Do classic psychedelics increase the risk of seizures? A scoping review.

Seizures are a concerning adverse event frequently associated with the use of psychedelics, and hence, studies involving these substances tend to exclude patients with past history of epilepsy. This is especially relevant because epileptic seizures are markedly increased in the population suffering from mental disorders, and psychedelic assisted therapy is being researched as a promising treatment for several of them. To determine the extent of the current literature on the relationship between classic psychedelics and seizures, a scoping review was performed using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). The search was conducted in PubMed, Web of Science, Google scholar, LILACS and Scielo, and both animal and human models were included. A total of 16 publications on humans, and 11 on animals, were found. The results are heterogeneous, but globally suggest that psychedelics may not increase the risk of seizures in healthy individuals or animals in the absence of other drugs. However, concomitant use of other substances or drugs, such as kambo or lithium, could increase the risk of seizures. Additionally, these conclusions are drawn from data lacking sufficient external validity, so they should be interpreted with caution. Future paths for research and a summary on possible neurobiological underpinnings that might clarify the relationship between classical psychedelics and seizures are also provided.

Post-marketing surveillance of quetiapine fumarate extended-release tablets in patients with bipolar depression.

AIM: This study aimed to verify the real-world efficacy and safety of quetiapine fumarate extended-release tablets (Bipresso® 50 mg and 150 mg; marketing authorization holder is KYOWA Pharmaceutical Industry Co., Ltd., Osaka, Japan) in patients with bipolar depression. METHODS: We performed a post-marketing surveillance with an observation period of 12 weeks. RESULTS: In the safety analysis group (n = 345), adverse drug reactions (ADRs) occurred in 111 patients (32.17%). The most common ADRs (>1%) were somnolence in 55 patients (15.94%), akathisia in 11 (3.19%), dizziness in 10 (2.90%), weight increase in 6 (1.74%), thirst in 5 (1.45%), and hypersomnia, constipation, and nausea in 4 patients each (1.16%). The only severe ADR was one patient of suicidal ideation, and "longer time since the onset of the first episode" (p = 0.011) and "presence of complications" (p < 0.001) were identified as significant risk factors for the occurrence of ADRs. In the efficacy analysis group (n = 265), the average changes from baseline in the total Montgomery-Åsberg Depression Rating Scale (MADRS) score were -7.3 ± 8.8, -12.2 ± 10.7, -16.8 ± 12.7, and -13.2 ± 12.7 points after 4, 8, and 12 weeks, and at the last evaluation, respectively. The mean MADRS total score decrease had no significant association with maximum daily dose, diagnosis, and presence or absence of prior or concomitant treatment for bipolar disorder with mood stabilizers/antipsychotics/antidepressants. CONCLUSION: The efficacy of quetiapine fumarate extended-release tablets was confirmed in clinical practice, and no new safety concerns or risks were identified.

Ofatumumab Desensitization Protocol: A Case of Refractory Immune Thrombocytopenic Purpura.

Chronic immune thrombocytopenic purpura (ITP) is an acquired hematologic condition that involves immune-mediated platelet destruction with resultant bleeding of variable severity. Refractory ITP occurs when patients fail to tolerate and/or respond to multiple treatment modalities. In this case, we examine the clinical course of a 39-year-old female with refractory ITP and discuss how we navigated a multitude of challenges by adapting an established desensitization protocol to meet our patient's needs. To our knowledge, we describe the first successful desensitization to ofatumumab for use in ITP in the current literature.

Pharmacovigilance Study of Anticancer Drugs in a Tertiary Care Teaching Hospital in North India: A Retrospective Study.

