scholarly journals Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

Pharmacy ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 174
Author(s):  
Elina Amatya ◽  
Romano Fois ◽  
Kylie A. Williams ◽  
Lisa G. Pont
Keyword(s):  
Gastrointestinal Bleeding ◽  
Spontaneous Reporting ◽  
Fold Increase ◽  
Over The Counter ◽  
Risk Of Bleeding ◽  
Post Marketing Surveillance ◽  
Increased Risk ◽  
Otc Medicines ◽  
Reporting Data ◽  
Safety Signals

One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detecting safety signals for OTC medicines in National ADR spontaneous reporting data, using OTC non-steroidal anti-inflammatory drugs (NSAIDs) and gastrointestinal bleeding as an example. Data from the Australian Adverse Drug Reactions System (ADRS) dataset (1971–2008) and the Canadian Vigilance Adverse Reaction Online Database (VAROD) (1965–2013) were used to explore the feasibility of using spontaneous reporting data, exploring the association between gastrointestinal bleeding and the use of OTC NSAIDs. Safety signals were examined using disproportionality analyses and reporting odds ratios calculated. After adjusting for age, gender, medications known to increase the risk of bleeding, and medications used for the management of conditions associated with an increased risk of bleeding, a two-fold increase in the risk of gastrointestinal (GI) bleeding with OTC NSAID was observed within each dataset. This study demonstrates that spontaneous ADR reporting data can be used in pharmacovigilance to monitor the safety of OTC medicines.

scholarly journals Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial

Circulation ◽  
2020 ◽  
Vol 141 (1) ◽  
pp. 10-20 ◽  
Author(s):  
Frederik Dalgaard ◽  
Hillary Mulder ◽  
Daniel M. Wojdyla ◽  
Renato D. Lopes ◽  
Claes Held ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Gastrointestinal Bleeding ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Clinical Trial Registration ◽  
Risk Of Bleeding ◽  
Number Of Patients ◽  
Increased Risk ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

Background: The use of nonsteroidal anti-inflammatory drugs (NSAIDs) with oral anticoagulants has been associated with an increased risk of bleeding. We investigated the risk of bleeding and major cardiovascular outcomes in patients with atrial fibrillation taking NSAIDs and apixaban or warfarin. Methods: The ARISTOTLE trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; n=18 201) compared apixaban with warfarin in patients with atrial fibrillation at an increased risk of stroke. Patients in ARISTOTLE without severe renal (creatine clearance ≤30 mL/min) or liver disease were included in this analysis (n=17 423). NSAID use at baseline, NSAID use during the trial (incident NSAID use), and never users were described. The primary outcome was major bleeding. Secondary outcomes included clinically relevant nonmajor bleeding, gastrointestinal bleeding, heart failure hospitalization, stroke or systemic embolism, and all-cause mortality. NSAID use during the trial, and the interaction between randomized treatment, was analyzed using time-dependent Cox proportional hazards models. Results: Those with baseline NSAID use (n=832 [4.8%]), incident NSAID use (n=2185 [13.2%]), and never users were similar in median age (age [25th, 75th]; 70 [64, 77] versus 70 [63, 75] versus 70 [62, 76]). Those with NSAID use at baseline and incident NSAID use were more likely to have a history of bleeding than never users (24.5% versus 21.0% versus 15.6%, respectively). During a median follow-up (25th, 75th) of 1.8 (1.4, 2.3) years and when excluding those taking NSAID at baseline, we found that incident NSAID use was associated with an increased risk of major bleeding (hazard ratio [HR], 1.61 [95% CI, 1.11–2.33]) and clinically relevant nonmajor bleeding (HR, 1.70 [95% CI, 1.16–2.48]), but not gastrointestinal bleeding. No significant interaction was observed between NSAID use and randomized treatment for any outcome. Conclusions: A substantial number of patients in the ARISTOTLE trial took NSAIDs. Incident NSAID use was associated with major and clinically relevant nonmajor bleeding, but not with gastrointestinal bleeding. The safety and efficacy of apixaban versus warfarin appeared not significantly to be altered by NSAID use. This study warrants more investigation of the effect of NSAIDs on the outcomes of patients treated with apixaban. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00412984.

scholarly journals Risk of Bleeding with Exposure to Warfarin and Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 120 (07) ◽  
pp. 1066-1074
Author(s):  
Lorenzo Villa Zapata ◽  
Philip D. Hansten ◽  
Jennifer Panic ◽  
John R. Horn ◽  
Richard D. Boyce ◽  
...  
Keyword(s):  
Gastrointestinal Bleeding ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Healthcare Research ◽  
Average Treatment Effect ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Inflammatory Drugs ◽  
Cox 2 ◽  
Anti Inflammatory

