Loss of Seizure Control Associated with Generic Substitution of Carbamazepine

1992 ◽  
Vol 26 (6) ◽  
pp. 775-777 ◽  
Author(s):  
Timothy E. Welty ◽  
Patricia R. Pickering ◽  
Bradford C. Hale ◽  
Richard Arazi

OBJECTIVE: We report two cases of lost seizure control associated with the generic substitution of carbamazepine, review pertinent literature, and discuss the impact of this substitution on patient care. DATA SOURCES: Case studies, abstracts, and research publications identified in MEDLINE and bibliographic review. DATA EXTRACTION: One author reviewed cases supplied by the other authors and abstracted information from published literature sources. DATA SYNTHESIS: The first case describes a 15-year-old boy who received valproic acid and carbamazepine for partial seizures. A change in government program policies caused him to receive generic carbamazepine. This resulted in loss of seizure control and a decrease in his serum carbamazepine concentration from 12.4 to 6.7 μg/mL. When his carbamazepine concentration returned to previous levels, seizure control was not reestablished. A second case involves a 21-year-old woman who substituted generic carbamazepine because of financial problems. After being seizure-free for at least five years on phenobarbital and carbamazepine, she experienced seizures related to the product change. Her carbamazepine concentration decreased from 11.8 to 8.5 μg/mL; she also became pregnant at that time. Seizure control was not reestablished. At least three other studies do not support these observations, but the tightly controlled conditions in these studies may not have simulated actual clinical practice. CONCLUSIONS: When generic substitution of carbamazepine is required, serum concentrations should be carefully monitored. The extra care required may negate the financial advantages of the substitution.

2005 ◽  
Vol 39 (6) ◽  
pp. 1097-1108 ◽  
Author(s):  
Paul M Beringer ◽  
Richard L Slaughter

OBJECTIVE: To review the recent advances in knowledge about human transporters and their effect on drug disposition. DATA SOURCES: A MEDLINE search (1996–March 2005) was performed to identify pertinent literature on human transporters and their impact on drug disposition. Additional articles were identified from a manual search of the references of retrieved articles. STUDY SELECTION AND DATA EXTRACTION: Based on the identified studies, data were extracted on the impact of transporters on drug absorption, distribution, and elimination. DATA SYNTHESIS: The pharmacokinetic disposition of drugs is known to be influenced by metabolic enzymes, kidney function, and transporters. Recent research on human transporters has greatly advanced our understanding of their diversity and importance in drug disposition. In particular, members of the multidrug resistance family of transporters (MDR, MRP) are present in organs and tissues throughout the body and are known to significantly affect the absorption, distribution, and elimination of commonly prescribed drugs. A growing number of studies now demonstrate that alterations in transporter function as a result of drug interactions or genetic polymorphisms may explain a significant portion of the variability in treatment response for certain drugs. CONCLUSIONS: Human transporters contribute significantly to the pharmacokinetic disposition of drugs. Knowledge of substrates, inducers, and inhibitors of these transporters is necessary to ensure optimal patient outcomes.


1992 ◽  
Vol 26 (9) ◽  
pp. 1089-1090 ◽  
Author(s):  
Margaret Kuo ◽  
Nancy Winiarski ◽  
Serafino Garella

OBJECTIVE: To report the case of a patient who developed nonthrombocytopenic purpura sequentially following the administration of nifedipine and diltiazem. DATA SOURCES: Case reports, MEDLINE review of pertinent literature, and review of relevant studies. DATA EXTRACTION: Data were extracted from direct patient observation and review of laboratory studies and published reports. DATA SYNTHESIS: Nonthrombocytopenic purpura secondary to cutaneous vasculitis is a known, although rare, adverse effect of nifedipine. It has not been reported in association with diltiazem. We report the case of a 75-year-old woman in whom a purpuric rash demonstrated by biopsy to be attributable to cutaneous vasculitis developed in the course of nifedipine therapy. The rash disappeared after discontinuation of the drug; however, it recurred when diltiazem therapy was initiated. CONCLUSIONS: Nonthrombocytopenic purpura may be associated with diltiazem as well as with nifedipine. When this adverse effect occurs following administration of a calcium-channel blocker, caution is advised in using other agents of the same class.