INTRODUCTION: Anticancer agents are responsible for a majority of adverse drug reactions (ADRs) in cancer patients. ADR reporting with anticancer drugs is very rare in India due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India. Hence, this study was done to assess the pattern of ADRs with anticancer agents in cancer patients and to increase awareness about ADR monitoring among healthcare professionals. MATERIALS AND METHODS: This is an observational, retrospective and non-interventional study conducted in an ADR monitoring centre (AMC) in Govt. Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, North India. Voluntarily reported ADR forms with anticancer drugs as suspected drugs over a period of seven years from January 2016 to December 2022 were analyzed. Various parameters were analyzed, which include demographic details of the patients, type of ADR, department reporting ADR and suspected drug. Causality assessment, severity assessment and preventability assessment were done according to the World Health Organization Uppsala Monitoring Centre (WHO-UMC) scale, modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. RESULTS: The maximum numbers of ADRs were reported in the age group of 41-60 years (68.29%) and in females (59.75%). The maximum number of ADRs was reported with the use of taxanes (docetaxel and paclitaxel) (24.39%), targeted drugs (geftinib, imatinib, bortezomib, bevacizumab, rituximab and pazopanib) (24.39%) and platinum co-ordination complexes (cisplatin, oxaliplatin and carboplatin) (17.07%). Majority of the ADRs reported were shivering and ADRs on the skin. Majority of the ADRs were probable (64.70%), mild in nature (85.29%), definitely preventable (45.58%) and probably preventable (45.58%). CONCLUSION: ADR monitoring is needed to increase the outcome of anticancer drug treatment in cancer patients. The quality of treatment in cancer patients can be improved through the timely management of these ADRs. It is a need of the present era to inform healthcare professionals about the Pharmacovigilance Programme to increase the reporting of ADRs due to anticancer drugs.

An updated safety review of the current drugs for managing ADHD in children.

INTRODUCTION: Attention-Deficit/Hyperactivity Disorder (ADHD) is a highly prevalent condition that causes persistent problems with attention and/or hyperactivity-impulsivity and often results in significant impairment when left untreated. Medications for this disorder continue to evolve and provide new treatment options. Ongoing review of related medication safety and tolerability remains an important task for prescribers. AREAS COVERED: This manuscript provides an updated safety review of medications used to treat ADHD in children and adolescents. PubMed and OneSearch online databases were utilized to search for literature relevant to the topic of ADHD medications and safety. Clinical trials of medications used to treat ADHD, systematic reviews and meta-analyses, and articles covering specific safety issues (adverse or unfavorable events) such as cardiovascular effects, seizures, impact on growth, depression, suicidal ideation, substance use disorders, psychosis, and tics are described. EXPERT OPINION: Available pharmacologic treatments for ADHD have favorable efficacy, safety and tolerability and allow many patients to achieve significant improvement of their symptoms. Despite the availability of multiple stimulant and non-stimulant formulations, some individuals with ADHD may not tolerate available medications or attain satisfactory improvement. To satisfy unmet clinical needs, ADHD pharmaceutical research with stimulant and nonstimulant formulations targeting dopamine, norepinephrine, and novel receptors is ongoing.

Adverse Events of Latent Tuberculosis Treatment With Isoniazid in People Living With HIV: A Case-Control Study in a Resource-Rich Setting.

Introduction Multiple risk factors, such as human immunodeficiency virus (HIV) infection and immunosuppressive therapies, increase the odds of latent tuberculosis infection (LTBI) reactivation and progression to active tuberculosis. A six-to-nine-month preventive treatment with isoniazid (INH) decreases the risk of LTBI reactivation, but its effectiveness can be limited by its long duration and adverse events (AEs), including liver toxicity. Due to comorbidities and polypharmacy, people living with HIV (PLHIV) may be at increased risk of INH-associated AEs. Our study aimed to assess the prevalence of AEs among patients receiving INH treatment for LTBI, to identify risk factors for their occurrence, and to evaluate whether PLHIV have higher odds of developing INH-associated AEs. Methods We conducted a single-center retrospective case-control study, including 130 outpatients with LTBI treated with INH between July 2019 and March 2022. Participants who developed AE (cases) were compared to controls, and a subgroup of PLHIV was compared to HIV-negative participants. Demographics, socioeconomic variables, comorbidities, and clinical variables were compared between study groups. Patient data were obtained from institutional electronic medical records, and outcomes were measured at regularly scheduled appointments. Results We included 130 participants, of which 54 were PLHIV. The PLHIV subgroup was significantly younger (p = 0.01) and demonstrated significantly higher prevalences of chronic liver disease, previous viral hepatitis, daily alcohol consumption, and intravenous drug use (IDU). One-third of the participants had an AE (45 cases, 34.6%), with liver toxicity being the most common (22.3%). Participants who developed AEs were significantly older (p = 0.030) and had a higher prevalence of economic hardship (p = 0.037), as well as higher scores of the Charlson comorbidity index (p = 0.002) than the controls. INH withdrawal occurred in 17 participants (13.1%) and was mainly associated with liver toxicity (p < 0.01) and gastrointestinal symptoms (p = 0.022). In the adjusted effect model, an age ≥ 65 years, economic hardship, and excessive alcohol consumption were significantly associated with higher odds of AEs, while HIV infection decreased the odds by 68.4% (p = 0.033). Conclusions In our study, INH-associated AEs were common, with liver toxicity being the most frequent. Older age, economic hardship, and excessive alcohol consumption increased the odds of INH-associated AEs, while PLHIV had lower odds of developing INH-associated AEs, even when adjusting for other variables in the multivariate analysis. Further studies should be conducted to assess if these results are replicable in a larger population and in different settings.