Abstract Background Warfarin use can trigger the occurrence of bleeding independently or as a result of a drug–drug interaction when used in combination with nonsteroidal anti-inflammatory drugs (NSAIDs). Objectives This article examines the risk of bleeding in individuals exposed to concomitant warfarin and NSAID compared with those taking warfarin alone (Prospero Registry ID 145237). Methods PubMed, EMBASE, Scopus, and Web of Science were searched. The primary outcome of interest was gastrointestinal bleeding and general bleeding. Summary effects were calculated to estimate average treatment effect using random effects models. Heterogeneity was assessed using Cochran's Q and I 2. Risk of bias was also assessed using the Agency for Healthcare Research and Quality bias assessment tool. Results A total of 651 studies were identified, of which 11 studies met inclusion criteria for meta-analysis. The odds ratio (OR) for gastrointestinal bleeding when exposed to warfarin and an NSAID was 1.98 (95% confidence interval [CI]: 1.55–2.53). The risk of gastrointestinal bleeding was also significantly elevated with exposure to a COX-2 inhibitor and warfarin relative to warfarin alone (OR = 1.90, 95% CI: 1.46–2.46). There was an increased risk of general bleeding with the combination of warfarin with NSAIDs (OR = 1.58, 95% CI: 1.18–2.12) or COX-2 inhibitors (OR = 1.54, 95% CI: 0.86–2.78) compared with warfarin alone. Conclusion Risk of bleeding is significantly increased among persons taking warfarin and a NSAID or COX-2 inhibitor together as compared with taking warfarin alone. It is important to caution patients about taking these medications in combination.

scholarly journals Modern Approaches to Optimal Antithrombotic Therapy for Stable Ischemic Heart Disease

2020 ◽  
Vol 10 (5) ◽  
pp. 348-356
Author(s):  
G. E. Roytberg ◽  
I. D. Slastnikova
Keyword(s):  
Risk Factors ◽  
Gastrointestinal Bleeding ◽  
Antithrombotic Therapy ◽  
Adverse Outcomes ◽  
Diagnostic Methods ◽  
International Studies ◽  
Chronic Coronary Artery Disease ◽  
Risk Of Bleeding ◽  
Clinical Scenarios ◽  
Increased Risk

The article highlights the practical aspects of the use of antithrombotic therapy in patients with stable (chronic) coronary artery disease (САD). The САD verification using modern functional and anatomical diagnostic methods are considered. Patients with stable САD represent a heterogeneous group, having various clinical scenarios. Information is provided on the main risk factors for ischemic and hemorrhagic complications that determine the choice of optimal antithrombotic therapy regimens. Modern views on the monotherapy and clopidogrel in САD are presented. The data of the largest international studies CHARISMA and PEGASUS-TIMI 54 on the use of double antiplatelet therapy in patients with stable IHD reflected in modern guidelines are highlighted. Features of new antiplatelet agents (prasugrel and ticagrelol) are described. Based on the results of the COMPASS study, indications for the administration of small doses of rivaroxaban in combination with aspirin for the secondary prevention of cardiovascular complications in patients with stable manifestations of atherosclerosis with a low risk of bleeding are considered. The use of antithrombotic therapy is associated with an increased risk of bleeding and particularly with gastrointestinal bleeding. The information on the use of drugs for the prevention of gastrointestinal bleeding is provided.Antithrombotic therapy can reduce the risk of complications associated with atherothrombosis, however, to improve prognosis a multipurpose intervention is required, including correction of risk factors and the use of drugs from different groups with proven effectiveness. Optimal medical therapy, including antithrombotic drugs, is vital for patients with САD and can successfully prevent adverse outcomes.

