event [43]. In both trials the most common complaints were headache, vomiting and nausea. In addition, 377 of 546 patients (69%) in the U.S. trials and 26 of 624 patients (4%) in the European trials reported discomfort at the site of injection. The difference between the two trials is likely due to the method of administration and formulation of the Mn-DPDP solution. In the European trials, a 0.010 mM solution of the agent was slowly infused while in the U. S. trials Mn-DPDP was administered as a bolus injection of a 0.050 mM solution. Experiments have demonstrated a lower incidence of adverse events with infusion of the agent [44]. 

Adverse Events Associated with Ingestion of Gamma-Butyrolac-tone Minnesota, New Mexico, and Texas, 1998-1999. Morbidity and Mortality Weekly Report 48 (February 26, 1999) 137-140. 

In a small subset of CLASS (95 patients) mortality at 90 days was 19% in the clomethiazole group and 23% in the placebo group (5). Sedation was the most common adverse event (clomethiazole 53%, placebo 17%), followed by rhinitis and coughing. The incidence and pattern of serious adverse events was similar between the groups. 

An observational comparison in a rural Ghanaian hospital of 2083 pregnant women and 3084 historical controls showed no serious adverse events with chloroquine chemoprophylaxis (300 mg/week), but a high rate of pruritus (34). There was a decrease in anemia in pregnancy but no increase in perinatal mortality or birth weight in the chloroquine-treated mothers, although this was only in comparison with historical controls. 

Palpitation, tachycardia, and dizziness were additional events that occurred more often in cUostazol-treated patients and were considered to be probably related to treatment. Headache led to withdrawal of cUostazol in 3.5% of patients, and palpitation and diarrhea led to withdrawal in another 1%. All adverse events quickly resolved after withdrawal. Cardiovascular and all-cause mortality were similar with cilostazol and placebo. 

Centers for Disease Control and Prevention (CDC). Update adverse events associated with anthrax prophylaxis among postal employees— New Jersey, New York City, and the District of Columbia metropohtan area, 2001. MMWR Morb Mortal Wkly Rep 2001 50(47) 1051M. 

The use of a lower dose of enoximone in 105 patients with heart failure (New York Heart Association classes 2 or 3) has been studied over 12 weeks (12). Enoximone 25-50 mg tds improved exercise capacity and reduced dyspnea. There was no evidence of a dysrhythmic effect. The rates of adverse events were similar with enoximone and placebo, and there were fewer cases of dizziness, vertigo, or hypotension in those who took enoximone. There were two deaths in the 70 patients who took enoximone compared with four of the 35 who took placebo. However, this small short-term study does not rule out the possibility that even this small dose of enoximone can cause increased mortality during long-term administration or in patients with more severe cardiac failure. 

SurveiUence for safety after immunization Vaccine Adverse Event Reporting System (VAERS)-United States, 1991-2001. MMWR Morb Mortal Wkly Rep 2003 52(SS-1) 1. 

Adverse drug effects represent a major source of morbidity and mortality and must be considered in the differential diagnosis for patients who are experiencing new medical problems or whose chnical status is worsening. Familiarity with (3-lactam induced adverse reactions can improve antibiotic selection and reduce adverse events. Before antibiotic therapy is started, the potential benefits and the possible adverse effects should be investigated in hght of each patient s situation. Prevention should be considered in the first place, but if adverse events do occur, they must be recognized and corrected promptly. 

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