Pub Date : 2024-02-01DOI: 10.1097/fad.0000000000000072
Gerard Ronda-Roca, A. Sancho-López, Belén Ruiz-Antorán, Esther Montero-Hernández, Alicia San Martin-Espinosa
Gentamicin, an aminoglycoside antibiotic, exerts its bactericidal effect primarily through the inhibition of ribosomes in Gram-negative bacteria. It has a concentration-dependent pharmacodynamic effect, making an extended-interval dosage preferable. The total dose is, therefore, usually administered as a single daily dose instead of divided portions two or three times a day. This dosage has shown an excellent efficacy because an appropriate peak concentration is obtained, whilst the risk of nephrotoxicity is reduced as this is correlated with the residual concentration of gentamicin. In the European Medicines Agencies Summary of Products Characteristics, it is stated that deterioration of kidney function could be expected in 1/10 to 1/100 patients treated with gentamicin. We present a 92-year-old female patient with a weight of 39 kg, history of chronic kidney disease (CKD) and chronic heart failure that presented a fatal nephrotoxicity due to a prescription error of gentamicin.
{"title":"A fatal outcome due to a continuous dosage of gentamicin: a case report","authors":"Gerard Ronda-Roca, A. Sancho-López, Belén Ruiz-Antorán, Esther Montero-Hernández, Alicia San Martin-Espinosa","doi":"10.1097/fad.0000000000000072","DOIUrl":"https://doi.org/10.1097/fad.0000000000000072","url":null,"abstract":"\u0000 \u0000 Gentamicin, an aminoglycoside antibiotic, exerts its bactericidal effect primarily through the inhibition of ribosomes in Gram-negative bacteria. It has a concentration-dependent pharmacodynamic effect, making an extended-interval dosage preferable. The total dose is, therefore, usually administered as a single daily dose instead of divided portions two or three times a day. This dosage has shown an excellent efficacy because an appropriate peak concentration is obtained, whilst the risk of nephrotoxicity is reduced as this is correlated with the residual concentration of gentamicin. In the European Medicines Agencies Summary of Products Characteristics, it is stated that deterioration of kidney function could be expected in 1/10 to 1/100 patients treated with gentamicin. We present a 92-year-old female patient with a weight of 39 kg, history of chronic kidney disease (CKD) and chronic heart failure that presented a fatal nephrotoxicity due to a prescription error of gentamicin.\u0000","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139812290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-01DOI: 10.1097/fad.0000000000000072
Gerard Ronda-Roca, A. Sancho-López, Belén Ruiz-Antorán, Esther Montero-Hernández, Alicia San Martin-Espinosa
Gentamicin, an aminoglycoside antibiotic, exerts its bactericidal effect primarily through the inhibition of ribosomes in Gram-negative bacteria. It has a concentration-dependent pharmacodynamic effect, making an extended-interval dosage preferable. The total dose is, therefore, usually administered as a single daily dose instead of divided portions two or three times a day. This dosage has shown an excellent efficacy because an appropriate peak concentration is obtained, whilst the risk of nephrotoxicity is reduced as this is correlated with the residual concentration of gentamicin. In the European Medicines Agencies Summary of Products Characteristics, it is stated that deterioration of kidney function could be expected in 1/10 to 1/100 patients treated with gentamicin. We present a 92-year-old female patient with a weight of 39 kg, history of chronic kidney disease (CKD) and chronic heart failure that presented a fatal nephrotoxicity due to a prescription error of gentamicin.
