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Biomedical subjects

J S Schou

Publications and source records attributed to J S Schou.

At least 19 recordsLinked to original sources
PubMed1997

Withdrawal reactions with selective serotonin re-uptake inhibitors as reported to the WHO system.

OBJECTIVE: The present study was performed both to investigate whether there might be a difference between the selective serotonin re-uptake inhibitors, (SSRIs) with regard to the incidence of withdrawal reactions, and to describe the associated symptoms. From the WHO database, therefore, all case reports from the year of introduction for each of the SSRIs, fluoxetine, paroxetine and sertraline, were retrieved. Sales figures were obtained from Intercontinental Medical Statistics International. The reporting rates were calculated as the number of reports per million defined daily doses (DDDs) sold per year. RESULTS: The reporting rate of withdrawal reactions for paroxetine was found to be higher than that for sertraline and fluoxetine in each of the countries selected for detailed analyses (US, UK and Australia), as well as for all 16 countries combined. Moreover, using the WHO system of organ classification, the ratio of central nervous system to psychiatric withdrawal symptoms was 1.9 and 2.1 for paroxetine and sertraline, respectively, whereas that for fluoxetine was 0.48, indicating a possible qualitative difference between the SSRIs with respect to the nature of the withdrawal syndrome.

1-Naphthylamine↗
PubMed1997

How does cystitis affect a comparative risk profile of tiaprofenic acid with other non-steroidal antiinflammatory drugs? An international study based on spontaneous reports and drug usage data. ADR Signals Analysis Project (ASAP) Team.

Series of well-documented case reports strongly suggest a causal association between tiaprofenic acid and a form of aseptic cystitis, which can cause serious and long-term morbidity if the drug is not withdrawn promptly. These findings are supported in the Australian and UK spontaneous reporting data-bases. Using sales data as the denominator, a comparison of NSAIDs in the WHO drug monitoring data-base indicates that the reaction is specific to tiaprofenic acid and cannot be accounted for by changes in reporting patterns in certain countries or years. Delayed recognition is an important feature of this reaction and possible reasons for this are discussed. Comparison of the risk profiles of seven NSAIDs indicated that tiaprofenic acid had the poorest risk profile, compared with NSAIDs of similar efficacy, when cystitis reports were included. The results suggest that combining spontaneous reports, classified according to severity, with sales data may enhance the ability of drug monitoring data-bases to contribute to risk benefit appraisals.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1991

[Adverse effects of ulcer drugs before and after release of cimetidine, ranitidine and sucralfate for over-the-counter sale].

During the period from the first marketing of cimetidine in 1977 and until 31 March 1990, the Danish Committee on Adverse Drug Reactions received 494 reports concerning a total of 612 suspected adverse reactions to peptic ulcer drugs (ATC group A02B). Out of these, adverse reactions to H2-receptor antagonists constituted 90%. The investigation confirms the fact that safe drugs are concerned which only rarely cause serious adverse reactions. During the first year after cimetidine, ranitidine and sucralfate became available over-the-counter (27 March 1989-31 March 1990), only one report about side effects caused by cimetidine sold over-the-counter was received. This corresponds to what might be anticipated from the usage figures, if availability over-the-counter does not result in particular adverse reaction problems. Decrease in the number of reports, alterations in the pattern of adverse reactions and under-reporting of known adverse reactions render employment of data from voluntary reports difficult.

Anti-Ulcer Agents↗
PubMed1991

The effect of imipramine and lithium on "learned helplessness" and acetylcholinesterase in rat brain.

The effect of short- and long-term treatment with imipramine and lithium on shock stress-induced escape failures in a shuttlebox (the "learned helplessness" model of depression) was investigated in rats. Acetylcholinesterase (AChE) activity was measured in the frontal cortex, hippocampus and striatum after the shuttlebox test. Imipramine was found to normalize escape behavior, whereas lithium further aggravated escape behavior. No correlation was found between escape behavior and AChE activity in the three brain areas investigated. However, a significant decrease in AChE activity in striatum was found in rats exposed either to shock stress and no drug treatment or to drug treatment and no shock stress. In rats exposed to the combination of shock stress and drug (imipramine or lithium), a slight or no decrease of AChE activity occurred. Exposure to shock stress alone produced no changes in AChE activity in the hippocampus and frontal cortex. In conclusion, lithium did not have an antidepressant effect on "learned helplessness" and AChE activity was not correlated to escape behavior. However, both imipramine and lithium normalized the decreased level of AChE activity in striatum in rats exposed to shock stress.

Acetylcholinesterase↗
PubMed1991

Adverse reactions to H2-receptor antagonists in Denmark before and after transfer of cimetidine and ranitidine to over-the-counter status.