Investigation Of Over The Counter (Otc ) Pharmaceutical Brands Prefered By New Age Indian Women

2019 ◽  
Vol 118 (4) ◽  
pp. 1-15
Author(s):  
Dr.G. Madhumita ◽  
Dr.G. Rajini ◽  
Dr.B. Subisha
Keyword(s):  
Pharmaceutical Company ◽  
Medical Practitioner ◽  
New Age ◽  
The Other ◽  
Pharmaceutical Companies ◽  
Brand Preference ◽  
Over The Counter ◽  
Indian Women ◽  
Prescription Medicines ◽  
Otc Medicines

The study investigates the preference of OTC Medicines among the pharmaceutical brand.OTC Medicines means medicines lawfully permitted to sell  “Over the Counter”, i.e. devoid of the prescription of a Registered Medical Practitioner. In India, although the expression has no lawful acknowledgment, all the medicines that are not incorporated in the list of ‘prescription only medicines’ are measured as non-prescription medicines (or OTC Medicines).Pharmaceutical over the counter products (OTC) be the medicines which can be sold without prescription. Also termed as “Non Prescription Medicines” discussed by Arti(2010).This article talks about top pharmaceutical company brands Aventis Pharma, GlaxoSmithKline, Surya Pharma, Torrent Pharma,Glenmark,Divis Labs,Biocon, Orchid Chemical, Abbott Indi, Sterling Bio, Alembic Pharma etc, the brand preference of New Age Indian Women. A 736 questionnaire was composed of different age and different New Age Indian Women in around Urban :Chennai ;Semi Urban :Neyveli ; Rural :Soolurpet ;Tirupur. The findings of the study shows that the highest preferred generic brand is balms,  Medicines chosen  for fever is Crocin, Idoex  is most ideal pain blams, volini spray is also most preferred brand, ENO is ideal Antacid brand, Sadiron is another chosen brand for cough and cold, the other brands are Metfal SPS, Johnson, Revital are the other favored brands. The study will be a great instrument for the pharmaceutical companies brands to understand today’s New Age Indian Women.

Comparative Efficacy and Safety of Duration of Dual Antiplatelet Therapy in Patients with CAD Undergoing Drug-eluting Stent Implantation: A Systematic Review and Network Meta-analysis

2020 ◽  
Vol 26 (44) ◽  
pp. 5739-5745
Author(s):  
Jieqiong Guan ◽  
Wenjing Song ◽  
Pan He ◽  
Siyu Fan ◽  
Hong Zhi ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Dual Antiplatelet Therapy ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Drug Eluting Stent ◽  
Efficacy And Safety ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Drug Eluting

Objective: The aim was to evaluate the efficacy and safety of duration of dual antiplatelet therapy (DAPT) for patients who received percutaneous coronary intervention (PCI) with a drug-eluting stent. Background: The optimal duration of DAPT to balance the risk of ischemia and bleeding in CAD patients undergoing drug-eluting stent (DES) implantation remains controversial. Methods: PubMed, Cochrane Library, Web of Science, Clinicaltrials.gov, CNKI and Wanfang Databases were searched for randomized controlled trials of comparing different durations of DAPT after DES implantation. Primary outcomes were major adverse cardiac and cerebrovascular events (MACCE), and major bleeding, and were pooled by Bayes network meta-analysis. Net adverse clinical and cerebral events were used to estimate the surface under the cumulative ranking (SUCRA) curves. The subgroup analysis based on clinical status, follow-up and area was conducted using traditional pairwise meta-analysis. Results: A total of nineteen trials (n=51,035) were included, involving six duration strategies. The network metaanalysis showed that T2 (<6-month DAPT followed by aspirin, HR:1.51, 95%CI:1.02-2.22), T3 (standard 6-month DAPT, HR:1.47, 95%CI:1.14-1.91), T4 (standard 12-month DAPT, HR:1.41, 95%CI:1.15-1.75) and T5 (18-24 months DAPT, HR:1.47, 95%CI:1.09-1.97) was associated with significantly increased risk of MACCE compared to T6 (>24-month DAPT). However, no significant difference was found in MACCE risk between T1 (<6-month DAPT followed by P2Y12 monotherapy) and T6. Moreover, T5 was associated with significantly increased risk of bleeding compared to T1(RR:3.94, 95%CI:1.66-10.60), T2(RR:3.65, 95%CI:1.32-9.97), T3(RR:1.93, 95%CI:1.21-3.50) and T4(RR:1.89, 95%CI:1.15-3.30). The cumulative probabilities showed that T6(85.0%), T1(78.3%) and T4(44.5%) were the most efficacious treatment compared to the other durations. In the ACS (<50%) subgroup, T1 was observed to significantly reduce the risk of major bleeding compared to T4, but not in the ACS (≥50%) subgroup. Conclusions: Compared with other durations, short DAPT followed by P2Y12 inhibitor monotherapy showed non-inferiority, with a lower risk of bleeding and not associated with an increased MACCE. In addition, the risk of major bleeding increased significantly, starting with DAPT for 18-month. Compared with the short-term treatment, patients with ACS with the standard 12-month treatment have a better prognosis, including lower bleeding rate and the decreased risk of MACCE. Due to study's limitations, the results should be verified in different risk populations.

