Adverse events clinical significance

Psoriasis (Neoral or Gengraf only) - The initial dose of Neoral or Gengraf s 2.5 mg/kg/day. Take Neoral or Gengraf W ce daily, as a 1.25 mg/kg oral dose. Keep patients at that dose for 4 weeks or more, barring adverse events. If significant clinical improvement has not occurred in patients by that time, increase the patient s dosage at 2-week intervals. Based on patient response, make dose increases of approximately 0.5 mg/kg/day to a maximum of 4 mg/kg/day. 

Although mania has been associated with olanzapine (SEDA-24, 68 SEDA-25, 68 SEDA-26, 62), it has also been used in the treatment of acute mania. In a 12-week, double-blind, double-dummy, randomized trial, 120 patients with bipolar disorder type I hospitalized for an acute manic episode were randomly assigned to either sodium valproate (n = 63) or olanzapine (n = 57) and were followed in hospital for up to 21 days (60). Valproate and olanzapine had similar short-term effects on clinical or health-related quality of life outcomes in bipolar disorder adverse effects that occurred in a higher percentage of olanzapine-treated than valproate-treated patients included somnolence (47% versus 29%), weight gain (25% versus 10%), rhinitis (14% versus 3%), edema (14% versus 0%), and slurred speech (7% versus 0%) no adverse events occurred significantly more often with valproate. 

Tacrine (tetrahydroaminoacridine) was one of the first drugs to be widely marketed for the loss of memory and intellectual decline in Alzheimer s disease. However, its efficacy is controversial. A Cochrane review of the use of tacrine in Alzheimer s disease produced results that were compatible with improvement, no change, or even harm (1). For measures of overall clinical improvement, the intention-to-treat analyses did not detect any difference between tacrine and placebo (OR = 0.87 95%CI = 0.61, 1.23). There was no effect on behavioral disturbance (SMD = 0.04 95% Cl = -0.52,0.43) or cognitive function (SMD = 0.14 95% Cl = -0.02, 0.30). The odds ratio for withdrawal due to an adverse event was significantly different from 1, the control group experiencing fewer events (OR = 0.7 95%CI = 4.1, 7.9). Raised serum liver cnzym cs caused the most withdrawals. 

Headache, dizziness, and gastrointestinal symptoms are the most frequent adverse effects clinically significant gastrointestinal events include upper gastrointestinal ulceration, with or without hemorrhage or perforation (SEDA-20, 94) (SEDA-21, 107). The profile of drug interactions is similar to the profiles of other NSAIDs (SEDA-21,108). 

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects and analyzes information from reports of adverse reactions after immunization. Anyone can report to VAERS, and reports are sent in by vaccine manufacturers, health care providers, and vaccine recipients and their parents or guardians. An example of the VAERS and instructions for completing the form are found in Appendix F. Any clinically significant adverse event that occurs after the administration of any vaccine should be reported. Individuals are encouraged to provide the information on the form even if the individual is uncertain if the event was related to the... 

CrCl greater than or equal to 30 to less than 50 mL/minute) and severe (CrCl less than 30 mL/minute) renal impairment respectively. Renal function monitoring is recommended prior to initiation and periodically thereafter. Adverse events in clinical trials included nasopharyngitis (5.2%), upper respiratory tract infection (6.3%), and headache (5.1%). Currently, no significant drug interactions are known. 

Our human health depends on a balanced and buffered blood pH. For instance, human blood is slightly basic with a pH between 7.3 and 7.5. If the blood pH drops below 7.3, acidosis occurs. If the blood pH rises above 7.5, alkalosis occurs. Adverse events including death will occur if a significant change in the blood pH goes below 6.8 or above 7.8. pH levels in blood are frequently determined in clinical laboratories [145],... 

The safety of rifaximin, 200 mg 3 times daily, was evaluated more recently in 320 patients from two placebo-controlled clinical trials [34], All the adverse events for either rifaximin or placebo that occurred at a frequency > 2% are shown in table 14. With the exception of flatulence, which occurred significantly (p = 0.0071) less frequently after drug treatment, the adverse event profile of rifaximin overlapped that of placebo. 

As a result of these findings, a scheduled standard pelvic exploration is now an obligatory procedure in clinical trials with new SERMs. It is important to note that this adverse effect has not been associated with tamoxifen or toremifene therapy (Maenpaa et al. 1997 Fisher et al. 1998), and in the case of raloxifene, a post hoc metaanalysis of 6926 nonhysterectomized postmenopausal women participating in clinical trials for 3 years or more showed a significant 50% reduction in the incidence of surgery for repairing pelvic floor relaxation, reported as an adverse event, compared with placebo (Goldstein et al. 2001). 

In response to the National Childhood Vaccine Injury Act of 1988, which required health workers to report vaccine adverse events, the CDC and the FDA collaborated in 1990 to implement the Vaccine Adverse Event Reporting System (VAERS) to monitor the safety of vaccines in both sectors. Health care professionals and parent or other caretakers are encouraged to report all clinically significant vaccine adverse events. Narrative diagnostic reports are reviewed and assigned standard codes using Coding Symbols for a Thesaurus of Adverse Reaction Terms. The source of the vaccines (public versus private provider) is recorded on the form. 

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