Clinical outcome data of chronic pain patients treated with cannabis-based oils and dried flower from the UK Medical Cannabis Registry.

BACKGROUND: The following study evaluated the clinical outcomes of patients enrolled in the UK Medical Cannabis Registry, who were treated with inhaled dried flower (Adven® EMT2, Curaleaf International, Guernsey), and sublingual/oral medium-chain triglyceride-based oils (Adven, Curaleaf International, Guernsey) for chronic pain. METHODS: In this cohort study, the primary outcomes were changes in validated patient reported outcome measures (PROMs) at 1, 3, and 6 months compared to baseline, and adverse event analysis. Statistical significance was defined as p < 0.050. RESULTS: Three hundred and forty-eight (45.7%), 36 (4.7%), and 377 (49.5%) patients were treated with oils, dried flower, or both, respectively. Patients treated with oils or combination therapy recorded improvements within health-related quality of life, pain, and sleep-specific PROMs at 1, 3, and 6 months (p < 0.050). Patients treated with combination therapy recorded improvements in anxiety-specific PROMs at 1, 3, and 6 months (p < 0.050). 1,273 (167.3%) adverse events were recorded, with previously cannabis naïve users, ex-cannabis users, and females more likely to experience adverse events (p < 0.050). CONCLUSIONS: This study observed an association between initiation of CBMP treatment and improved outcomes for chronic pain patients. Prior cannabis use and gender were associated with adverse event incidence. Placebo-controlled trials are still necessary to establish the efficacy and safety of CBMPs for chronic pain.

A critical review of the respiratory benefits and harms of orally administered opioids for dyspnea management in COPD.

INTRODUCTION: Dyspnea occurring in chronic obstructive pulmonary disease (COPD) that is refractory to traditional management strategies is a common and challenging problem. Considerable attention has been paid to the off-label use of orally administered opioids as a pharmacotherapy option for refractory dyspnea in COPD. Multiple professional respiratory society guidelines express support for the application of oral opioids for this purpose. AREAS COVERED: This manuscript will critically review randomized controlled trials undertaken to date that evaluate the efficacy of oral opioids for dyspnea in COPD, as well as phase IV observational studies that examine for potential opioid-related respiratory harms in the COPD population (literature was searched on PubMed up to June 2021). COPD guideline recommendations relating to opioids for dyspnea will subsequently be critiqued. EXPERT OPINION: Opioid efficacy trials demonstrate at best a small improvement in dyspnea in limited numbers of individuals with COPD, whereas safety trials consistently show an increased risk of respiratory-related exacerbation, hospitalization and death in association with opioid use. In contrast to what is expressed in guidelines, the current body of evidence does not the support the wide application of opioids to manage refractory dyspnea among individuals with COPD, but instead, a highly selective and careful approach.

Adverse event analysis and renal safety comparison of tenofovir disoproxil and tenofovir alafenamide based on FAERS database / 药物流行病学杂志

Objective To explore the adverse events and renal safety of tenofovir disoproxil(TD)and tenofovir alafenamide(TA)by data mining from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,so as to provide reference for clinical drug safety.Methods The adverse events of TD and TA reported in FAERS database between the first quarter of 2004 and the first quarter of 2023 were analyzed with the methods of the reporting odds ratio(ROR)method,proportional reporting ratio(PRR)method,the Medicines and Healthcare products Regulatory Agency(MHRA)method,and Bayesian Confidence Propagation Neural Network(BCPNN)method.The distribution and intensity of risk signals of the data were analyzed,and the SMQ search tool was employed to conduct in-depth analysis of"acute renal failure"and"chronic kidney disease".Results A total of 19 530 and 1 587 reports were extracted as primary suspect drugs for TD and TA.There were more males than females were found in reports,and the age was concentrated in 45-65 years old,and the number of signals satisfying the four excavation methods was 185 and 68,respectively.The high-frequency adverse event distribution showed significant differences between TD and TA.The main risk signals of TD were bone and renal diseases,manifested as decreased bone density,bone injury,osteoporosis,chronic kidney disease,and renal failure.The main risk signals of TA was systemic disease with few reports of bone and renal damage,most of which were negative signals.Further analysis of renal safety showed similar results.Conclusion There are certain differences in terms of high-frequency adverse events,systemic organ distribution,and overall safety between TD and TA,especially the safety of renal and bone.Patients with pre-existing renal and bone diseases prefer TA to TD,however,the short time to market and the deviation caused by the small number of reports for TA,the safety of the two drugs should be continuously paid attention to.