scholarly journals Future Pharmacists’ Opinions on the Facilitation of Self-Care with Over-the-Counter Products and Whether This Should Remain a Core Role

Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 132
Author(s):  
Lezley-Anne Hanna ◽  
Alana Murphy ◽  
Maurice Hall ◽  
Rebecca Craig
Keyword(s):  
Emergency Contraception ◽  
Self Care ◽  
Pharmacy Students ◽  
Single Institution ◽  
Self Medication ◽  
Over The Counter ◽  
Otc Medicines ◽  
Practice Methods ◽  
Identifiable Data

Background: The aim was to investigate pharmacy students’ views on the role of the pharmacist in facilitating self-care with over-the-counter (OTC) medicines, particularly in light of new roles, and establish personal practice. Methods: Final year pharmacy students at Queen’s University Belfast were invited to participate. Data were collected via a pre-piloted questionnaire, distributed at a compulsory class (only non-identifiable data were requested). Descriptive statistics were performed, and non-parametric tests were employed for inferential statistical analysis (responses by gender). Results: The response rate was 87.6% (78/89); 34.6% (27/78) males and 65.4% (51/78) females. Over a third [34.6% (27/78)] reported using OTC medicines about once a month. All appreciated the importance of an evidence-based approach to optimize patient care. Most [(96.2% (75/78)] deemed OTC consultations should remain a fundamental responsibility of pharmacists and 69.2% (54/78) thought OTC consultations have the potential to be as complex as independent pharmacist prescribing. Females felt more confident recommending OTC emergency contraception than males (p = 0.002 for levonorgestrel and p = 0.011 for ulipristal acetate). Many [61.5% (48/78)] considered more medicines should not be deregulated from prescription-only status. Conclusions: Data from this single institution suggests that enabling self-medication is an important part of practice but there were confidence issues around deregulations.

A case of minimal change disease during pregnancy – Benefits of early diagnosis and use of corticosteroids

2021 ◽  
pp. 1753495X2199021
Author(s):  
Priyanka S Sagar ◽  
Eddy Fischer ◽  
Muralikrishna Gangadharan Komala ◽  
Bhadran Bose
Keyword(s):  
Nephrotic Syndrome ◽  
Early Diagnosis ◽  
Renal Biopsy ◽  
Early Pregnancy ◽  
Minimal Change Disease ◽  
Minimal Change ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Prompt Diagnosis ◽  
In Pregnancy

Nephrotic syndrome presenting in pregnancy is rare and poses a diagnostic and therapeutic challenge. Timing of renal biopsy is important given the increased risk of bleeding and miscarriage, and the choice of immunosuppression is limited due to the teratogenicity profiles of standard drugs. We report and discuss a case of minimal change disease diagnosed by renal biopsy during early pregnancy and treated with corticosteroids throughout the pregnancy. Prompt diagnosis and treatment of glomerular disease in pregnancy are vital to prevent poor maternal and fetal outcomes.

scholarly journals Upper GI Bleeding Secondary to Radiation Gastritis in a Patient with Preexisting Portal Hypertensive Gastropathy

2021 ◽  
pp. 513-518
Author(s):  
Samragnyi Madala ◽  
Abhishek Polavarapu ◽  
Dhineshreddy Gurala ◽  
Vivek Gumaste
Keyword(s):  
Radiation Therapy ◽  
Gastrointestinal Bleeding ◽  
Argon Plasma Coagulation ◽  
Argon Plasma ◽  
Laser Coagulation ◽  
Portal Hypertensive Gastropathy ◽  
Gastrointestinal Malignancy ◽  
Nonalcoholic Fatty Liver ◽  
Increased Risk ◽  
Radiation Induced

We commonly see patients presenting with either portal hypertensive gastropathy (PHG) or radiation gastritis. Radiation-induced hemorrhagic gastritis is an unusual lethal complication postradiation. Patients with preexisting PHG have very friable mucosa that can easily bleed after radiation for cancer treatment. There is an increased risk of bleeding with both entities present together. Our aim is to focus on treatment and possible prevention of gastrointestinal bleeding in patients with preexisting PHG undergoing radiation therapy for newly diagnosed cancer. Several therapies like prednisolone, argon plasma coagulation, laser coagulation have been proposed. There are no set guidelines for treatment. In these patients, if radiation therapy is indicated either for hepatic or gastrointestinal malignancy, it is suggested to premedicate with proton pump inhibitors or sucralfate. We describe a case of 73-year-old female who presented with upper gastrointestinal bleeding. She had liver cirrhosis secondary to nonalcoholic fatty liver disease and diagnosed with pancreatic cancer, for which she received chemoradiation. She was found to have both radiation gastritis and PHG with diffuse erythematous, edematous, congested mucosa with diffuse oozing blood in the antrum making it very challenging to treat.