2011 ◽  
Vol 31 (5) ◽  
pp. 767-777 ◽  
Author(s):  
Rachel A. Crockett ◽  
Stephen Sutton ◽  
Fiona M. Walter ◽  
Megan Clinch ◽  
Theresa M. Marteau ◽  
...  

Background. The impact of providing information about medicines to patients on decisions about starting or continuing them is unknown. Purpose. To estimate the impact on decisions to start or continue medicines, of providing information to patients about possible benefits and/or harms. Data Sources. Electronic searches from 1980 to October 2010; reference and citation searches of included studies. Study Selection. Two investigators assessed studies' eligibility against inclusion criteria: randomized or pseudorandomized trials; participants older than 16 years and deciding for themselves; one group received information about possible benefits and/or harms of a potentially beneficial medicine, compared with another who did not; d) a measure of decision about starting or continuing a medicine. Data Extraction. One investigator extracted all data, checked by a second. Data Synthesis. Eight studies were included, covering a range of medicines. There was no consistent impact of interventions on decisions about whether to start or continue medicines (pooled odds ratio 1.08; 95% confidence interval [CI], 0.69–1.70; P = 0.74). Among those who received more information, knowledge was increased (pooled mean difference 8.47; 95% CI 2.17–14.77; P = 0.008), and decisional conflict was reduced (pooled mean difference -0.15; 95% CI -0.24 to -0.06; P = .001). Limitations. A small number of studies across different clinical contexts, of uncertain heterogeneity, were included. Conclusions. Providing information to patients about possible benefits and/or harms has no consistent effect on the number who decide to start or continue medicines, although it increases patients' knowledge and reduces their decisional conflict.


1993 ◽  
Vol 27 (9) ◽  
pp. 1073-1081 ◽  
Author(s):  
Nina M. Graves

OBJECTIVE: To provide an up-to-date review of the current literature on felbamate (FBM) and its use as an antiepileptic medication (AEM). DATA SOURCES: All published literature (manuscripts and abstracts) on FBM was reviewed. The initial bibliography (up to September 1992) was provided by the manufacturer (Carter-Wallace Laboratories); subsequent literature was obtained from American Epilepsy Society presentations in December 1992 and manuscripts published up to January 1993. STUDY SELECTION/DATA EXTRACTION: All pertinent literature was reviewed. Information from the publications was abstracted and organized by the author. DATA SYNTHESIS: FBM is effective in complex partial seizures either as monotherapy or as an adjunct in patients receiving other AEMs. In addition, it has shown efficacy in some seizures associated with the Lennox-Gastaut syndrome. Adverse effects appear to be mild. When FBM is given as monotherapy, the primary adverse effects are insomnia and weight loss. Patients receiving multiple AEMs may have increased adverse effects. CONCLUSIONS: FBM appears to be an effective new AEM. Additional studies as to its role in newly diagnosed and pregnant patients are needed. Pharmacokinetic studies in children, patients with renal failure, and patients on nonepilepsy drugs also are needed.


2021 ◽  
pp. 089011712110393
Author(s):  
Suzi B. Claflin ◽  
Shannon Klekociuk ◽  
Hannah Fair ◽  
Emmanuelle Bostock ◽  
Maree Farrow ◽  
...  

Objective: Systematically review the evaluation and impact of online health education interventions: assess approaches used, summarize main findings, and identify knowledge gaps. Data Source: We searched the following databases: EMBASE, ERIC, MEDLINE, and Web of Science. Study Inclusion and Exclusion Criteria: Studies were included if (a) published in English between 2010-2020 in a peer-reviewed journal (b) reported an online health education intervention aimed at consumers, caregivers, and the public (c) evaluated implementation OR participant outcomes (d) included ≥ 100 participants per study arm. Data Extraction: Two authors extracted data using a standardized form. Data Synthesis: Data synthesis was structured around the primary outcomes of the included studies. Results: 26 studies met the inclusion criteria. We found substantial heterogeneity in study population, design, intervention, and primary outcomes, and significant methodological issues that resulted in moderate to high risk of bias. Overall, interventions that were available to all (e.g., on YouTube) consistently attained a large global reach, and knowledge was consistently improved. However, the impact on other outcomes of interest (e.g., health literacy, health behaviors) remains unclear. Conclusion: Evidence around the impacts of the type of online health education interventions assessed in this review is sparse. A greater understanding of who online interventions work for and what outcomes can be achieved is crucial to determine, and potentially expand, their place in health education.


