Number of patients treated with zidovudine in the limited distribution system, March-September, 1987.
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Biomedical subjects
Publications and source records attributed to E B Andrews.
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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.
Two companion post-marketing studies have evaluated the frequency of adverse events amongst patients receiving atracurium. In this second report, we describe the Scottish study and discuss findings in both centres. In this study we compare the frequency of adverse events in 477 patients receiving atracurium with those in 484 patients who received vecuronium. The frequency of reported serious adverse events was low during surgery and in the recovery room. Although the overall incidence of adverse experiences was slightly lower after atracurium, there were no significant difference between the groups in frequency of major adverse events. This type of study is believed to be of value in the future surveillance of new drugs for hospital use.
Observational epidemiologic methods are being used to evaluate the safety of acyclovir in pregnancy. An essential component of this research is the establishment of a baseline expectation of pregnancy outcomes among women with herpes not receiving acyclovir. Continuing studies will be described in this report. To supplement these structured studies, an international case registration study was established. Through the Acyclovir in Pregnancy Registry, all cases of reported prenatal exposures to acyclovir are tracked to ascertain maternal exposure, risk factor, and pregnancy outcome information. The reports originate in all countries where oral acyclovir is marketed; data consolidation and analysis are coordinated at Burroughs Wellcome Co. with the assistance of a government/industry advisory panel. This presentation summarizes provisional data from the prospective reports, including trimester of exposure and reported outcomes of pregnancy. The total number of monitored pregnancies remains too small to support conclusions about the safety of acyclovir during pregnancy at this point. The potential for the registry and other epidemiologic studies to address the safety-in-pregnancy question will be discussed.
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