Interplay of the Quality of Ciprofloxacin and Antibiotic Resistance in Developing Countries.

Ciprofloxacin, a second generation broad spectrum fluoroquinolone, is active against both Gram-positive and Gram-negative bacteria. Ciprofloxacin has a high oral bioavailability and a large volume of distribution. It is used for the treatment of a wide range of infections including urinary tract infections caused by susceptible bacteria. However, the availability and use of substandard and spurious quality of oral ciprofloxacin formulations in the developing countries has been thought to have contributed toward increased risk of treatment failure and bacterial resistance. Therefore, quality control and bioequivalence studies of the commercially available oral ciprofloxacin formulations should be monitored. Appropriate actions should be taken against offending manufacturers in order to prevent the sale of substandard and spurious quality of ciprofloxacin formulations.

Nimesulide induced leukocytoclastic vasculitis and hepatitis: a case report.

BACKGROUND: Nimesulide is a non-steroidal anti-inflammatory drug with antipyretic and analgesic properties, which is still used in many countries despite its known hepatotoxicity. Along with hepatotoxicity it has also been associated with several other Adverse Drug Reactions (ADRs) including leukocytoclastic vasculitis (LCV). CASE DESCRIPTION: A 38 year-old female presented with history of acute onset fever for which she took tablet nimesulide and paracetamol combination (100 mg Nimesulide + 500 mg paracetamol tablet), 1 tab three times daily for 4 days, following which she developed rash all over the body. She also had clinical and biochemical evidence of acute hepatitis. Histopathological examination of the skin rash documented the presence of LCV. She was managed symptomatically with anti-inflammatory and supportive therapy and was not further exposed to nimesulide. DISCUSSION AND EVALUATION: Our case demonstrates occurrence of acute hepatitis and LCV associated with nimesulide intake. The case meets the defining criteria for the diagnosis of LCV preceded by history of nimesulide intake. There was also clinical and biochemical evidence of hepato-cellular damage which supports the concurrent development of hepatitis along with the development of LCV following nimesulide use. To the best of our knowledge there is no previous published report of LCV and hepatitis occurring concurrently in the same patient following nimesulide intake. Nimesulide should be added to the list of agents associated with these serious adverse drug reactions. CONCLUSIONS: Nimesulide has been a contentious drug over many years. Under such evidence of serious ADRs the scientific community should consider ensuring strict pharmacovigilance with respect to its use especially in the developing countries where such monitoring systems are inadequate.

Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women.

OBJECTIVE: To describe the safety of ulipristal acetate in emergency contraception. STUDY DESIGN: Postmarketing pharmacovigilance data collection. RESULTS: A total of 553 women experienced 1049 adverse drug reactions. The most frequent (n,%) were pregnancies (282, 6.8%); nausea, abdominal pain and vomiting (139, 13.3%); headache, dizziness (67, 6.4%); and metrorrhagia, menses delay and breast symptoms (84, 8.0%). Including data from clinical trials, 376 pregnancies have been reported in total, 232 (62%) with a known outcome: 28 live births (29 newborns), 34 miscarriages, 151 induced abortions, 4 ectopics and 15 which are ongoing. CONCLUSIONS: No safety concern emerges from a sizable database of reported adverse reactions following ulipristal acetate exposure among varying ethnicities and regions. Postapproval data confirm the safety profile described during the clinical trials. IMPLICATIONS: Use of ulipristal acetate for emergency contraception in a variety of settings and among diverse populations indicate that it is safe and without unexpected or serious adverse events.