Tuberculosis infection following immune checkpoint inhibitor treatment for advanced cancer: a case report and literature review.

Objective: To investigate the clinical features of active tuberculosis (TB) infection due to immune checkpoint inhibitors (ICIs) treatment in patients with advanced cancer. Methods: We report the diagnosis and treatment of a case of pulmonary malignancy (squamous cell carcinoma, cT4N3M0 IIIC), secondary to active TB infection following ICIs therapy. Moreover, we summarize and analyze other related cases collected from the China National Knowledge Infrastructure (CNKI), Wanfang Database, PubMed, the Web of Science, and EMBASE (up to October 2021). Results: A total of 23 patients, including 20 males and 3 females who were aged 49-87 years with a median age of 65 years, were included in the study. Twenty-two patients were diagnosed by Mycobacterium tuberculosis culture or DNA polymerase chain reaction (PCR), while the remaining patient was diagnosed by tuberculin purified protein derivative and pleural biopsy. One case had an interferon-gamma release assay (IGRA) to rule out latent TB infection prior to the application of ICI. Fifteen patients received an anti-tuberculosis regimen. Among the 20 patients with a description of clinical regression, 13 improved and 7 died. Seven of the patients who improved were treated with ICI again and four of them did not experience a recurrence or worsening of TB. The case diagnosed in our hospital also improved after receiving anti-TB treatment after stopping ICI therapy, and continued chemotherapy on the basis of anti-TB treatment, and his condition is relatively stable at present. Conclusion: Due to the lack of specificity of TB infection following ICIs therapy, patients should be followed for fever and respiratory symptoms for 6.3 months after drug administration. It is recommended that IGRA should be performed before ICIs therapy and the development of TB during immunotherapy in patients who are positive in IGRA should be closely monitored. The symptoms of TB in most patients can be improved with ICIs withdrawal and anti-TB treatment, but there is still a need to be alert to the potentially fatal risk of TB.

Use of the Electronic Health Record for Monitoring Adverse Drug Reactions.

PURPOSE OF REVIEW: Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality. The electronic health record (EHR) provides an opportunity to monitor ADRs, mainly through the utilization of drug allergy data and pharmacogenomics. This review article explores the current use of the EHR for ADR monitoring and highlights areas that require improvement. RECENT FINDINGS: Recent research has identified several issues with using EHR for ADR monitoring. These include the lack of standardization between EHR systems, specificity in data entry options, incomplete and inaccurate documentation, and alert fatigue. These issues can limit the effectiveness of ADR monitoring and compromise patient safety. The EHR has great potential for monitoring ADR but needs significant updates to improve patient safety and optimize care. Future research should concentrate on developing standardized documentation and clinical decision support systems within EHRs. Healthcare professionals should also be educated on the significance of accurate and complete ADR monitoring.

TFOS Lifestyle: Impact of elective medications and procedures on the ocular surface.

