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Official websites use. Share sensitive information only on official, secure websites. This work is published and licensed by Dove Medical Press Limited. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4. The aim of this study was to analyze data on gabapentinoid-related attendances to the National Poison Control Center of Serbia NPCC , particularly abuse cases; to estimate its changes and to compare it with trends in national consumption rates of these drugs. We also aimed to analyze the main characteristics of the study population and to investigate the major clinical effects in poisoned patients. This is a retrospective study of patients admitted to the NPCC for acute poisoning involving gabapentinoids from 1 May to 1 October There were Abuse of pregabalin was detected in A steady increase in rates of pregabalin poisoning and abuse cases strongly correlated with the increase in overall consumption of this drug, while there were no significant changes in rates of gabapentin consumption, poisoning and abuse rate during the study period. Most patients who abused pregabalin pregabalin were males Co-ingestions occurred in The most often co-ingested drugs were benzodiazepines and among them clonazepam was detected in the largest number of cases. The poisoning and abuse cases involving pregabalin are on the rise in Serbia, which coincided with an increase in its overall consumption during the study period. Isolated pregabalin ingestions resulted in mild poisoning, although severe symptoms such as coma and bradycardia were recorded. When prescribing pregabalin to patients at risk of abuse caution is needed. Strengthening the measures for dispensing of pregabalin may reduce the risks associated with its abuse. Keywords: gabapentinoids, overdose, misuse, drug consumption, psychoactive substances. Drug abuse is a serious health problem worldwide, and acute poisoning remains a significant cause of death. Gabapentinoids pregabalin and gabapentin are a group of drugs that have not traditionally been abused. However, as their therapeutic use has increased, so have the number of reports describing an increase in abuse and overdose with these drugs. We looked at the toxicity levels of these drugs and assessed whether, and to what extent the phenomenon of gabapentinoid abuse is present in Serbia. We found that pregabalin is used much more frequently in therapy in our country compared to gabapentin. The number of patients who abused pregabalin and were treated in NPCC has increased significantly over the past decade. During the same period, therapeutic use and the number of poisoning and abuse cases related to gabapentin were significantly lower and even decreased. When patients took pregabalin alone, it did not cause severe poisoning. However, this drug is mainly used or abused together with other psychoactive substances, which carries a higher risk of developing more serious clinical effects. Pregabalin and gabapentin are psychoactive agents that belong to the drug group gabapentinoids. In some countries pregabalin is approved for the treatment of fibromyalgia syndrome. At the same time, there has been a remarkably smaller change in the use of gabapentin. Currently, there are no official data on gabapentinoid poisonings in Serbia and little is known about the patterns of abuse in our country. The aim of this study is to present data on gabapentinoid related attendances to the National Poison Control Center in Serbia NPCC; a reference institution in our country for the treatment of patients with acute poisoning , particularly abuse cases, estimate their changes and compare them with changes in consumption rates of these drugs in Serbia. We also aimed to describe the main characteristics and clinical manifestations of the study population, in order to improve the current knowledge about gabapentinoid toxicity. This is a retrospective study of patients admitted to the NPCC for acute poisoning involving pregabalin or gabapentin during the year period May 1, October 1, There are approximately patients with acute poisoning treated at the NPCC every year. Data collected on admission and during the hospitalization demographic data, anamnestic and hetero-anamnestic data, laboratory findings, clinical effects, complications, treatment and outcome are archived in the medical record for each patient. Following patient discharge all data are entered into the toxicology database of NPCC, after prior review and assessment of the poisoning severity by a clinical toxicologist. In the available literature an overlap in definitions and various explanations for drug misuse- and abuse-related events could be found. For this study, we decided to use the classification adopted in the Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks ACTTION group review, which suggested following definitions: Abuse - any intentional, nontherapeutic use of a drug, even on a one-time basis, to achieve a desired psychological or physiological effect; Misuse - any intentional therapeutic use of a drug product in an inappropriate manner; Suicide-related event - self-injurious or potentially self-injurious behavior associated with at least some intent to die or that resulted in death. A suicide attempt may or may not result in actual injury. The Poisoning Severity