Scientific evidence on the pharmacological and toxicological effects of Luffa operculata has been produced on a smaller scale, even though the species: (i) is edible; (ii) widely recognized in folk medicine for treating sinusitis and inducing abortion; (iii) and the basis of allopathic and homeopathic medicines. In this sense, the objective of this review is to characterize the pharmacological, toxicological and clinical profile of products based on L. operculata. After consulting 14 databases, as well as a free search on Google/Google Scholar and checking references, 85 studies were selected that met our eligibility criteria. After analysis and synthesis, we found that the products have a wide range of pharmacological activities in vitro, ex vivo and in vivo. The toxicological spectrum is also alarming in different segments such as: cytogenotoxicity, tissue toxicity, (sub-) acute, reproductive, neuro- and phytotoxicity. The intensity of the pharmacological and toxicological effects is variable, and seems to be conditioned by various factors (examples: plant organ, polarity of the extracting solvent, quantity, experimental model and route of administration). Clinical data show that the products have satisfactory efficacy, tolerability and safety in the treatment of upper airway diseases (especially rhinitis and sinusitis). Finally, we hope that the presentation of toxicological information in this review can guide the safe and rational use of L. operculata in folk medicine. It may also serve as scientific evidence for exploring the pharmacological potential of the species, avoiding its side effects.

Pelargonium sidoides DC. (Geraniaceae) is a widely recognized medicinal plant whose natural extract exhibits therapeutic effects through a multi-target approach. Existing literature encompasses investigations of antimicrobial and cellular effects, including clinical trials. A comprehensive review is required to summary the substantial number of published investigations and to grasp the potentialities of this extract. The aim of this scoping review was to provide an overview of the antimicrobial, antiadhesive, immunomodulatory, and respiratory effects of the P. sidoides extract, along with a discussion of its mechanism of action, clinical safety, potential repurposing uses, and areas requiring further investigation. A systematic search of Medline (PubMED) and Scopus databases was conducted using the terms: EPs7630, Pelargonium, Pelargonium sidoides. The search process was finished on 5th, June 2024. Two researchers screened titles and abstracts according to the eligibility criteria, which included in vitro, in vivo, randomized, and non-randomized clinical trials. Out of 4367 publications identified, 134 studies were included in this review. A structured form was applied for data extraction. PRISMA-ScR was used to guide reporting of this review. Most of the studies were conducted in vitro, followed by human studies and animal models. The findings demonstrated a strong and broad-spectrum antimicrobial and antiadhesive effect against various bacterial, fungi, and virus species. Additionally, a strong immunomodulatory effect was observed, including the induction of pro-inflammatory cytokines during infection, and modulation of other immune response components. The effects on the respiratory system have been extensively examined, showing remarkable clinical efficacy against both bacterial and viral infections with no significant cytotoxicity or adverse effects. Furthermore, recent research showed an anti-COVID effect by direct antiviral and immunomodulation mechanisms. Nonetheless, the establishment of a concentration protocol to further studies is still challenging due to variations in extract origin, composition and extraction methods. In this sense, the use of a commercial extract such as EPs® 7630 is of great value to facilitate the standardization of the tested protocols. The noteworthy anti-infective potential of P. sidoides extract lies in its multifaceted mechanism of action, which encompasses direct microbicidal effects and modulation of the immune response. These unique properties establish P. sidoides extract as a promising alternative in the war against a wide range of infectious diseases.