{"title":"A fatal outcome due to a continuous dosage of gentamicin: a case report","authors":"Gerard Ronda-Roca, A. Sancho-López, Belén Ruiz-Antorán, Esther Montero-Hernández, Alicia San Martin-Espinosa","doi":"10.1097/fad.0000000000000072","DOIUrl":"https://doi.org/10.1097/fad.0000000000000072","url":null,"abstract":"\u0000 \u0000 Gentamicin, an aminoglycoside antibiotic, exerts its bactericidal effect primarily through the inhibition of ribosomes in Gram-negative bacteria. It has a concentration-dependent pharmacodynamic effect, making an extended-interval dosage preferable. The total dose is, therefore, usually administered as a single daily dose instead of divided portions two or three times a day. This dosage has shown an excellent efficacy because an appropriate peak concentration is obtained, whilst the risk of nephrotoxicity is reduced as this is correlated with the residual concentration of gentamicin. In the European Medicines Agencies Summary of Products Characteristics, it is stated that deterioration of kidney function could be expected in 1/10 to 1/100 patients treated with gentamicin. We present a 92-year-old female patient with a weight of 39 kg, history of chronic kidney disease (CKD) and chronic heart failure that presented a fatal nephrotoxicity due to a prescription error of gentamicin.\u0000","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"7 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139872214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01DOI: 10.1097/01.fad.0000997896.20819.3a
{"title":"Subject and Drug Indexes to Adverse Drug Reaction Bulletin: Nos 338–343 February 2023 – December 2023","authors":"","doi":"10.1097/01.fad.0000997896.20819.3a","DOIUrl":"https://doi.org/10.1097/01.fad.0000997896.20819.3a","url":null,"abstract":"","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"357 13","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138625770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-01DOI: 10.1097/FAD.0000000000000071
I. M. Heerfordt, Iben Rix, Henrik Horwitz
Summary This article examines five cases where unintended adverse reactions have led to new therapeutic outcomes. The cases cover subsequent applications of acetylsalicylic acid, sildenafil, thalidomide, domperidone, and disulfiram. These examples demonstrate the versatility of drugs in addressing diverse medical challenges. The discussion highlights the importance of analyzing adverse drug reactions to identify therapeutic opportunities arising from adverse reactions.
{"title":"Therapeutic outcomes arising from adverse drug reactions","authors":"I. M. Heerfordt, Iben Rix, Henrik Horwitz","doi":"10.1097/FAD.0000000000000071","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000071","url":null,"abstract":"Summary This article examines five cases where unintended adverse reactions have led to new therapeutic outcomes. The cases cover subsequent applications of acetylsalicylic acid, sildenafil, thalidomide, domperidone, and disulfiram. These examples demonstrate the versatility of drugs in addressing diverse medical challenges. The discussion highlights the importance of analyzing adverse drug reactions to identify therapeutic opportunities arising from adverse reactions.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"41 2‐3","pages":"1331 - 1334"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138621861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-01DOI: 10.1097/fad.0000000000000070
Philip A. Routledge
Summary In the last 175 years, pharmacovigilance has evolved, albeit sometimes in response to serious incidents. The late Professor Sir Michael D Rawlins made major contributions to pharmacovigilance internationally. He proposed a widely used classification of adverse drug reactions (ADRs). He highlighted the importance of post-marketing surveillance immediately after a medicine's launch, and the strengths and weaknesses of existing spontaneous suspected ADR reporting systems. He encouraged the broadening of pharmacovigilance to involve all health professional groups, as well as patients. He highlighted the value of all sources of evidence and of judgement in making risk-benefit assessments. He was a strong early advocate of greater use of databases and registries, and of continuing surveillance throughout the lifespan of medicines as therapeutic agents.
{"title":"The evolution of pharmacovigilance: the contributions of Michael D Rawlins","authors":"Philip A. Routledge","doi":"10.1097/fad.0000000000000070","DOIUrl":"https://doi.org/10.1097/fad.0000000000000070","url":null,"abstract":"Summary In the last 175 years, pharmacovigilance has evolved, albeit sometimes in response to serious incidents. The late Professor Sir Michael D Rawlins made major contributions to pharmacovigilance internationally. He proposed a widely used classification of adverse drug reactions (ADRs). He highlighted the importance of post-marketing surveillance immediately after a medicine's launch, and the strengths and weaknesses of existing spontaneous suspected ADR reporting systems. He encouraged the broadening of pharmacovigilance to involve all health professional groups, as well as patients. He highlighted the value of all sources of evidence and of judgement in making risk-benefit assessments. He was a strong early advocate of greater use of databases and registries, and of continuing surveillance throughout the lifespan of medicines as therapeutic agents.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136094326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/fad.0000000000000069
Patrick L. Thøgersen, D. Gotfredsen, Christina Gade, Henrik Horwitz, J. T. Andersen
Pharmacologically induced lactation has the potential to help parents of all sexes who wish to breastfeed their children without a preceding pregnancy, and the interest in this possibility is increasing. A combination of hormones, physical stimulation and domperidone to mimic the hormonal changes of pregnancy and birth can be used to induce lactation. However, off-label uses of estrogen, progestin and domperidone or metoclopramide in high doses and for a long period of time have been associated with adverse drug reactions. Before prescribing drugs for induced lactation, it is important to discuss and help manage the parent's expectations regarding the outcome and, in detail, discuss the potential risks.