Score PSS , a system that grades the severity of poisoning based on the overall clinical course, regardless of the ingested dose, concentration, type and number of agents involved, was used. The information on ingested dose was self-reported and collected from anamnestic or hetero-anamnestic data. Data related to acute poisonings and abuse cases are presented as absolute numbers or a number of cases per , inhabitants. For this type of study, a formal informed consent was not required by the Ethics Committee. Data were analyzed without identifying patients and confidentiality was maintained throughout the study. The distribution of continuous data was tested with the Kolmogorov—Smirnov and the Shapiro—Wilk test. Since most of the dataset were with non-normal distribution, continuous variables were expressed as medians and interquartile values Q1 The difference between groups was compared with the Mann—Whitney U -test, and the relationship between data was tested with the Spearman correlation coefficient. Categorical variables were expressed as absolute numbers or frequencies of specific categories and the Chi-Square test was used for the analysis. During the study period, there were cases of gabapentinoid-related acute poisoning in patients admitted to NPCC, with 51 repeat readmissions median: 1 readmission; range: 1—5 readmissions. Most cases involved pregabalin The proportion of patients who abused pregabalin and gabapentin was The age distribution was significantly different in the group of patients who abused pregabalin median: 26 years, range: 15—45 years compared to the misuse median: 42 years, range: 13—87 years and suicide-related events group median: 41 years, range: 16—84 years. In all groups, concurrent use of other psychoactive substances was more common than isolated pregabalin poisoning, and benzodiazepines were the most common coingestants. The main route of administration was ingestion and only one patient took pregabalin intranasally. Where the reasons were reported, most of the patients abused pregabalin and gabapentin to achieve a psychoactive effect or to potentiate effects of other co-ingested substances, while in two cases drugs were taken to increase arousal and sexual desire. Examining the average maintenance daily dose Defined Daily Dose: DDD for gabapentinoids in the period between and , there was a steady increase in pregabalin consumption in Serbia from 0. In the same period, the rate of acute poisonings involving pregabalin increased from 0. The first case of pregabalin abuse was detected in it was the only one in that year and the highest number of abuse-related poisonings 30 cases was detected in Gabapentin consumption in Serbia decreased slightly over the year period from 0. During the study period, the maximum number of poisoning cases related to gabapentin was recorded in and four cases in each year. Abuse was detected in three cases in , and in only one case in There were no significant changes nor correlation between the consumption of gabapentin and the rates of acute poisonings or abuse cases. Pregabalin consumption and poisoning cases in National Poison Control Center of Serbia for ten-year period — Due to disproportion and evident higher frequency of pregabalin in acute poisonings and abuse-related cases, data concerning only this drug will be presented in further analysis. To distinguish the main sociodemographic differences and patterns of pregabalin use among the patients in this study, we classified the cases into the following groups: suicide-related events, misuse- and abuse-related cases as presented in Table 1. Suicide-related events accounted for Pregabalin abuse was detected in Most patients who abused pregabalin were male The age distribution in all groups is presented in Figure 2. For categorical data statistical difference between the groups was determined with Chi-Square test. Abbreviations : n, number; Q 1 — Q 3 , Q 1 The dose of pregabalin was recorded in A history of problematic substance use was present in almost half of the patients in all poisoning cases Table 1. In all groups, concurrent use of other psychoactive substances was more frequent than isolated pregabalin poisoning. Benzodiazepines were the commonest coingestants, although there were differences among the groups in frequencies of specific benzodiazepine drugs. The most notable difference was observed for clonazepam. Following benzodiazepines, alcohol and opioids were the most frequently co-ingested substances in the group of patients who abused pregabalin. Illicit drugs eg heroin, cannabis, amphetamines and cocaine were detected in a small number of cases. For a detailed description of the psychoactive substances most commonly co-ingested with pregabalin, see Supplementary Table 1 Parts 1 and 2. Sociodemographic data showed that a large number of patients belonged to the migrant population 55 patients and among them, In this subgroup of the study population, concomitant use of pregabalin and clonazepam was extremely common and detected in The main clinical features of patients admitted to the NPCC due to acute poisoning involving pregabalin are listed in Table 2. The majority of all patients were discharged after the treatment in emergency department Seizures were recorded in only two patients. One of them had a history of epilepsy, while in the