Background: Medicinal herbs are incorrectly believed to be free of risks and are commonly used for self-medication without medical supervision. Jordan does not currently have a national policy on traditional medicine (TM) and/or complementary/alternative medicine (CAM). The present study aims to explore the use of and beliefs about the efficacy of medicinal plants among the Jordanian population. Method: A cross-sectional study was conducted using a self-administrated questionnaire for the duration between April and June 2019. Multiple linear regression analysis was used to identify predictors of positive attitudes towards the use of medicinal plants. Results: A total of 1,057 individuals participated in the study. The participants in our study showed a positive attitude towards the use of medicinal plants and herbs (median score of 33.0 (interquartile range (IQR): 26.0-37.0; equals 68.8% of the maximum total score), and believed in alternative therapies other than chemical drugs for disease treatment, mainly using medicinal herbs and plants. The majority of the participants (77.8% (n = 822)) believe in the efficacy of the use of medicinal herbs and plants and are aware (64.6 % (n = 683)) of the correct and proper way of using these plants and herbs. Pharmacists and herbalist are the main sources of information for the proper use of medicinal herbs and plants. Age was the main predictor of positive attitudes towards the use of medicinal plants and herbs (P<0.001). Conclusion: Efforts must be made to regulate the dispensing of these products, to educate health service providers and to raise consumer awareness.

According to the World Health Organization (WHO), about 80% of people rely on medicinal plants for their primary health needs. Traditional medicine's principal benefits are their vast population knowledge, low severe adverse effects rate, low cost, and the lack of a medical prescription to use them. While obesity has become a global health issue, an increase in finding cheap and fast ways to lose weight escalates medicinal herbs' use for this purpose, both in dietary supplements or in teas. At the same time that Brazil aims to expand traditional medicine, reports regarding toxicology and poisoning put natural products' safety in check. Plants can accumulate heavy metals and metalloids leading to health risks; however, there is a lack of information on that matter, possibly due to a lack of international standardization regarding elemental contamination - this study aimed to determine metal and metalloid concentrations in slimming medicinal plants and their respective teas and evaluate their safety consumption. Metal and metalloid content were determined by inductively coupled plasma optical emission spectrometry (ICP OES). All plants and teas were within the set limits for tolerable upper intake level (UL), provisional tolerable daily maximum intake (PTDMI), and provisional tolerable weekly intake (PTWI). The hazard quotient index (HQ) was above 1 for almost all plants, and the Hibiscus sabdariffa tea regarding aluminum content. The arsenic level was above the Brazilian Pharmacopeia limit in natura plants demonstrating risk in their consumption. Some herbs also presented detection for elements with no safety limits set, such as lead, cadmium, and arsenic, which could mark as a red flag for consumption once their security intake is not precise yet.

Adverse drug reactions are responsible for increased costs and morbidity in the health system. Hepatotoxicity can be induced both by non-prescription drugs and by those used for chronic diseases. It is the main cause of safety-related drug marketing withdrawals and could be responsible for irreversible and fatal injuries.

To identify and to summarize Brazilian studies reporting the drug-induced liver injury.

A systematic review of Brazilian studies was carried out until June 2020. It was found 32 studies, being 10 retrospective cohorts, 12 prospective cohorts, 5 cross-sectional, 3 case-control, one case series and one randomized clinical trial. In most studies were investigated tuberculosis patients followed by other infectious conditions like human immunodeficiency virus (HIV) and hepatitis C virus. The hepatotoxicity ranged from one to 57%, led by isoniazid, rifampicin, and pyrazinamide. Few studies reported algorithm to assess causality. In most studies, there were moderate outcomes and it was necessary drug interruption. However, few severe outcomes, such as chronic liver damage and liver transplantation were reported.

Twenty-two different criteria for hepatotoxicity were found. The great heterogeneity did not allow a meta-analysis. Standardization of parameter of drug-induced liver injury and greater effort in pharmacovigilance could contribute to learn more about drug-induced liver injury (DILI)'s epidemiology in Brazil.

The development of strategic public health policies seems to have an influence on the DILI scientific evidence in Brazil due to main studies are in HIV and tuberculosis line care, two strategic health policies in Brazil.

Although hepatotoxicity accounts for 10% of adverse drug reactions, it remains poorly understood and underreported. This study aimed to summarize case reports of herb- and drug-induced liver injury in Brazil.

Systematic review in the following databases: PubMed, SciELO, Science Direct, CAPES, and gray literature.