Complex antithrombotic therapy and bleeding risk in patients with peripheral arterial disease

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tseng ◽  
S Bhatt ◽  
M Girardo ◽  
D Liedl ◽  
P Wennberg ◽  
...  
Keyword(s):  
Peripheral Arterial Disease ◽  
Triple Therapy ◽  
Major Bleeding ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Arterial Disease ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Peripheral Arterial

Abstract Introduction Antiplatelet therapy is the cornerstone of treatment for many atherosclerotic vascular pathologies including peripheral arterial disease (PAD). Patients with PAD often have comorbid conditions that require complex antithrombotic therapy, i.e. combined antiplatelet and anticoagulation. Methods All adult patients undergoing ankle brachial index (ABI) measurements were included in the study. ABI values between 1.00 and 1.40 were considered normal, and values below 1.00 or above 1.40 were considered PAD. Demographic, comorbidity and outcome data were obtained using diagnostic codes from the electronic health record. Three medication classes were analyzed: aspirin, non-aspirin oral antiplatelets (e.g. P2Y12 inhibitors) and oral anticoagulants (warfarin and the direct oral anticoagulants). Medication use was determined for patients who had been on a medication for at least one year. Cox proportional hazard analysis for the time to first bleeding event was analyzed. Bleeding was defined as any bleeding requiring medical evaluation (including clinically-relevant non-major bleeding and major bleeding). Results In all, 40,144 patients were included in the analysis (mean age 66±15, 43% female). Patients with PAD were more likely to be on double therapy (one antiplatelet with anticoagulation) (28% vs 19%) and triple therapy (dual antiplatelet with anticoagulation) (10% vs 4%). Unadjusted hazard ratios for bleeding risk showed increased risk of bleeding for patients with PAD (1.18, 95% confidence interval [CI]: 1.08–1.29), though the association is no longer present after adjustment for antithrombotic therapy. Adjusting for age, sex and PAD class, compared to no antithrombotic therapy, there was increased risk of bleeding for monotherapy (1.91, 95% CI: 1.61–2.26), double therapy (3.40, 95% CI: 2.89–4.00) and triple therapy (5.00, 95% CI: 4.21–5.96). Among medications, aspirin and anticoagulant use was independently associated with the greatest increase in risk of bleeding. Conclusion Patients in PAD are at increased risk of bleeding secondary to antithrombotic therapy. Complex antithrombotic therapy with double or triple therapy confer additional bleeding risk, particularly regimens containing aspirin and oral anticoagulants. Funding Acknowledgement Type of funding source: None

scholarly journals Fetal CHD and perinatal outcomes

2020 ◽  
Vol 30 (5) ◽  
pp. 686-691
Author(s):  
Christina J. Ge ◽  
Amanda C. Mahle ◽  
Irina Burd ◽  
Eric B. Jelin ◽  
Priya Sekar ◽  
...  
Keyword(s):  
Cohort Study ◽  
Preterm Delivery ◽  
Odds Ratio ◽  
Retrospective Cohort ◽  
Mode Of Delivery ◽  
Perinatal Outcomes ◽  
Fold Increase ◽  
Cesarean Sections ◽  
Increased Risk ◽  
Gestational Age At Delivery

AbstractObjective:To evaluate delivery management and outcomes in fetuses prenatally diagnosed with CHD.Study design:A retrospective cohort study was conducted on 6194 fetuses (born between 2013 and 2016), comparing prenatally diagnosed with CHD (170) to those with non-cardiac (234) and no anomalies (5790). Primary outcomes included the incidence of preterm delivery and mode of delivery.Results:Gestational age at delivery was significantly lower between the CHD and non-anomalous cohorts (38.6 and 39.1 weeks, respectively). Neonates with CHD had a significantly lower birth weights (p < 0.001). There was an approximately 1.5-fold increase in the rate of primary cesarean sections associated with prenatally diagnosed CHD with an odds ratio of 1.49 (95% CI 1.06–2.10).Conclusions:Our study provides additional evidence that the prenatal diagnosis of CHD is associated with a lower birth weight, preterm delivery, and with an increased risk of delivery by primary cesarean section.

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