The word "elective" refers to medications and procedures undertaken by choice or with a lower grade of prioritization. Patients usually use elective medications or undergo elective procedures to treat pathologic conditions or for cosmetic enhancement, impacting their lifestyle positively and, thus, improving their quality of life. However, those interventions can affect the homeostasis of the tear film and ocular surface. Consequently, they generate signs and symptoms that could impair the patient's quality of life. This report describes the impact of elective topical and systemic medications and procedures on the ocular surface and the underlying mechanisms. Moreover, elective procedures performed for ocular diseases, cosmetic enhancement, and non-ophthalmic interventions, such as radiotherapy and bariatric surgery, are discussed. The report also evaluates significant anatomical and biological consequences of non-urgent interventions to the ocular surface, such as neuropathic and neurotrophic keratopathies. Besides that, it provides an overview of the prophylaxis and management of pathological conditions resulting from the studied interventions and suggests areas for future research. The report also contains a systematic review investigating the quality of life among people who have undergone small incision lenticule extraction (SMILE). Overall, SMILE refractive surgery seems to cause more vision disturbances than LASIK in the first month post-surgery, but less dry eye symptoms in long-term follow up.

Inclusion of Potentially Inappropriate Medicines for the Older Adults in the Brazilian Consensus in Accordance with International Criteria.

AIM: The use of potentially inappropriate medications (PIM) can impair the safety and effectiveness of pharmacotherapy in the older adults. Thus, several countries have lists and criteria to indicate these drugs, in order to promote the safety of prescription and the rational use of drugs in geriatric practice. OBJECTIVE: This study sought to contribute to the inclusion of PIM for the older adults in the Brazilian criterion (BCPIM/2016) - current list used in Brazil and reference in Latin American countries - through expert approval, comparing convergences with international AGS lists BEERS/2019, STOPP/START/2015, PRISCUS/2010 and EU (7)-PIM List/2015. METHODS: This is a critical analysis of potentially inappropriate medications for use in the older adults present in the list of Brazilian criteria, together with their absence of some drugs that are on international lists (BEERS/2019; Priscus/2010; Stopp/Start/2015; EU7-PIM list/2015). This study was subdivided in 6 stages: selection of national criteria, classification of drugs according to Anatomic Therapeutic Chemical, comparison between BCPIM/2016 with international lists, selection of drugs not included in the Brazilian list, selection of experts for evaluation and suggestions about drugs not included in the Brazilian list and the synthesis of the analysis carried out by the specialists. RESULTS: We cataloged 66 drugs marketed in Brazil that are on international lists, but not in the Brazilian consensus, of which 24 were validated by experts as necessary for inclusion in this consensus, considering the risks and benefits in health care for the older adults. However, the lists have divergences and similarities between them. We observed that eight drugs were common to all criteria studied, mainly related to the nervous system. CONCLUSION: The results suggest the need for periodic validation of PIM against research clinics, new drugs and the inclusion of this agenda by the Ministry of Health in the revision of the National List of Essential Drugs and other Clinical Protocols and Therapeutic Prescription Guidelines for the older adults.

BNT162b2 Vaccine-Associated Myo/Pericarditis in Adolescents: A Stratified Risk-Benefit Analysis.

BACKGROUND: Male patients ages 12-17 years have an elevated risk of mRNA vaccination-associated myo/pericarditis. A risk-benefit analysis of first and second doses of mRNA vaccination in adolescent boys by health status and history of SARS-CoV-2 infection has not been performed. METHODS: Using the Vaccine Adverse Event Reporting System (VAERS), we identified BNT162b2 [Pfizer-BioNTech] myo/pericarditis occurrence according to CDC criteria. Main outcomes were as follows: 1) post-vaccination myo/pericarditis crude incidence in adolescents aged 12-15 and 16-17; and 2) two risk-benefit analyses by age, sex, comorbidity, variant and history of infection. RESULTS: Cases of myo/pericarditis (n = 253) included 129 after dose 1 and 124 after dose 2; 86.9% were hospitalized. Incidence per million after dose two in male patients aged 12-15 and 16-17 was 162.2 and 93.0, respectively. Weighing post-vaccination myo/pericarditis against COVID-19 hospitalization during delta, our risk-benefit analysis suggests that among 12-17-year-olds, two-dose vaccination was uniformly favourable only in nonimmune girls with a comorbidity. In boys with prior infection and no comorbidities, even one dose carried more risk than benefit according to international estimates. In the setting of omicron, one dose may be protective in nonimmune children, but dose two does not appear to confer additional benefit at a population level. CONCLUSIONS: Our findings strongly support individualized paediatric COVID-19 vaccination strategies which weigh protection against severe disease vs. risks of vaccine-associated myo/pericarditis. Research is needed into the nature and implications of this adverse effect as well as immunization strategies which reduce harms in this overall low-risk cohort.