Twenty-seven studies reporting 32 cases were identified. Brazilian cases were primarily detected in hospitals, and occurred mainly in young males suffering from chronic diseases. Drugs (n=29) were a more frequent cause of liver injury than herbs (n=3). Almost a third of these drugs were anticonvulsants, and 15 appear in the Brazilian List of Essential Medicines. In 50% of the cases, clinical manifestations started within 30 days of drug ingestion. Regarding the decline of liver enzymes, 50% of the cases reached normality after drug withdrawal. However, 7 deaths and 2 liver transplantations were reported. Only one study assessed causality using RUCAM.

Given the severe outcomes of DILI and HILI, early detection and management of hepatotoxicity to increase drug safety are necessary, as well as pharmacotherapeutic monitoring of patients with chronic diseases. Moreover, the application of the RUCAM algorithm in clinical practice has to be further disseminated.

During the post-marketing period, when medicines are used by large population contingents and for longer periods, unexpected adverse events (AE) can occur, potentially altering the drug's risk-benefit ratio enough to demand regulatory action. AE are health problems that can occur during treatment with a pharmaceutical product, which in the drug's post-marketing period can require a significant increase in health care and result in unnecessary and often fatal harm to patients. Therefore, a key objective for the health system is to identify AE as soon as possible in the post-marketing period. Some countries have pharmacovigilance systems responsible for collecting voluntary reports of post-marketing AE, but studies have shown that social networks can be used to obtain more and faster reports. The current project's main objective is to build a totally automated system using Twitter as a source to detect both new and previously known AE and conduct the statistical analysis of the resulting data. A system was thus built to collect, process, analyze, and assess tweets in search of AE, comparing them to U.S. Food and Drug Administration (FDA) data and the reference standard. The results allowed detecting new and existing AE related to the drug doxycycline, showing that Twitter can be useful in pharmacovigilance when employed jointly with other data sources.

Self-medication and the belief that herbal products are free of health risks are common in Brazil. The kava (Piper methysticum), known for its anxiolytic action, has a widespread popular use. Hepatotoxicity of kava is reported, including cases of liver transplantation and death. The kava had its use prohibited or restricted in countries like Germany, France, among others. Toxicity may be related to overdosage; however, factors such as botanical characteristics of the plant, the harvesting, storage, and production process may be associated with the development of hepatotoxic substances, such as triggering idiosyncratic reactions.

In this case, there is a suspicion that the toxicide is intrinsic to the drug; however, the possibility of adulterants and contaminants must be ruled out.

This study reports the case of a patient who, after using the herbal kava for 52 days, evolved into acute liver failure and liver transplantation.

The data were collected directly with the patient and compared with their clinical records. Causality was determined through the RUCAM algorithm. In addition, a phytochemical analysis of the drug used was performed.

According to the patient's report, there is no evidence of overdosage. Results from RUCAM algorithm infer causality between liver damage and the use of kava. The analysis chemical constituents did not find any possible contaminants and major changes in the active compounds. Seven months after transplantation, the patient is well and continues to be followed up by a medical team.

Our investigation indicates that there was kava-induced hepatotoxicity at standard dosages. In Brazil, self-medication by herbal medicines is frequent and many patients and health professionals do not know the risks associated with their use. Diagnosing and notifying cases in which plants and herbal medicine induce liver damage is of paramount importance to increase the knowledge about DILI and to prevent or treat similar cases quickly.

This scoping review aims to describe and characterize the Brazilian pharmacovigilance system Brazil (SINAF) and verify to what extent it meets the minimum requirements proposed by the World Health Organization for the functional performance of this type of national system. The literature search strategy used STARLITE recommendations and search terms in MEDLINE/PubMed, Google, the Brazilian National Press, and the website of the Brazilian Health Regulatory Agency (Anvisa), from 1999, when Anvisa was created, to March 2016. The review included 47 publications (4.4%), out of a total of 1,068 identified, in the following order: 14 legal provisions (29.8%), 13 (27.6%) technical documents, and 10 (21.3%) scientific articles. The studies and technical documents covered the creation of the first pharmacovigilance technical unit at the federal level, the reporting system for adverse events, the National Monitoring Center, and the Technical Chambers on Medications. The reporting rate for adverse drug events in Brazil in 2013 was 36 reports per million inhabitants, considerably lower than the target proposed in the international literature, which suggests 300 reports per million inhabitants. This study identified structural and functional aspects that can compromise the performance of SINAF, such as lack of legislation officially establishing the system itself and its objectives.