{"title":"Safety of pharmacologically induced lactation","authors":"Patrick L. Thøgersen, D. Gotfredsen, Christina Gade, Henrik Horwitz, J. T. Andersen","doi":"10.1097/fad.0000000000000069","DOIUrl":"https://doi.org/10.1097/fad.0000000000000069","url":null,"abstract":"\u0000 \u0000 Pharmacologically induced lactation has the potential to help parents of all sexes who wish to breastfeed their children without a preceding pregnancy, and the interest in this possibility is increasing. A combination of hormones, physical stimulation and domperidone to mimic the hormonal changes of pregnancy and birth can be used to induce lactation. However, off-label uses of estrogen, progestin and domperidone or metoclopramide in high doses and for a long period of time have been associated with adverse drug reactions. Before prescribing drugs for induced lactation, it is important to discuss and help manage the parent's expectations regarding the outcome and, in detail, discuss the potential risks.\u0000","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41341728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-06-01DOI: 10.1097/FAD.0000000000000068
Nanna Reiter, C. Andersen, K. Thomsen, C. Wamberg, T. Petersen, K. Dalhoff
Summary The use of chlordiazepoxide in the treatment of alcohol withdrawal symptoms poses a risk of prolonged sedation with the need of weeks lasting antidote treatment, and extended hospitalization due to active metabolites with very long half-lives. We present four case stories to elucidate this issue. One patient received 800 mg chlordiazepoxide and was treated with flumazenil for 42 days. Another patient was treated with 100 mg chlordiazepoxide. 5 days after administration of chlordiazepoxide, concentrations of chlordiazepoxide and its active metabolite demoxepam, were within therapeutic range, the patient was treated with flumazenil for 6 days. He died after palliative care. The great individual variation in the clinical effect of chlordiazepoxide depends on the activity of the CYP P450 system, especially CYP3A4/A5 and CYPS2C19, which can be impaired in cirrhotic and elderly patients.
{"title":"Risk of prolonged sedation with the use of chlordiazepoxide in alcohol withdrawal treatment","authors":"Nanna Reiter, C. Andersen, K. Thomsen, C. Wamberg, T. Petersen, K. Dalhoff","doi":"10.1097/FAD.0000000000000068","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000068","url":null,"abstract":"Summary The use of chlordiazepoxide in the treatment of alcohol withdrawal symptoms poses a risk of prolonged sedation with the need of weeks lasting antidote treatment, and extended hospitalization due to active metabolites with very long half-lives. We present four case stories to elucidate this issue. One patient received 800 mg chlordiazepoxide and was treated with flumazenil for 42 days. Another patient was treated with 100 mg chlordiazepoxide. 5 days after administration of chlordiazepoxide, concentrations of chlordiazepoxide and its active metabolite demoxepam, were within therapeutic range, the patient was treated with flumazenil for 6 days. He died after palliative care. The great individual variation in the clinical effect of chlordiazepoxide depends on the activity of the CYP P450 system, especially CYP3A4/A5 and CYPS2C19, which can be impaired in cirrhotic and elderly patients.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"340 1","pages":"1319 - 1322"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44317592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-04-01DOI: 10.1097/FAD.0000000000000067
Christoffer S. Baden, J. T. Andersen, M. Christensen, Christina Gade
Summary As obesity continues to be a global health challenge presenting various negative impacts on health outcomes and healthcare costs, there is a growing need for pharmacological interventions to address the issue. Glucagon-like peptide-1 receptor agonists have shown potential in treating obesity and reducing the risk of type 2 diabetes, but there is a lack of studies comparing adverse events across different populations. This review intends to indirectly compare the adverse events of available glucagon-like peptide-1 receptor agonist pharmaceuticals for treating overweight or obesity in adults, adolescents, and children.