Vascular complications caused by hyaluronic acid injection: a clinical analysis / 中华医学美学美容杂志

Objective:To analyze the epidemiological characteristics of vascular complications induced by hyaluronic acid facial injection.Methods:Patients with vascular complication induced by facial hyaluronic acid facial injection were collected in the Fourth Medical Center of the General Hospital of the Chinese People's Liberation Army from January 1, 2016 to October 1, 2021, including 5 males and 37 females. The age ranged from 16 to 70 (34±10) years. The clinical data, injection site, clinical symptoms and previous facial surgery history of the patients were analyzed and investigated.Results:Vascular complications occurred in 12 cases (28.6%). Nasolabial fold in 8 (19.0%) cases; Glabella in 6 (14.3%) cases; frontal part in 6 (14.3%) cases. There were 27 patients (64.3%) with a history of facial surgery. Furthermore, history of facial surgery had no effect on the clinical manifestations of vascular complications ( P>0.05). Among the 18 patients with visual impairment, 12 patients reported that the symptoms of ptosis, bulbar conjunctival congestion, and eye movement dysfunction had diminished after thrombolytic treatment, while 4 patients showed recovery to some extent in visual acuity. Likewise, 24 patients with blood circulation disorders were healed after treatment, with residual pigmentation and a slight scar left. Conclusions:Women aged 30 to 39 years old are the main target population of cosmetic surgery, as well as the most common population of vascular complications. Particular care should be taken in the nose, nasolabial fold, glabella and forehead areas of the operation. Patients with previous surgical history should be adequately informed before surgery, and postoperative observation time should be appropriately prolonged.

Analysis of Influencing Factors and Pharmaceutical Care of Patients with COVID-19 in Fangcang Shelter Hospital.

PURPOSE: In December 2019, coronavirus disease 2019 (COVID-19) was first identified in Wuhan, and rapidly spread throughout China. Patients with mild symptoms were admitted to Fangcang shelter hospitals for centralized quarantine. We aimed to clarify the medication usage, related adverse reactions, and pharmaceutical interventions in patients with mild COVID-19. PATIENTS AND METHODS: We innovatively carried out targeted pharmacy services. We provided online and off-line pharmaceutical services to patients in the Fangcang shelter hospital. The use of medication, related adverse reactions, and the effects of pharmaceutical intervention were analyzed. RESULTS: Lower blood lymphocyte count was proposed as the most significant risk factor in patients with mild illness. All patients received antiviral treatment (arbidol, oseltamivir, and ribavirin); 78.4% of patients received antibiotic therapy (moxifloxacin, levofloxacin, and cefdinir); patients in the moderate disease group received more antibiotic therapy than those in the mild disease group. Most of the patients were treated with traditional Chinese medicine. Patients with moderate disease preferred to receive sedative hypnotic therapy. Diarrhea, nausea and vomiting, insomnia, arrhythmia, and constipation were the most common adverse reactions. The rate of mild-to-moderate illness in the pharmaceutical intervention and non-intervention groups was 20.6% and 31.7%, respectively. CONCLUSION: Most patients with mild illness were treated with antiviral, antibiotic, and Chinese medicine therapy. However, attention should be paid to patients with mild illness presenting with hypertension and low lymphocyte count at the onset; these patients are more likely to develop moderate or severe disease. Moreover, there were many drug-related problems in Fangcang shelter hospital; pharmaceutical care might contribute to alleviate the progress of the patient's condition. Pharmacists should be prepared to provide skilled and effective services to patients, with the aim to ensure medication safety and promote the overall control of the COVID-19 pandemic.