The H2-receptor antagonists cimetidine and ranitidine were transferred from prescription only to over-the-counter (OTC) status in Denmark on March 27, 1989. Reports to the Danish Committee on Adverse Drug Reactions, a voluntary reporting system, have been evaluated to detect possible changes in frequency and pattern of adverse drug reactions (ADRs) caused by the altered delivery status. From the introduction of cimetidine in 1977 and until March 31, 1990, the Committee received 494 reports of 612 suspected adverse reactions to anti-ulcer drugs. The H2-receptor antagonists (mainly cimetidine and ranitidine) were responsible for 548 (90%) of the ADRs. The study, which presents experience with these drugs from more than a decade and a total consumption corresponding to 65 million treatment days, confirms their excellent safety record. Serious reactions were rare, and when they occurred, reversible. During the first year with cimetidine and ranitidine available OTC no changes were seen in reporting frequency or ADR pattern which could be ascribed to OTC transfer. Only one ADR report concerning OTC cimetidine was received. This may be caused by several factors: the safety of these drugs, the fact that only very little was actually sold OTC, and a relatively low sensitivity of the voluntary reporting system.

Adverse Drug Reaction Reporting Systems↗
PubMed1988

Combined boric acid and cinchocaine chloride poisoning in a 12-month-old infant: evaluation of haemodialysis.

A mixture containing 3 g of boric acid and 300 mg of cinchocaine chloride prescribed due to painful dental protrusion was accidentally ingested by a 12-month-old girl. She developed violent vomiting and coughing. Irritability, tremor, seizures and a delirious reaction. She was treated with diazepam, intubated, sedated and ventilated. Her diuresis was stimulated with furosemide and fluid. Within the first 24 h she was treated with haemodialysis twice on femoral catheters. Her renal function was unaffected. In two days she fully recovered. The maximum measured levels of boric acid and cinchocaine chloride approximately 6 h after ingestion were 26 micrograms/ml and 71 ng/ml respectively. The plasma half-life of boric acid was 7.0 h and decreased to 3.6 and 4.4 h during the two haemodialyses. The total body clearance of boric acid increased correspondingly from 21 ml/min to 41 and 34 ml/min. The in vitro clearance of boric acid of the dialyser was later determined to be 18 ml/min. It is concluded that haemodialysis is valuable in the treatment of boric acid intoxication because it increases the elimination of the drug even in patients without any sign of renal toxicity.

Boric Acids↗
PubMed1984

Human pharmacokinetics and safety of boric acid.

Using an in vitro technique it has been demonstrated that water-emulsifying and hydrophobic ointments containing boric acid liberate only minute amounts (1-6%) within 24 h compared with the nearly total liberation from a jelly. When an amount of boric acid containing ointment is swallowed, the absorption is only slightly delayed compared with a similar intake when dissolved in water, and in both cases nearly total excretion is found in the urine within 96 h. The halflife (t 1/2 beta) is 21 h (mean, 7 adult men). The pharmacokinetics rule out the risk of cumulative poisoning with topical preparations containing low amounts of boric acid. The use of water-emulsifying ointments containing up to 3% boric acid should be safe, even for repeated daily use in the napkin region.

Boric Acids↗
PubMed1984

Boric acid single dose pharmacokinetics after intravenous administration to man.

Eight young adult male volunteers with a basic (alimentary) plasma boric acid concentration of less than 0.10 - 0.46 mg/l were given a single dose of boric acid (562-611 mg) by 20 min IV infusion. The plasma concentration curves, followed for 3 days, best fitted a three-compartment open model, although two subjects had to be left out due to inconstant basal plasma concentration values or failure to fit to the three-compartment model. The 120 h urinary excretion was 98.7 +/- 9.1% of dose, Cltot 54.6 +/- 8.0 ml/min/1.73 m2, t1/2 beta 21.0 +/- 4.9 h and distribution volumes V1, V2, and V3: 0.251 +/- 0.099, 0.456 +/- 0.067 and 0.340 +/- 0.128 l/kg.

Adult↗
PubMed1984

Gastro-intestinal absorption and in vitro release of boric acid from water-emulsifying ointments.

Boric acid taken orally by six male volunteers in a cross-over study was absorbed to equal extents from a water solution and a 3% waterless, water-emulsifying ointment, though with a slight initial delay in the latter case. Virtually complete gastro-intestinal absorption and renal excretion were indicated by the 96-hr urinary recovery, amounting to 89.1-98.3% (mean 93.9%) and 89.2-97.5% (mean 92.4%) of the dose ingested as solution and ointment, respectively, normal daily boron excretion having been taken into account. The in vitro release of boric acid, measured for 24 hr by dialysis in water at 37 degrees C, reached 95% from a purely water-based jelly but only about 5% from the water-emulsifying ointment. The low boric acid release from the ointment was not significantly influenced when the ointment was dialysed against buffer solutions of pH 2.5 and 9.6 instead of water, or when the maximum possible amount of water (26.9% w/w) was incorporated into the ointment before dialysis. The 24-hr boric acid release from a number of other oil-based ointments, either hydrophobic or water-emulsifying and containing 1-3% boric acid and 0-28.5% water, was also low (0.9-18.3% of the boric acid content). This indicates that the formulation of the ointment is an important factor in determining the extent of release of boric acid when the ointment is applied externally, but that it does not alter the absorption of boric acid should the ointment be ingested.

Administration, Oral↗