the herbal medicinal products (HMP) market is expanding in the world, an expansion that has not occurred in Brazil when considering the number of licensed products. Despite being a megadiverse country, the number of HMP licensed in Brazil is small, and the number of HMP obtained from native species is even smaller. A new legislation for herbal products licensing, which divides the products into two categories, Herbal Medicine (HM) and Traditional Herbal Product (THP) was launched in Brazil focusing on traditional use, as well as a law regulating the use of biodiversity and traditional knowledge.

to evaluate the situation of HMP licensed in Brazil and to make a comparison with the data obtained in 2008 and 2011, discussing the evolution of the licensed products and the possible impacts of the new legislation.

a survey was carried out in the Brazilian Health Regulatory Agency (Anvisa) database to verify the HMP licensed in Brazil in September 2016. The data obtained were compared with two surveys previously published.

There are 332 single, and 27 combined HM, totaling 359 HM licensed in Brazil. There is no THP notified in Anvisa's system yet. There are 214 HM classified as nonprescription (OTC), while 145 are sold under prescription, one of them with prescription retention. There are 101 plant species licensed as active in HM in Brazil, 39 of which are native, adapted or cultivated. The most licensed plant species is Mikania glomerata Spreng., with 25 HM licensed. The article includes tables with plant species that have derivatives licensed as simple and combined HM, their therapeutic classification, the native plant species indication and the distribution of the companies by Brazilian regions.

There are few licensed HM in Brazil, and this number has been decreasing in recent years. It is expected that the data obtained, together with the changes promoted in sanitary and environmental rules, will help to develop and regulate HMP chain in Brazil.

The aim of this study was to evaluate the performance of nurses in the prescription of hormonal reversible contraceptives in Primary Care. A descriptive and transversal study was conducted, with 64 nurses at healthcare units as subjects, in the period of September-November 2010 in the county of Rio Branco-Acre. Data were collected through structured interviews using a questionnaire. The results showed that 96.9% of nurses are prescribing hormonal contraceptives and that the majority (90.6%) is aware of the government laws about nursing prescription. We also observed that the contraceptive was chosen based on client's decision and anamnesis (36% and 34% respectively), and that 90% of the nurses always give orientation about advantages and disadvantages of each contraceptive method. Thus, for choosing a contraceptive method based on given information and free will, the methods must be available and dispensed by trained professionals, after correct and complete orientation.

Passiflora alata is a Southern American species that constitutes many traditional remedies as well as phytomedicines used for sedative and anxiolytic purposes in Brazil. However studies on repeated treatment effects are scarce.

To evaluate behavioral, physiological and biochemical effects of the repeated treatment with an aqueous spray-dried extract of Passiflora alata leaves containing 2.5% (w/v) of flavonoids (PA) in mice.

Male adult CF1 mice were treated (p.o.) for 14 days with PA (2.5; 25 or 250 mg/kg). The feeding behavior was evaluated at the beginning (1h after the first administration) and at the end of the treatment (15th day). The body weight gain and food consumption were monitored along the days. On day 15 mice were evaluated on plus maze, spontaneous locomotor activity, catalepsy and barbiturate sleeping time tests. Serum glucose, lipids, ALT and AST enzymes were determined. Liver, kidney, perirenal fat, epididymal and peritoneal fat were analyzed.

The repeated treatment with the highest dose tested (250 mg/kg) did not alter the mice behavior on open field, elevated plus maze, catalepsy and barbiturate sleeping time tests. Repeated administration of PA 250 decreased mice feeding behavior and weight gain. PA 25 and PA 250 reduced mice relative liver weight and caused mild hepatic hydropic degeneration as well as a decrease in alanine aminotransferase (ALT) serum level.

These results indicate that Passiflora alata does not present central cumulative effects and point to the needs of further studies searching for its hepatotoxicity as well as potential anorexigenic.