Analysis of Adverse Drug Reactions with Carbamazepine and Oxcarbazepine at a Tertiary Care Hospital.

PURPOSE: To describe adverse drug reactions (ADRs) to carbamazepine (CBZ) and oxcarbazepine (OXC), including severe cutaneous ADRs, at a tertiary care hospital over a 10-year period. MATERIALS AND METHODS: The frequency and clinical features of ADRs caused by CBZ and OXC were analyzed using the pharmacovigilance database and spontaneous ADR reporting data of Yonsei University Severance Hospital & Dental Hospital (Seoul, Korea) from January 1, 2010 to January 31, 2020. RESULTS: Among 10419 cases prescribed CBZ and OXC, 204 ADR cases were reported. The incidences of ADRs were 1.8% and 2.2% for CBZ and OXC respectively, with no significant difference (p=0.169). The most common clinical presentations were skin disorders. Female patients had relatively more frequent ADRs than male patients. Although mild skin ADRs were more frequent with OXC, nervous system disorders, general disorders, and hepatobiliary disorders occurred more often with CBZ. There were six reports of severe cutaneous adverse reactions to CBZ, while OXC had none. Both CBZ and OXC caused ADRs at daily doses lower than the recommended initial dose. CONCLUSION: Due to lower incidence of severe ADRs with OXC than CBZ, we suggest OXC as a first-line prescription.

Bevacizumab in Combination with TAS-102 Improves Clinical Outcomes in Patients with Refractory Metastatic Colorectal Cancer: A Retrospective Study.

OBJECTIVE: TAS-102 is effective for treating patients with metastatic colorectal cancer (mCRC). This study determined whether combining bevacizumab (Bmab) with TAS-102 improves clinical outcomes in refractory mCRC. PATIENTS AND METHODS: We retrospectively analyzed data from Japanese patients with refractory mCRC who received TAS-102 (35 mg/m2 , twice a day) with (T-B group) or without Bmab (TAS-102 monotherapy; T group) between July 2014 and December 2018. The primary endpoint was median overall survival (OS), and secondary endpoints were median time to treatment failure, overall response rate, and the incidence of adverse events. Clinical outcomes were compared using propensity score matched analysis. RESULTS: Data from 57 patients were analyzed (T-B group: 21 patients, T group: 36 patients). Median OS was significantly longer in the T-B group than the T group (14.4 months vs. 4.5 months, p < .001). Cox proportional hazard analysis showed that combination therapy with Bmab was significantly correlated with OS. Propensity score matched analysis confirmed that the median OS was significantly longer in the T-B group than the T group (14.4 months vs. 6.1 months, p = .006) and that there was a significant correlation between Bmab and OS. The incidence of hypertension (grade ≥2) as an adverse event was significantly higher in the T-B group than the T group (23.8% vs. 0.0%, p = .005), whereas other adverse events were comparable between the two groups. CONCLUSION: Treatment with Bmab in combination with TAS-102 is significantly associated with improved clinical outcomes in patients with mCRC refractory to standard therapies. IMPLICATIONS FOR PRACTICE: Combining bevacizumab (Bmab) with TAS-102 significantly improved overall survival and several prognostic indicators in patients with metastatic colorectal cancer (mCRC) refractory to standard therapies, with manageable toxicities. Treatment with Bmab in combination with TAS-102 is significantly associated with improved clinical outcomes in patients with mCRC.

Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial.

BACKGROUND: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). METHODS: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. RESULTS: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was 34.2 ± 9.9 and 37.9 ± 10.6 years in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. CONCLUSIONS: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.

Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: Results from a Phase III, Multicenter, Open-Label Study and a Phase I Phototoxicity Study.

