Research On Adverse Drug Events And Reports Research Articles

35171 Malignant melanoma cases associated with IL-23 inhibitors: Pharmacovigilance analysis of real-world evidence in the Food and Drug Administration Adverse Event Reporting System (FAERS) from the RADAR (Research on Adverse Drug events And Reports) program

Background: IL-23 effects on tumorigenesis is suggestive, but remains unknown. The aim of this study was to determine if a safety signal is detectable for IL-23 inhibitor exposure and malignant melanoma in the FAERS database. Methods: Using MedDra terms for malignant melanoma, the FAERS database (for each FDA product approval date through Q4 2020) was analyzed using Proportional Reporting Ratio (PRR) for detection of a safety signal after exposure to risankizumab, guselkumab or tildrakizumab individually and as a class of drugs. PRR is defined as number of events >3, χ2 > 4 and PRR > 2. Results: A safety signal was detected for IL-23 inhibitors as a class (N = 17; PRR: 3.52; 95% CI 2.19-5.66) as well as for risankizumab (N = 9; PRR: 9.11; 95% CI 4.75-17.45), but not for guselkumab (N = 8; PRR: 2.17; 95% CI 1.09-4.35) or tidrakizumab (no cases). Conclusion Based on the findings from this real-world evidence, there is an increased risk for melanoma subsequent to exposure to an IL-23 inhibitor. Further evidence from large patient populations is warranted to better define this serious new risk.

35128 Cerebrovascular accident events associated with IL-23 inhibition: Pharmacovigilance analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) from the RADAR (Research on Adverse Drug Events And Reports) Program

Background: IL-23 inhibitors, risankizumab, guselkumab, and tildrakizumab, are approved systemic therapies for adults with moderate-to-severe plaque psoriasis. Although an increased risk for cerebrovascular accidents (CVAs) has been reported with exposure to combined IL-12/IL-23 inhibition in patients with cardiovascular risk, such evidence for IL-23 inhibition as monotherapy remains unaddressed. The aim of this study was to determine if a safety signal is detectable in the FAERS database for IL-23 inhibitors and subsequent CVAs.

Incidence of cutaneous T-cell lymphoma (CTCL) after chronic exposure to thiazides: pharmacovigilance analysis from the RADAR (Research on Adverse Drug events And Reports) Program

Incidence of cutaneous T-cell lymphoma (CTCL) after chronic exposure to thiazides: pharmacovigilance analysis from the RADAR (Research on Adverse Drug events And Reports) Program

Frequency of depression in dermatologist-managed patients who have acne, isotretinoin-exposure vs no isotretinoin exposure: Pharmacovigilance analysis of a large Midwestern US population from the RADAR (Research on Adverse Drug events And Reports) program

Frequency of depression in dermatologist-managed patients who have acne, isotretinoin-exposure vs no isotretinoin exposure: Pharmacovigilance analysis of a large Midwestern US population from the RADAR (Research on Adverse Drug events And Reports) program

Bullous skin disorders associated with PD-1 and PDL-1 inhibitors: Pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) from the Research on Adverse Drug events And Reports (RADAR) Program

Bullous skin disorders associated with PD-1 and PDL-1 inhibitors: Pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) from the Research on Adverse Drug events And Reports (RADAR) Program

Incidence of cutaneous adverse events after exposure to tenofovir-emtricitabine in HIV-uninfected vs HIV-infected patients: Pharmacovigilance analysis of a large Midwestern US patient population from the RADAR (Research on Adverse Drug events And Reports)

Incidence of cutaneous adverse events after exposure to tenofovir-emtricitabine in HIV-uninfected vs HIV-infected patients: Pharmacovigilance analysis of a large Midwestern US patient population from the RADAR (Research on Adverse Drug events And Reports)

Hyperkalemia in women with acne exposed to oral spironolactone: A retrospective study from the RADAR (Research on Adverse Drug Events and Reports) program.

PurposeThe necessity of serum potassium monitoring for healthy women who are prescribed spironolactone for acne has been debated. The aim of this study was to compare the incidence of hyperkalemia in women 18 to 45 years of age to that in women 46 to 65 years of age, when treated with oral spironolactone for acne.Methods and materialsData for all women 18 to 65 years of age who were prescribed oral spironolactone by a dermatologist for acne between January 2006 and October 2016 were extracted for analysis. Retrospective data were included for women who exhibited baseline serum potassium within the normal limits and who had repeat serum potassium monitoring within 12 months after initiation of spironolactone. The rate of incident hyperkalemia was determined.ResultsOf 618 women who received spironolactone for acne, 133 had serum potassium monitoring both before and after spironolactone initiation. Nine were excluded due to confounding comorbidities. Of the remaining 124 women, the mean age at initiation of spironolactone was 32 years (range, 18-57 years); 112 women were in the 18 to 45 years age group, and 12 were in the 46 to 65 years age group. All women had serum potassium within normal limits at baseline. Women in the 46 to 65 years age group had a significantly higher rate of incident hyperkalemia after spironolactone initiation compared with women 18 to 45 years of age (2 of 12 women [16.7%] vs. 1 of 112 women [< 1%]; p = .0245).ConclusionsAlthough controversy surrounds the clinical utility of serum potassium monitoring in healthy women exposed to spironolactone for acne, based on the findings from this large patient population, monitoring of serum potassium is warranted for women over 45 years of age given an age-related greater risk of hyperkalemia.