{"title":"Safety of glucagon-like peptide-1 receptor agonists for weight management in adults, adolescents, and children with obesity: a scoping review","authors":"Christoffer S. Baden, J. T. Andersen, M. Christensen, Christina Gade","doi":"10.1097/FAD.0000000000000067","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000067","url":null,"abstract":"Summary As obesity continues to be a global health challenge presenting various negative impacts on health outcomes and healthcare costs, there is a growing need for pharmacological interventions to address the issue. Glucagon-like peptide-1 receptor agonists have shown potential in treating obesity and reducing the risk of type 2 diabetes, but there is a lack of studies comparing adverse events across different populations. This review intends to indirectly compare the adverse events of available glucagon-like peptide-1 receptor agonist pharmaceuticals for treating overweight or obesity in adults, adolescents, and children.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"339 1","pages":"1315 - 1318"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48207702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-02-01DOI: 10.1097/FAD.0000000000000066
A. Hedengran, M. Kolko
Summary Eye drops are a major cornerstone in the treatment of ophthalmic diseases, and adherence is crucial. Most eye drops are preserved with the surfactant benzalkonium chloride (BAK). Great controversy revolves around the use of BAK, as BAK has continuously been proven to be cytotoxic. In cell cultures, BAK-preserved eye drops cause increased cell death, and in patients, preservation with BAK causes more side effects and ocular surface damage. Side effects can negatively affect adherence and, with this, disease control. This is namely a problem in glaucoma patients. Glaucoma is irreversible, and a lack of disease control may lead to incurable blindness. The purposes of treating ophthalmic diseases are to secure good visual acuity, ocular comfort, and good quality of life for the patients. When administering, BAK-preserved eye drops ocular damage may be inflicted and these purposes are put at risk. Preservative-free and alternatively preserved eye drops are available, why there is no need for the use of BAK.
{"title":"Controversial preservation of eye drops: the toxicity of benzalkonium chloride","authors":"A. Hedengran, M. Kolko","doi":"10.1097/FAD.0000000000000066","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000066","url":null,"abstract":"Summary Eye drops are a major cornerstone in the treatment of ophthalmic diseases, and adherence is crucial. Most eye drops are preserved with the surfactant benzalkonium chloride (BAK). Great controversy revolves around the use of BAK, as BAK has continuously been proven to be cytotoxic. In cell cultures, BAK-preserved eye drops cause increased cell death, and in patients, preservation with BAK causes more side effects and ocular surface damage. Side effects can negatively affect adherence and, with this, disease control. This is namely a problem in glaucoma patients. Glaucoma is irreversible, and a lack of disease control may lead to incurable blindness. The purposes of treating ophthalmic diseases are to secure good visual acuity, ocular comfort, and good quality of life for the patients. When administering, BAK-preserved eye drops ocular damage may be inflicted and these purposes are put at risk. Preservative-free and alternatively preserved eye drops are available, why there is no need for the use of BAK.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"338 1","pages":"1311 - 1314"},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61684716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01DOI: 10.1097/FAD.0000000000000065
S. Mathiesen, Adam Jorgensen
Summary Preschool children may require acute pain and fever management beyond the effects of paracetamol. Ibuprofen, an NSAID, is the first-choice analgesic add-on in children, as its effects and safety profile are well-known in children. In some countries, however, ibuprofen in oral solution is not available; thus, naproxen (another NSAID) could be an alternative. In this systematic review, we evaluated the effect of naproxen on fever and acute pain as well as related adverse events in preschool children. Although the evidence was limited, naproxen appears to be well tolerated and efficient in treating acute pain and fever in preschool children.
{"title":"Safety and efficacy of naproxen for fever and acute pain in preschool children: a systematic review","authors":"S. Mathiesen, Adam Jorgensen","doi":"10.1097/FAD.0000000000000065","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000065","url":null,"abstract":"Summary Preschool children may require acute pain and fever management beyond the effects of paracetamol. Ibuprofen, an NSAID, is the first-choice analgesic add-on in children, as its effects and safety profile are well-known in children. In some countries, however, ibuprofen in oral solution is not available; thus, naproxen (another NSAID) could be an alternative. In this systematic review, we evaluated the effect of naproxen on fever and acute pain as well as related adverse events in preschool children. Although the evidence was limited, naproxen appears to be well tolerated and efficient in treating acute pain and fever in preschool children.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"337 1","pages":"1307 - 1310"},"PeriodicalIF":0.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45297697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}