Objective: We sought to evaluate the safety, tolerability, and patterns of use for the once-daily oral, narrow-spectrum antibiotic sarecycline in patients with moderate-to-severe acne vulgaris during a 40-week Phase III, multicenter, open-label extension study. Participants: Patients aged nine years or older with moderate-to-severe acne who completed one of two prior Phase III, double-blind, placebo-controlled, 12-week trials in which they received sarecycline 1.5mg/kg/day or placebo were included. Measurements: The primary assessment was the safety of sarecycline 1.5mg/kg/day for 40 weeks as indicated by adverse events (AEs), vital signs, electrocardiograms, clinical laboratory tests, and physical examinations. Patterns of sarecycline use were a secondary assessment. Results: The safety population included 483 patients; 354 patients (73.3%) completed the study. The most common reasons for premature discontinuation were withdrawal by the patient (14.5%), lost to follow-up (7.9%), and AEs (2.5%). The most common treatment-emergent AEs (TEAEs) were nasopharyngitis (3.7%), upper-respiratory-tract infection (3.3%), headache (2.9%), and nausea (2.1%). Clinical laboratory evaluations suggested no clinically meaningful differences between the treatment sequences. Rates of TEAEs commonly associated with other tetracycline antibiotics include dizziness (0.4%) and sunburn (0.2%), and for gastrointestinal TEAEs, nausea (2.1%), vomiting (1.9%), and diarrhea (1.0%). Also reported herein are the results of a Phase I phototoxicity study. Conclusion: Patients aged nine years or older with moderate-to-severe acne vulgaris who received sarecycline once daily for up to 40 weeks showed low rates of TEAEs, with nasopharyngitis, upper-respiratory-tract infection, headache, and nausea being the only TEAEs reported by 2% or more of patients. No clinically meaningful safety findings were noted. ClinicalTrials.gov Registration: NCT02413346.

Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial

BACKGROUND: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). METHODS: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. RESULTS: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was 34.2 ± 9.9 and 37.9 ± 10.6 years in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. CONCLUSIONS: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.

Intravenous pulses of methylprednisolone to treat flares of immune-mediated diseases: how much, how long?

Introduction Glucocorticoids are widely used in the treatment of immune-mediated diseases. Despite their widespread use, details on dosing, effectiveness and adverse effects are yet to be determined. Objective To know the current use of methylprednisolone (MTP) in the management of immune-mediated conditions, evaluating the relationship among doses, therapeutic response and adverse effects. Methodology A multicenter retrospective cohort study was designed, including patients who received intravenous pulses of MTP between 1 January 2013 and 12 December 2015 in three different hospitals in Uruguay. The patients included received MTP to treat systemic autoimmune diseases (SADs), hematological, nephrological and neurologic diseases and others. The following variables were analyzed: age, gender, MTP cumulative dose, duration of treatment, clinical response (complete, partial and no response) and adverse effects. Results In total, 164 cases were identified, of which 118 (72%) were female. The median age was 48.4 (SD: 18) years. The indications for MTP included: neuroimmune-mediated 92 (56.1%), SADs 29 (17.5%), hematological 15 (9.1%), nephrological 12 (7.3%) and others 16 (9.9%). The median dose to achieve complete response was 3.2 g (SD: 1.5); the median dose to accomplish a partial response was 3.5 g (SD: 1.25); the median dose for non-responders was 3.3 g (SD 1.2) ( p > 0.05). The median dose in those patients with adverse effects was 3.4 g (SD 1.5) and the median dose for those who did not experience adverse effects was 3.3 g (SD: 1.3) ( p > 0.05). The most frequent adverse effects were infectious (22/164, 13.4%). Diabetics were found to have the highest incidence of adverse effects (13/16, 81%) in comparison to non-diabetics, p < 0.05. Discussion Our study suggests a wide range of doses and duration of treatments with MTP. No major associations were found between clinical response and the use of high MTP doses, but the latter was associated with a large proportion of severe infections. No severe infections were identified with MTP doses lower than 1.5 g. The diabetic population is known to be at risk of experiencing varied adverse effects to MTP. These observations reinforce the need for protocolized use of MTP in order to achieve a better relationship among doses, effectiveness and safety profile.

