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Biomedical subjects

L M Gifford

Publications and source records attributed to L M Gifford.

4 recordsLinked to original sources
PubMed1995

Clinical safety of gadopentetate dimeglumine.

PURPOSE: To quantify the rate of adverse reactions to gadopentetate dimeglumine. MATERIALS AND METHODS: Magnetic resonance (MR) imaging was performed in 15,496 patients in April-September 1992. Data were collected before and after intravenous administration of 0.1 mmol/kg gadopentetate dimeglumine. RESULTS: Adverse reactions occurred in 2.4% (n = 372) of patients. Symptoms abated the same or next day in 94.1% (n = 350). Whereas onset occurred within 30 minutes after injection in 49.7% (n = 185), onset occurred more than 1 hour after injection in 44.9% (n = 167). Two serious adverse reactions occurred and were attributed to underlying disease. The rate of adverse reaction was 3.7% in patients with a history of asthma (31 of 831 patients) or allergy (144 of 3,860 patients). Patients with previous reactions to an MR imaging or iodinated contrast agent had an adverse-reaction rate in this study of 21.3% (16 of 75) and 6.3% (54 of 857), respectively. The rate of adverse reaction was 2.2% when gadopentetate dimeglumine was administered slowly and 2.9% when it was administered rapidly. CONCLUSION: Findings confirm the safety of gadopentetate dimeglumine.

Asthma↗
PubMed1984

A unique postmarket outpatient surveillance program of cimetidine: report on phase II and final summary.

A unique outpatient surveillance program consisting of an initial phase (phase I) and a follow-up phase (phase II) was initiated 7 months after FDA approval of cimetidine. The methodology used in this extensive postmarket surveillance program provided information on adverse effects in a large number of patients both on an acute and chronic (up to 12 months) basis. Phase I gathered data on 9907 patients from 1049 physicians over a 3-month period. The overall incidence of adverse effects in this phase was 4.4%, and they did not differ in type from those of premarketing controlled studies. Six months after termination of phase I, phase II was initiated, and follow-up data were requested on the same group of patients from the same 1049 physicians. Case report forms were received from 905 physicians on 7248 patients representing 9763 courses of cimetidine therapy. A total of 162 adverse effects were reported by 138 patients for an incidence of 1.8%. As in postmarket surveillance I, the adverse effects reported in postmarket surveillance II were not different from those previously reported in clinical studies, published reports, or via the spontaneous reporting system. This postmarket surveillance program designed and successfully tested methodology useful for future surveillance studies, and confirmed the safety of cimetidine in a large cohort of patients which remains a valuable source for future data accumulation.

Adolescent↗
PubMed1980

Cimetidine postmarket outpatient surveillance program. Interim report on phase I.

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.

Adolescent↗