Global adverse events

Asian patients have been proposed to be at higher risk of SIADH during treatment with vincristine. Between 1983 and 1999, 76 cases of hyponatremia and/or SIADH related to the use of vincristine were reported to the global adverse event database of Eli Lilly and Company. The average age of the patients was 36 years (range 2 weeks to 86 years) and 62% were male. Most of the patients had received vincristine for leukemia or lymphomas. Of the 76 reports, 39 included background information on race 35 patients were Asian, three were Caucasian, and one was black. The authors concluded that there may be a correlation between race and vinca alkaloid-associated SIADH/hyponatremia however, the reasons are still unclear (1198). 

Underreporting of adverse events of medication is a global phenomenon. It applies to prescription and over-the-counter medicines and undoubtedly the same is likely to be true for CAM treatments. However, manufacturers of alternative treatments do not provide ongoing monitoring of the safety of their products that is comparable to that of pharmaceutical companies. 

Vaccination against infectious illnesses provides unseen protection against contagious diseases—afflictions causing permanent disability or even death. Vaccines have been responsible for dramatic decreases in morbidity and mortality secondary to infectious disease, and in the case of smallpox, has globally eradicated a once life-threatening illness.However, while true adverse consequences of vaccination have never exceeded the level of adverse consequences of infection in the absence of vaccination, the public perception of harm secondary to vaccine administration has threatened to overshadow the victory of disease prevention.With the inception and continued evolution of immunization, the number of individuals protected against diseases has steadily increased. Unfortunately, the number of vaccine-related adverse events has also increased proportionally to vac-... 

VC th this kind of classification in mind, how can a sponsor (or anyone else interested) assess whether an adverse event is associated with a particular medicine Broadly, there are two approaches - global introspection and use of algorithms. Both rely on the application of logic to the set of circumstances presented. Global introspection is most frequently used and involves one or more experts considering the factors associated with the medicine and institution. The main factors to consider are ... 

On May 19, 2004, docetaxel was approved for the treatment of metastatic prostate cancer. The approval was based on the TAX327 study, a randomized, multicenter global clinical trial enrolling over 1000 men with metastatic, hormone-refractory prostate cancer. The study compared docetaxel 75 mg/m every 3 weeks and prednisone 5 mg twice a day with docetaxel 35 mg/m weekly five out of six weeks and prednisone 5 mg twice a day and mitoxantrone 75 ng/m every 3 weeks and prednisone 5 mg twice a day. Docetaxel, in combination with prednisone, given every 3 weeks showed a survival advantage of approximately 2.5 months over the control group in the trial p =. 009). The most common adverse events reported were nausea, alopecia, and bone marrow suppression. In addition, fluid retention and peripheral neuropathy, known effects of docetaxel, were... 

All 52 patients received a unit dosage of lOOmg/day of kava extract. The treatment duration varied across subjects, with a mean of about 51 days across the total sample. The patients rated their treatment outcome on the Global Improvement Scale using a five-point rating system. Physicians rated the three target symptoms (anxiety, tension, and restlessness) on a four-point scale not present, mild, moderate, and severe. In addition, information on adverse events was obtained through a questionnaire. 

A hematoma was reported in one patient who underwent placement of a total endoprosthesis in the right knee. After three bolus infusions of rAHF-PFM, the adverse event resolved completely. The global assessment of efficacy was good at time of discharge, and no further adverse events were reported in this patient. 

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