2020 ◽  
Vol 54 (7) ◽  
pp. 706-714
Author(s):  
Caroline Der-Nigoghossian ◽  
Drayton A. Hammond ◽  
Mahmoud A. Ammar

Objective: To summarize literature evaluating vasopressin use, focusing on clinical controversies regarding initiation, dosing, and discontinuation and interaction of vasopressin with other therapies in septic shock patients. Data Sources: A PubMed English-language literature search (January 2008 to December 2019) was performed using these terms: arginine vasopressin, septic, shock, and sepsis. Citations, including controlled trials, observational studies, review articles, guidelines, and consensus statements, were reviewed. Study Selection and Data Extraction: Relevant clinical data focusing on specific controversial questions regarding the utility of vasopressin in patients with septic shock were narratively summarized. Data Synthesis: Current literature does not strongly support the use of vasopressin as a first-line initial therapy for septic shock. Additionally, there are conflicting data for weight-based dosing of vasopressin in overweight patients. Evidence for vasopressin renal protection and interaction with corticosteroids is minimal. However, vasopressin has the ability to reduce catecholamine requirements in septic shock patients and may provide a mortality benefit in specific subgroups. Discontinuation of vasopressin last, not second to last, in resolving septic shock may reduce hypotension development. Relevance to Patient Care and Clinical Practice: This review addresses specific clinical controversies that drive vasopressin use in septic shock patients in real-world practice. Conclusion: Vasopressin should remain second-line adjunct to norepinephrine to augment mean arterial pressures. Dosing should be initiated at 0.03 U/min, and higher doses offer minimal benefit. There are conflicting data on the impact of weight on vasopressin response. Studies have failed to show renal benefit with vasopressin use or an interaction with corticosteroid therapy.


1993 ◽  
Vol 27 (11) ◽  
pp. 1389-1392 ◽  
Author(s):  
Grace Hayes ◽  
Maria E. Kootsikas

OBJECTIVE: To critically review available data on the effective lower end of the phenytoin therapeutic range for the treatment of seizure disorders. DATA SOURCES: Relevant articles were identified from an English-language search of MEDLINE 1982-1992. Additional references were found in bibliographies of these articles. STUDY SELECTION/DATA EXTRACTION: We reviewed articles that included data on serum phenytoin concentrations (SPCs) and seizure control. Data on concurrent anticonvulsants, seizure diagnosis, and seizure severity were extracted when available. DATA SYNTHESIS: The original study defining the phenytoin therapeutic range as 10–20 mg/L is analyzed; it was based on a small, homogeneous sample that cannot be generalized to a more diverse epileptic population. Many studies report patients obtaining seizure control with SPCs below 10 mg/L. Studies including a range of seizure diagnoses and severity have a larger variability in effective SPCs; however, effective SPCs are reproducible. CONCLUSIONS: The therapeutic range of phenytoin is defined on an individual basis. Some patients, especially those with infrequent, primary tonic-clonic seizures, may be controlled with phenytoin concentrations below the recognized reference range of 10–20 mg/L.