other patient the seizure occurred on the eighteenth day of hospitalization, followed by a fatal outcome. Only one patient age 31 years with no history of cardiovascular disease presented with sinus bradycardia, after ingesting only mg of pregabalin. The patient was taking prescribed pregabalin for some time, but on the day of admission he took a higher dose than recommended. After treatment and observation in the emergency department, the patient recovered and was referred to a cardiologist. Notes : For continuous data statistical difference between the groups was determined with the Mann—Whitney U -test. Significantly higher pregabalin plasma concentrations were found in patients hospitalized in the clinic for further treatment and in cases required intubation and mechanical ventilation Supplementary Table 2. The highest pregabalin plasma concentration in this study was found in a female patient age 45 years admitted 3 hours after ingestion of an unknown dose of pregabalin. In this case, pregabalin plasma concentrations were Intubation was performed for airway protection and short-term mechanical ventilation was required because of respiratory failure. Six days after admission, the patient made a full recovery and was discharged from the NPCC clinic. A significant positive correlation was found between the concentration, reported dose, severity of poisoning and length of hospitalization Supplementary Table 2. The dose was recorded in only one patient within the PSS 2 group, that was admitted to the clinic in a coma, after ingesting mg of pregabalin. After the treatment with only supportive therapy, the patient recovered and was discharged after 20 hours of hospitalization. Concentration was measured in only seven cases with isolated pregabalin poisoning so there was no sufficient data for correlation analysis. The most significant finding of this study was the detection of an immense increase in pregabalin poisoning and abuse cases in Serbia. In addition, abuse was detected to a much greater extent in the poisoning cases related to pregabalin compared with gabapentin. The strong correlation between the increase in pregabalin poisonings and overall consumption rates in Serbia since the first year in our observation period , are similar to findings from an Australian study, which showed a fold increase in pregabalin misuse-related events in the period between and , which was strongly associated with an increase in the national prescription rate of this drug. Interestingly, in a report from France, most of the patients who abused pregabalin were adolescents living in migrant shelters. In the same report, half of the patients who co-ingested other drugs were found to be using clonazepam. The association between antiepileptic drug use and increased suicide risk remains conflicting. However, we did not have enough data to analyze this phenomenon in more detail. Our results confirmed previous findings that younger men are a vulnerable group for pregabalin abuse. However, some patients that abused pregabalin reported acquiring the drug on the black market, which is consistent with data from the current literature and confirms that this phenomenon also occurs in our country. Oral ingestion is the main route of administration, although other routes are possible if pregabalin is abused intravenous injection, intranasal snorting, rectal administration etc. This can be explained by the fact that pregabalin concentration in NPCC is determined only at the request of the clinician, when it is considered clinically relevant. Performing the analysis with this protocol risks underestimating the frequency of pregabalin in acute poisonings. In general, pregabalin did not cause severe toxicity in isolated poisoning cases in our study. Coma was recorded in The product summary indicates sinus bradycardia as a possible rare side effect and there are some published reports of adverse cardiac effects associated with pregabalin use and overdose cases. In one case, a young patient with no history of cardiovascular diseases, presented with sinus bradycardia, after ingesting mg of pregabalin only. Although the possibility of seizures occurring in poisoning with pregabalin has been reported in the literature, we could not associate them with pregabalin use in two patients from our study. Concomitant ingestion of other psychoactive substances occurred more frequently and resulted in more severe poisoning. In these cases, we found a positive correlation between ingested dose and pregabalin plasma concentration with PSS score and length of hospital stay. Significantly higher doses of pregabalin were found in patients with coma, bradycardia, and hypotension and in patients who developed pneumonia during hospitalization. Higher doses were also involved in cases requiring more aggressive treatment such as administration of vasopressors, intubation, and mechanical ventilation Supplementary Table 2. At first glance this could imply pregabalin has a dose-dependent additive effect, however more rigorous methodological approach is needed to make this claim. Determination of pregabalin concentration is useful in making a diagnosis when the cause of poisoning is not known or the amount of the ingested drug cannot be reported. Higher pregabalin plasma concentrations were found in patients with more severe poisoning