Patients adverse events

Data from 20 clinical studies in 5000 patients who had taken ranitidine bismuth citrate (200, 400, or 800 mg bd) have been reported (14). The incidence of adverse events was not different from that associated with placebo and was independent of dose. The most common events (>1% of patients) were upper respiratory tract infections, constipation, diarrhea, nausea, vomiting, dizziness, and headache, the last being the only event reported by over 2% of the patients. Adverse events considered by the chnical investigator to be adverse reactions occurred with a similar frequency amongst patients given ranitidine bismuth citrate (8%), ranitidine hydrochloride (6%), and placebo (6%). The incidence of adverse reactions was greater when amoxicillin (11%) or clarithromycin (20%) were co-prescribed. 

The effectiveness of gabapentin has been studied in 22 patients with bipolar disorder who had an incomplete response to other mood stabilizers (5). Somnolence was common (six patients) adverse events that occurred in two patients each included irritability, memory impairment, headache, and tremor. One patient dropped out because of a mild rash. 

In a systematic review of randomized controlled trials of pramipexole and ropinirole, dizziness, nausea, hypotension, hallucinations, and somnolence were common adverse effects (1). In 306 patients adverse events secondary to pramipexole that occurred in over 10% included... 

The organization has a nonpunitive policy to address patient adverse events involving medical staff and organization employees. 

The efficacy of vitamins C, E and their combination for treatment of restless legs syndrome in haemodialysis patients has been evaluated in an 8-week randomised, double-blind, placebo-controlled trial involving 60 stable patients. Adverse events included nausea and dyspepsia. No serious adverse events were reported [30 ]. 

Venlafaxine (48) is a stmcturaHy novel phenylethylamine derivative that strongly inhibits both noradrenaline and serotonin reuptake. It lacks anticholinergic, antihistaminergic, and antiadrenergic side effects. As compared to placebo, most common adverse events are nausea, somnolence, dizziness, dry mouth, and sweating. Venlafaxine-treated patients also experienced more headaches and nausea, but less dry mouth, dizziness, and tremor than patients treated with comparator antidepressants. 

Other agents are also used for the treatment of manic-depressive disorders based on preliminary clinical results (177). The antiepileptic carbamazepine [298-46-4] has been reported in some clinical studies to be therapeutically beneficial in mild-to-moderate manic depression. Carbamazepine treatment is used especially in bipolar patients intolerant to lithium or nonresponders. A majority of Hthium-resistant, rapidly cycling manic-depressive patients were reported in one study to improve on carbamazepine (178). Carbamazepine blocks noradrenaline reuptake and inhibits noradrenaline exocytosis. The main adverse events are those found commonly with antiepileptics, ie, vigilance problems, nystagmus, ataxia, and anemia, in addition to nausea, diarrhea, or constipation. Carbamazepine can be used in combination with lithium. Several clinical studies report that the calcium channel blocker verapamil [52-53-9] registered for angina pectoris and supraventricular arrhythmias, may also be effective in the treatment of acute mania. Its use as a mood stabilizer may be unrelated to its calcium-blocking properties. Verapamil also decreases the activity of several neurotransmitters. Severe manic depression is often treated with antipsychotics or benzodiazepine anxiolytics. 

In patients having Parkinson s disease, both entacapone and tolcapone potentiate the therapeutic effect of L-dopa and prolong the daily ON time by 1-2 h. In the clinic, COMT inhibitors have been well tolerated, and the number of premature terminations has been low. In general, the incidence of adverse events has been higher in tolcapone-treated patients than in entacapone-treated patients. The main events have comprised of dopaminergic and gastrointestinal problems [2,3]. 

Report SERIOUS adverse events. An event is serious when the patient outcome is ... 

In general, for smokers with cardiac disease, the benefits of nicotine replacement therapy outweigh the potential risks. In a safety and efficacy study that included veterans with cardiac disease, smoking concurrently with the nicotine patch was not associated with an increase in adverse events (Joseph et al. 1996). Although bupropion SR is generally well tolerated by smokers, it has not been adequately studied in persons with cardiac disease, and definitive conclusions regarding its safety in this patient population cannot currently be made (Society for Research on Nicotine and Tobacco 2003). 

Aleatory uncertainty —the roll of the die—describes risks that cannot practicably be predicted within the research process, for example, new failure modes, or modes that can only be detected in late stages of work, for example, humans. An example of aleatory uncertainty is the withdrawal in the UK of Bextra on the basis of two serious adverse events out of 40,000 patients this could only be discovered after launch [2]. This, without hindsight, was an uncontrollable risk. ... 

Reconfiguration of Data. Drug safety data from different sources are often pooled or combined in databases. Reasons for combining data vary. In the case of premarketing studies, data from different sites are routinely combined because one site may not be able to recruit enough patients for a study. Data from different studies are often combined to increase sample size and therefore statistical power for detecting an uncommon adverse event. 

Figure 27.2 A display that summarizes the duration of treatment (black sqnares) and the timing of serious vascular events (circles) for the subset of patients who withdrew from treatment because of an adverse event. Each line represents a single patient s experience over time in days for the test (left panel) and the control drug (right panel). Patients are sorted by decreased duration of treatment. In this 1 1 randomized clinical trial there were 18 withdrawals due to a severe vascular adverse event with the test drug. This is in contrast with the control drug, with 11 withdrawals. Withdrawals with the test drug occurred sooner than with the control drug.

Limited Knowledge of Exposure and Reporting Rates in Postmarketing Data. Unlike clinical trials and electronic medical records in clinical practice, postmarketing voluntarily reported data contain limited information about the total number of patients exposed and the duration of exposure. This problem is compounded by the fact that adverse events are often underreported [2,9]. 

Crucial factors affecting overall cost are the responsiveness to medication (for example, less than 70% of patients are lithium responders ), adherence to recommended treatment, and adverse events resulting from medication. A particular hazard of lithium treatment is the risk of rapid re-emergence of mania, which occurs in up to 50% of patients if the dmg is abruptly discontinued (see Cookson, 1997). Disappointingly, it has not been found that the introduction of widespread treatment with lithium has been associated with a reduction in the number of patients admitted and discharged from hospital with a diagnosis of mania. In order to achieve the best result with the available... 

Regrettably, all chemotherapeutic agents have the potential to produce adverse reactions with varying degrees of frequency and severity, and these include hypersensitivity reactions and toxic effects. These may be dose-related and predictable in a patient with a history of hypersensitivity or a previous toxic reaction to a drug or its chemical analogues. However, many adverse events are idiosyncratic and therefore unpredictable. 

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