2020 ◽  
Author(s):  
Ahmed Youssef Kada

BACKGROUND Covid-19 is an emerging infectious disease like viral zoonosis caused by new coronavirus SARS CoV 2. On December 31, 2019, Wuhan Municipal Health Commission in Hubei province (China) reported cases of pneumonia, the origin of which is a new coronavirus. Rapidly extendable around the world, the World Health Organization (WHO) declares it pandemic on March 11, 2020. This pandemic reaches Algeria on February 25, 2020, date on which the Algerian minister of health, announced the first case of Covid-19, a foreign citizen. From March 1, a cluster is formed in Blida and becomes the epicentre of the coronavirus epidemic in Algeria, its total quarantine is established on March 24, 2020, it will be smoothly alleviated on April 24. A therapeutic protocol based on hydroxychloroquine and azithromycin was put in place on March 23, for complicated cases, it was extended to all the cases confirmed on April 06. OBJECTIVE This study aimed to demonstrate the effectiveness of hydroxychloroquin/azithromycin protocol in Algeria, in particular after its extension to all patients diagnosed COVID-19 positive on RT-PCR test. We were able to illustrate this fact graphically, but not to prove it statistically because the design of our study, indeed in the 7 days which followed generalization of therapeutic protocol, case fatality rate decrease and doubling time increase, thus confirming the impact of wide and early prescription of hydroxychloroquin/azithromycin protocol. METHODS We have analyzed the data collected from press releases and follow-ups published daily by the Ministry of Health, we have studied the possible correlations of these data with certain events or decisions having a possible impact on their development, such as confinement at home and its reduction, the prescription of hydroxychloroquine/azithromycin combination for serious patients and its extension to all positive COVID subjects. Results are presented in graphics, the data collection was closed on 31/05/2020. RESULTS Covid-19 pandemic spreads from February 25, 2020, when a foreign citizen is tested positive, on March 1 a cluster is formed in the city of Blida where sixteen members of the same family are infected during a wedding party. Wilaya of Blida becomes the epicentre of coronavirus epidemic in Algeria and lockdown measures taken, while the number of national cases diagnosed begins to increases In any event, the association of early containment measures combined with a generalized initial treatment for all positive cases, whatever their degree of severity, will have contributed to a reduction in the fatality rate of COVID 19 and a slowing down of its doubling time. CONCLUSIONS In Algeria, the rapid combination of rigorous containment measure at home and early generalized treatment with hydroxychloroquin have demonstrated their effectiveness in terms of morbidity and mortality, the classic measures of social distancing and hygiene will make it possible to perpetuate these results by reducing viral transmission, the only unknown, the reopening procedure which can only be started after being surrounded by precautions aimed at ensuring the understanding of the population. CLINICALTRIAL Algeria, Covid-19, pandemic, hydroxychloroquin, azithromycin, case fatality rate


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047283
Author(s):  
Rosalind Gittins ◽  
Louise Missen ◽  
Ian Maidment

IntroductionThere is a growing concern about the misuse of over the counter (OTC) and prescription only medication (POM) because of the impact on physical and mental health, drug interactions, overdoses and drug-related deaths. These medicines include opioid analgesics, anxiolytics such as pregabalin and diazepam and antidepressants. This protocol outlines how a systematic review will be undertaken (during June 2021), which aims to examine the literature on the pattern of OTC and POM misuse among adults who are accessing substance misuse treatment services. It will include the types of medication being taken, prevalence and demographic characteristics of people who access treatment services.Methods and analysisAn electronic search will be conducted on the Cochrane, OVID Medline, Pubmed, Scopus and Web of Science databases as well as grey literature. Two independent reviewers will conduct the initial title and abstract screenings, using predetermined criteria for inclusion and exclusion. If selected for inclusion, full-text data extraction will be conducted using a pilot-tested data extraction form. A third reviewer will resolve disagreements if consensus cannot be reached. Quality and risk of bias assessment will be conducted for all included studies. A qualitative synthesis and summary of the data will be provided. If possible, a meta-analysis with heterogeneity calculation will be conducted; otherwise, Synthesis Without Meta-analysis will be undertaken for quantitative data. The reporting of this protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.Ethics and disseminationEthical approval is not required. Findings will be peer reviewed, published and shared verbally, electronically and in print, with interested clinicians and policymakers.PROSPERO registration numberCRD42020135216.


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
H Mistry ◽  
B Woolner ◽  
A John

Abstract Introduction Open abdominal surgery confers potentially greater risk of surgical site infections, and local evidence suggests use of drains can reduce this. Our objectives were: Assessing local rates and risk factors of infections and if use of drains can reduce the rates of infections. Method Retrospectively looking from 01/01/2018 to 31/12/2018, at patients following laparotomy or open cholecystectomy. Data collection on demographics, smoking/alcohol status, heart, respiratory or renal disease or diabetes, steroid use and CEPOD status, as well as use of drain and the outcome of infection using inpatient and online patient records. Results 84 patients included, 25 had drains inserted. There were 13 documented cases of surgical site infection, all of whom had no drain post-op. Other parameters shown to be most prevalent in the patients with a surgical site infection include being current/ex-smoker (8/13), having heart disease (9/13), and elective procedures. Conclusions Aiming to reduce the risk of surgical site infections can improve morbidity and potentially mortality outcomes. Our audit data showed that there appears to be a benefit of inserting intra-abdominal or subcutaneous drains. We will create a standard operating procedure of all patient to receive drains post-op and then re-audit to assess the impact this has on infection rates.


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