Supplementary Table 2. Clinicians treating acutely poisoned patients should consider pregabalin concentration in the context of the time elapsed between ingestion and hospitalization, and the relatively short half-life of this drug. Together with the relatively small number of patients with analytical confirmation of pregabalin, this may be the reason why we found a better correlation of dose than concentration with the severity of poisoning. In cases of large ingestion and extremely high plasma concentrations of pregabalin, extracorporeal methods of drug elimination might be considered because of its pharmacokinetic properties. Most of the study patients were treated only with symptomatic measures and the administration of intravenous fluids. In , the Food and Drug Administration FDA released a warning on gabapentinoids use and the risk of respiratory depression, especially when combined with other CNS depressants or in patients with impaired lung function. Despite the fact that the abuse potential of gabapentinoids is well recognized to date, there are still differences between countries when it comes to the legal status of these drugs. Pregabalin is classified as a Schedule V controlled substance ie substances with the lowest potential for abuse at the federal level in the United States, whereas there is debate about whether gabapentin should have the same status. The authors stated that this change may help to reduce the risk of abuse. Based on the results of our study and the previous findings from literature, the authorities in Serbia should consider strengthening the regulatory measures for the prescription and dispensing of pregabalin, especially for the population at high risk for drug abuse. The strength of this study is the use and comparison of two data sources, yet there are some limitations. The most important is the retrospective design, which has the potential for inaccuracies in data reporting and bias in risk assessment. For the purpose of this study, all study cases were additionally reviewed by two experienced toxicologists. For most of the cases we could not identify the source of drugs or indication when the drug was prescribed, since this data were not collected systematically in medical records. The information on ingested dose was self-reported. Finally, there is a possibility that the rates of pregabalin poisoning and abuse in Serbia are underestimated for several reasons. As mentioned earlier, analytical confirmation of poisoning cases was done in a third of all study cases, and analysis was performed when deemed necessary by the clinician. In addition, not all poisonings in Serbia are treated in NPCC, however it is a reference facility for acute poisonings and our data may reflect the frequency of poisonings and drug abuse in our country. The results of our study show that the cases of poisoning and abuse of pregabalin are on the rise in Serbia. This coincided with a steady increase in overall pregabalin consumption during the study period. Although there is no evidence of widespread use, abuse and overdose of gabapentin in our country, caution and constant monitoring will be critical in the future. Isolated ingestions of pregabalin lead to minor poisonings, but in most cases other psychoactive substances were co-ingested, resulting in more severe clinical manifestations in the poisoned patients. Clinicians and policy makers should be aware of the risk, and caution should be exercised when prescribing pregabalin to patients at risk of abuse such as socially disadvantaged populations and patients with a history of problematic substance use. Due to the growing toxicological significance of gabapentinoids, analytical laboratories should consider including them in toxicological screening protocols when feasible. In addition to treating acute poisonings as the main task, the National Poison Control Centre in Belgrade will continue to conduct toxicovigilance, in order to prevent and reduce the possible risk for the community and to undertake appropriate and timely measures. Since data on the proportion of gabapentinoids in drug-related deaths are still not available for Serbia, future studies should be conducted to obtain a comprehensive picture of the gabapentinoid abuse in our country. Finally, this study did not aim to diminish the importance and role of gabapentinoids in clinical practice, but to raise awareness of potential risks associated with the growing trend of use of these drugs. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis, and interpretation, or in all areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agree on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. As a library, NLM provides access to scientific literature. Int J Gen Med. Find articles by Marko Antunovic. Find articles by Slavica Vucinic. Find articles by Jelena Kotur-Stevuljevic. Find articles by Kristijan Krstic. Find articles by Jasmina Jovic-Stosic. Find articles by Vesna Kilibarda. Find articles by Natasa Perkovic-Vukcevic. Find articles by Snezana Djordjevic. Received Jan 21; Accepted Apr 3; Collection date Open in a new tab. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Most often co-ingested groups of psychoactive substances n. Benzodiazepines 84 Benzodiazepines Benzodiazepines 70
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