Search Results (8)

Psychotropic drugs (PDs) include anxiolytics, sedatives and hypnotics, antidepressants, and antipsychotics, and they are available as medicines with different safety profiles. Given Portugal’s high anxiolytic consumption and the rising prevalence of mental disorders, safety monitoring is crucial. This study aimed to analyze the individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) related to PDs, obtained through spontaneous reporting, and recorded in the Portuguese National Pharmacovigilance System between January 2017 and December 2021. This observational and retrospective study analyzed the ICSRs of suspected ADRs to PDs. Most reports pertained to female individuals (67.78%) between 18 and 64 years of age (63.71%). The pharmaceutical industry was the primary source of these reports (62.16%). Antidepressants were responsible for most ICSRs (61.90%). At least one serious ADR was recorded in 58.44% of the reports, and 43.84% of ADRs evolved into “cure”. The most-observed ADRs were nausea (10.92%), dizziness (10.70%), and off-label use (10.30%). In the causality assessment, 45.49% of ADRs were classified as “possible”, and only 4.96% were classified as “definitive”. The current analysis helps to strengthen the safety evidence for PDs. In the future, some measures could be implemented to improve the use of and/or access to PDs, as well as to reinforce the rate of suspected ADR reports within the community, contributing to the safety data available. Full article

Falls are not always considered direct adverse drug reactions (ADRs). However, due to their mechanism of action, certain drugs increase the risk of falls. This retrospective study aimed to evaluate the association between drugs and the risk of falls. An analysis of ADR reports submitted to a national pharmacovigilance database from 1992 to 2021 was performed using terms from the MedDRA dictionary. This included the word “fall” and terms related to conditions potentially predisposing patients to falls. The analysis involved examining the sex and age distribution of the population. Reports were assessed for seriousness, the class of the suspected drug, and the characterisation of fall events when they occurred. Over this period, 2217 cases were reported, with the majority occurring among females (60.71%) and the age group of 18–64 years old (38.43%). Most reports were classified as serious across all age groups, and immunomodulators (16.78%) were the most frequently reported pharmacotherapeutic class of suspected drugs. Falls were reported as ADRs in 343 cases, with fractures being the most commonly reported injuries (24.45%). In conclusion, falls can pose a significant health problem. Therefore, continuously monitoring drugs is crucial to minimise fall-associated risk factors. Full article

The first line medication for the treatment of type 2 diabetes is metformin. This study aims to investigate the safety profile of metformin and metformin combination medications in older adults using pharmacovigilance data. A literature search was used to identify published clinical studies reporting safety of metformin in older patients (age ≥ 65 years old), which were then thoroughly evaluated. Additionally, a deep analysis was performed, taking into account suspected adverse drug reaction (ADR) reports submitted to the Portuguese Pharmacovigilance System involving patients with 65 years old or older, with metformin or metformin combination as the suspected drug. The results suggest that metformin is safer when used in combination with other antidiabetics than when used in monotherapy. Metformin prolonged-release tablets have a lower incidence of adverse effects compared to treatment with immediate-release metformin tablets. The analysis of the reports showed that “gastrointestinal disorders” was one of the most common classes reported, and metformin alone was the drug most commonly associated with serious gastrointestinal reactions that resulted in hospitalization. In addition, it was the drug most commonly associated with the lactic acidosis ADR. Even though most ADRs in the reports were serious, the majority progressed to cure. According to the analysis performed, the results suggest that the patient’s renal function should be considered in order to prevent ADRs associated with metformin, such as lactic acidosis. Therefore, monitoring the safety profile of metformin remains essential to prevent serious ADRs. Full article

Criteria have been developed to identify potentially inappropriate medications that can enhance adverse reactions, highly prevalent in older patient’s therapy. This study aimed to identify potentially inappropriate medications within the adverse drug reactions reported in the Portuguese pharmacovigilance system, characterizing the reports where inappropriate medications were identified. INFARMED, I.P. provided all adverse drug reactions reported from January to December 2019 in 65-year-old and older patients. Adverse drug reactions were characterized according to the System Organs Classes, seriousness, and medications with the Anatomical Therapeutical Classification. Potentially inappropriate medications were identified by applying the EU-(7)-PIM and the Beers criteria. A p value < 0.05 was considered statistically significant. From the 2337 reports considered for the analysis, PIMs were found in 12.8% of these, and 64.7% of all adverse reaction reports were classified as serious. Within the group of reports including at least one PIM, 71.4% were classified as serious, with hospitalization the most common criteria (35.1%). From the 3170 suspected medicines identified, 10.6% were classified as PIMs. Amiodarone was the most frequent PIM identified in the study (10.1%). Reports including at least one PIM were more associated with a higher number of ADRs (p = 0.025) reported in the same record, higher number of suspected medicines identified (p < 0.001), seriousness (p = 0.005), and hospitalization (p < 0.001). Potentially inappropriate medications are important enhancers of serious adverse drug reactions, increasing the likelihood of hospitalizations. This reinforces the importance of improving medication appropriateness in the older population. Full article

Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently used agents to treat musculoskeletal disorders (principally by the elderly), thus raising the risk of adverse drug reactions (ADRs). This work aims to monitor NSAIDs safety profile in older people by using literature and pharmacovigilance data. Published clinical studies reporting the NSAIDs safety in elderly patients (age ≥ 65) were identified by a literature search and were then deeply analyzed. In addition, suspected ADRs reports submitted to the Portuguese Pharmacovigilance System (PPS) involving patients aged ≥65 with at least one NSAID as suspected drug were explored in detail. Most studies concluded that the risk of gastrointestinal, cardiovascular, and renal ADRs was significantly lower with cyclooxygenase-2 (COX-2)-selective NSAIDs use than with nonselective NSAIDs. The PPS data analysis showed that serious gastrointestinal ADRs occurred mostly in patients taking more than one NSAID and/or another concomitant drug that increases the incidence of these events, in the absence of gastroprotection. The results suggest that while NSAID toxicity is well understood, their safe use needs to be monitored in clinical practice. Furthermore, the pharmacovigilance data analyzed also showed that monitoring NSAIDs use in elderly remains essential to mitigate the associated risks, especially in those with comorbidities and under polytherapy. Full article

Inhaled medication used for treatment of chronic obstructive lung diseases (asthma, chronic obstructive pulmonary disease-COPD, and Asthma-COPD overlap) may be associated with adverse drug reactions (ADRs). The aim of this study was to characterise spontaneous reports (SRs) of suspected ADRs received by the Portuguese Pharmacovigilance System (PPS), from 2007 to 2017. Methods: Retrospective observational study of SRs associated with single substance and combination inhalers, analysed in terms of pharmacological class of the involved drugs, sex and age range of the involved patients, and seriousness and type of ADRs. Results: 230 SRs were analysed, accounting for a total of 599 suspected ADRs. Inhaled corticosteroid/long-acting beta-2 agonist combination had the highest frequency in SRs (32.2%) and in ADRs (32.7%). There was a slight predominance in men (51.3%) and non-elderly adults were the most affected age group (39.1%). Most SRs were serious (70.4%). In total, “respiratory, thoracic and mediastinal diseases” ADRs were the most reported (19.5%), with “dyspnea” being the most frequent (4.8%). Conclusions: Most SRs were associated with controller medications and were expected. Most ADRs involved non-elderly adults, were serious and of respiratory nature and many were due to overuse of reliever medication. Full article

Background: Drug induced liver injury (DILI) is an adverse drug reaction that causes liver damage in a predictable (dose-dependent) or an unpredictable (idiosyncratic) fashion. We performed an assessment of DILI in Portugal, by analyzing the reports, sent to the Portuguese Pharmacovigilance System (PPS). Methods: A search was performed on the PPS database, in a 10-year time frame, from 1 January 2010 to 31 December 2019. Results: There was not a prevalence of either sex in any age group. Most reports (n = 1120, 55.0%) belonged to patients in the age group 19–64 years old. Hepatitis (n = 626, 26.7%) was the most common adverse drug reaction in our study. Hepatotoxicity (n = 362, 15.5%) and hepatitis (n = 333, 14.2%) were more frequent in age group 19–64 years old. Cholestasis was more prevalent in adults independently of age. Hepatic fibrosis and encephalopathy were more common in the elderly. Most patients consumed between one and four suspected drugs (n = 1867, 92%). Most patients in our study evolved to “cure” (n = 796; 39%). Hepatotoxicity (n = 23; 13.8%) and hepatitis (n = 610; 25.9%) had a female predominancy while choluria (n = 8; 4.8%) and splenomegaly (n = 8; 4.8%) were of male predominance. Conclusions: DILI is rare but can be fatal. As such, an active search of DILI is necessary. Full article

There is a consensus that elderly individuals are quite vulnerable to adverse drug reactions (ADRs), and headaches are one of the most frequent clinical presentations of central nervous system problems in the general population, which can be an ADR. The purpose of our work was to analyze reports of “headache” associated ADRs in the elderly sent to the Portuguese Pharmacovigilance System (PPS), and also which drugs were more frequently associated with this adverse reaction. A retrospective analysis of suspected ADR reports involving patients aged 65 years or older received by the PPS in the last 10 years was conducted. A search of all the terms associated with the High Level Term “headache” was performed. All duplicate reports were excluded from the analysis. A total of 155 ADRs reports were included, in which 15 reported isolated “headache” as suspected ADR, while the remaining 140 ADRs reports reported “headache” together with several other adverse reactions. Most reports of “headache” ADR occurred in women (74.8%; n = 116). About half (46.5%; n = 72) of the ADR reports were considered serious. Anti-viral medication, anti-depressants, anti-dyslipidemic agents and central nervous system-acting analgesics were the most frequent drugs associated with “headache” ADR reports in this population. In elderly patients, most ADR reports involving headaches occurred in women and a high percentage (46.5%) were considered serious. Thus, it is important that healthcare professionals pay more attention to headaches reported as ADRs in the elderly and drugs suspected to cause them, in order to increase knowledge about this type of reaction and contribute towards safely using drugs in this age group. Full article