Types Of Adverse Effects Research Articles

ATRACURIUM—A POST-MARKETING SURVEILLANCE STUDY: METHODS AND U.S. EXPERIENCE

Two companion post-marketing studies have evaluated the frequency of adverse events amongst patients receiving atracurium. In this first report, we describe the study methods used in both centres and the findings of the study conducted at the Group Health Co-operative of Puget Sound, U.S.A. In this study, the frequency of adverse events in 1013 patients receiving atracurium was substantially the same as that in 851 patients receiving other neuromuscular blocking agents. In both groups there were no instances of cardiac arrest, anaphylaxis or death, no adverse effects associated with failure to antagonize neuromuscular block, and no instances of previously unreported types of adverse effects. We conclude that the safety profile of atracurium is similar to that of other neuromuscular blocking agents and that this type of observational study of anaesthetic agents may prove a useful tool for surveillance of new drugs used primarily in hospitals.

Types of disposable medical devices reused in hospitals.

Rising health care costs have prompted hospitals to turn to reprocessing and reuse of disposable devices as a cost-saving measure. The safety, efficacy, and cost benefit of such a practice are largely unknown. Classification schemata are presented as a means of categorizing the reasons for reprocessing and the types of adverse effects that may result from reprocessing and reuse. The very limited literature on reuse of disposable devices is reviewed. Examples of the categories of reprocessing and adverse effects are provided from a review of the experience with reprocessing and reuse at a university medical center. With the rising pressure for containment of health care costs, it is likely that this practice will expand further. The practice of reprocessing and reuse should be subjected to scientific study.

Cutaneous reactions in head-injured patients receiving phenytoin for seizure prophylaxis.

Two types of adverse effects are caused by phenytoin, reversible dose-dependent central nervous system effects and non-dose dependent hypersensitivity effects. The most common presenting symptom of the hypersensitivity reaction is the development of a morbilliform rash. During a 45-month period, 151 head-injured patients received phenytoin for seizure prophylaxis using an 11-mg/kg i.v. and a 13-mg/kg i.m. parenteral loading dose followed by an i.m. or p.o. maintenance dose for therapeutic blood concentrations (10 to 20 micrograms/ml). The patients were followed for 18 months. The incidence of skin reaction to phenytoin was 19.4%, or 24 of 124 patients. Cutaneous reactions occurred from Day 5 through Day 91 of phenytoin therapy. Two patients had more serious reactions after the cutaneous reaction. One patient developed exfoliative dermatitis, and 1 had a pseudolymphoma type syndrome. Both recovered. Patients with cutaneous reactions had higher absolute eosinophil counts (P = 0.01). Other laboratory parameters of the white blood count and the total lymphocyte counts did not differ significantly. Patients receiving dexamethasone had a higher incidence of rash, but this did not reach statistical significance. Because recent data have not documented a seizure-prophylactic effect of phenytoin, only a head-injured patient who has experienced a first posttraumatic seizure should receive the drug.

Cimetidine Postmarket Outpatient Surveillance Program

A postmarket surveillance program in outpatients receiving cimetidine was initiated seven months after its approval for marketing. During the first phase of the program, data were obtained over a three-month period for 9,907 patients who received the drug. The overall incidence of adverse effects reported was 4.4%, and the types of adverse effects did not differ from those reported in premarketing controlled studies. Physician response was excellent (85.1%), and the methods used were successful in providing data on a large number of patients who received the drug in routine clinical practice. The results confirmed the safety profile of cimetidine. A follow-up phase, initiated six months after the initial phase of the surveillance program, will provide longer-term data on these patients.