Reações adversas a medicamentos na cavidade bucal de idosos / Adverse reactions caused by drugs in the oral cavity of the elderly / Reacciones adversas a medicamentos en la cavidad bucal de ancianos

Os indivíduos com idade avançada consomem maior número de medicações e, como consequência, surgem reações adversas frequentes a essas drogas, inclusive na cavidade bucal. O objetivo é verificar as reações adversas na cavidade oral relacionadas aos medicamentos, a fim de que sejam diagnosticadas corretamente e se executem ações que as reduzam ou eliminem. Como metodologia, nesta revisão, foram buscados artigos originais relatando estas reações em idosos, em inglês, português e espanhol, publicados de 2000 a 2018, usando-se termos relevantes ao tema, publicados on-line nas bases de dados dos periódicos da CAPES. Os artigos foram selecionados após leitura dos seus títulos e resumos efetuando-se, a seguir, leitura completa dos mesmos. Os Resultados mostram que, entre os 12 artigos selecionados, tivemos: 6 (50%) sobre xerostomia; 2 (17%) com ulcerações orais consequentes ao nicorandil; 2 (17%) com osteonecrose da mandíbula (bifosfonato e bevacizumab, um em cada); e 1 (8,3%) com ageusia (associada a romidepsin); e 1 (8,3%) com candidíase (associada a corticoide inalatório). Concluiu-se que o idoso requer atenção redobrada durante as consultas médicas e procedimentos odontológicos, em razão da associação de diferentes doenças crônicas e o uso contínuo de diversas medicações. Há necessidade de maior número de publicações focando este tema neste grupo etário, principalmente naqueles indivíduos mais longevos.

Introduction: The individuals with advanced age are the ones who consume the greatest number of medications and, as consequence, adverse reactions to these drugs often occur, including in the oral cavity. Objective: These drug-related manifestations deserve attention of health professionals so that they are properly diagnosed and actions are taken to reduce or eliminate them. Material and methods: In this article, we reviewed original articles, published from 2000 to 2018, reporting these reactions in elderly patients. Articles in English, Portuguese and Spanish were searched, using terms relevant to the topic, published online in the CAPES journals databases. The articles were selected after reading their titles and summaries and, then, the complete articles. Results: Among the 12 articles showing adverse drug reactions in the oral cavity of the elderly, we had: 6 (50%) with xerostomia and its consequences; 2 (17%) with oral ulcerations consequent to the use of nicorandil; 2 (17%) with osteonecrosis of the mandible (bisphosphonate and bevacizumab, one in each); and 1 (8.3%) with ageusia (associated with romidepsin) and 1 (8.3%) with oral candidiasis (associated with inhaled corticosteroids). Conclusion: The elderly require increased attention during medical consultations and dental procedures, due to the association of different chronic diseases and the continuous use of several medications. There is a need for a greater number of publications focusing on this theme in this age group, especially in those longevous senior individuals.

Los individuos con edad avanzada consumen mayor número de medicamentos y, como consecuencia, surgen reacciones adversas frecuentes a estos fármacos, incluso en la cavidad bucal. El objetivo es verificar las reacciones adversas en la cavidad oral relacionadas con los medicamentos, a fin de que sean diagnosticadas correctamente y se ejecuten acciones que las reduzcan o eliminen. La metodología de esta revisión se buscaron artículos originales que informaron estas reacciones en las personas mayores, en inglés, portugués y español, publicados desde 2000 hasta 2018, si el uso de términos relacionados con el tema, publicados en línea en las bases de datos CAPES periódicas. Los artículos fueron seleccionados después de leer sus títulos y resúmenes efectuando, a continuación, lectura completa de los mismos. Los resultados muestran que, entre los 12 artículos seleccionados, tuvimos: 6 (50%) sobre xerostomía; 2 (17%) con ulceraciones orales consecuentes al nicorandil; 2 (17%) con osteonecrosis de la mandíbula (bifosfonato y bevacizumab, uno en cada uno); y 1 (8,3%) con ageusia (asociada a romidepsin); y 1 (8,3%) con candidiasis (asociada a corticoides inhalados). Se concluyó que el anciano requiere atención redoblada durante las consultas médicas y procedimientos odontológicos, en razón de la asociación de diferentes enfermedades crónicas y el uso continuo de diversas medicaciones. Hay necesidad de mayor número de publicaciones enfocando este tema en este grupo de edad, principalmente en aquellos individuos más longevos.