718 Hydroxychloroquine and cardiovascular events in patients with morphea: A report from the RADAR (Research on Adverse Drug events And Reports) program

718 Hydroxychloroquine and cardiovascular events in patients with morphea: A report from the RADAR (Research on Adverse Drug events And Reports) program

674 Hair loss and psychoactive medications: Stimulants and antidepressants: A retrospective analysis from the RADAR (Research on Adverse Drug events And Reports) Program

674 Hair loss and psychoactive medications: Stimulants and antidepressants: A retrospective analysis from the RADAR (Research on Adverse Drug events And Reports) Program

Melanoma subsequent to natalizumab exposure: A report from the RADAR (Research on Adverse Drug events And Reports) program

Melanoma subsequent to natalizumab exposure: A report from the RADAR (Research on Adverse Drug events And Reports) program

LB1501 Chronic exposure to statin drugs and association with melanoma: A report from the RADAR (Research on Adverse Drug Events and Reports) project

LB1501 Chronic exposure to statin drugs and association with melanoma: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Inflammatory bowel disease events after exposure to the interleukin-17 inhibitors ixekizumab and secukinumab: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Inflammatory bowel disease events after exposure to the interleukin-17 inhibitors ixekizumab and secukinumab: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Chronic daily dosing of PDE5 inhibitors (sildenafil or tadalafil) for pulmonary hypertension and risk of subsequent melanoma: A report from the Research on Adverse Drug Events and Reports (RADAR) project

Chronic daily dosing of PDE5 inhibitors (sildenafil or tadalafil) for pulmonary hypertension and risk of subsequent melanoma: A report from the Research on Adverse Drug Events and Reports (RADAR) project

Pyoderma gangrenosum subsequent to tumor necrosis factor α inhibitor exposure: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Pyoderma gangrenosum subsequent to tumor necrosis factor α inhibitor exposure: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Inflammatory bowel disease events after exposure to interleukin 17 inhibitors secukinumab and ixekizumab: Postmarketing analysis from the RADAR (“Research on Adverse Drug events And Reports”) program

Inflammatory bowel disease events after exposure to interleukin 17 inhibitors secukinumab and ixekizumab: Postmarketing analysis from the RADAR (“Research on Adverse Drug events And Reports”) program

242 Risk of nonmelanoma skin cancer after exposure to statin drugs: A report from the RADAR (Research on Adverse Drug events and Reports) project

Statin exposure and nonmelanoma skin cancer (NMSC) association is unclear. The aim of this study is to determine if there is an association between statin exposure and NMSC [basal cell cancer (BCC) and squamous cell cancer (SCC)], in a large patient population. The Northwestern Medicine Enterprise Data Warehouse medical record data repository (> 5 million patients) was searched for patients aged 18-89 years with at least 5 years of in-clinic follow-up. The statin-exposed population consisted of all patients taking a chronic statin medication (atorvastatin, cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin) for at least 12 months, while the control population consisted of non-statin-exposed patients. Data on age, gender, race, and NMSC diagnosis were collected. Adjusted odds ratios (aORs) were determined by multivariate logistic regression. Of 440,289 patients meeting inclusion criteria, 56,117 had statin exposure, of whom 3,590 (6.4%) were diagnosed with NMSC, yielding a significant association between NMSC and statin exposure (aOR: 2.39; 95%CI 2.30-2.49; p < 0.0001). Data for the 40 to 75-year-old group chosen to follow recent statin recommendations from US Preventative Services Task Force also showed a significant association between statin exposure and subsequent NMSC diagnosis (aOR: 1.63; 95%CI 1.56-1.70; p < 0.0001). In addition, statin exposure and subsequent diagnoses of BCC or SCC were examined in separate populations. This yielded further significant associations between statin exposure and subsequent BCC diagnosis (aOR: 1.46; 95%CI 1.38-1.53; p < 0.0001), as well as subsequent SCC diagnosis (aOR: 2.12; 95%CI 1.97-2.29; p < 0.0001). These findings highlight an association between chronic statin exposure and subsequent incident NMSC in the study population.

LB953 Spironolactone and psoriasis outcome in young adult women: A report from the RADAR (Research on Adverse Drug events And Reports) project

LB953 Spironolactone and psoriasis outcome in young adult women: A report from the RADAR (Research on Adverse Drug events And Reports) project

Infection rate in patients with psoriasis exposed to oral apremilast versus other oral agents (acitretin, cyclosporine, and methotrexate): A report from the RADAR (Research on Adverse Drug events And Reports) project

Infection rate in patients with psoriasis exposed to oral apremilast versus other oral agents (acitretin, cyclosporine, and methotrexate): A report from the RADAR (Research on Adverse Drug events And Reports) project

Rate of all infection for ustekinumab versus standard oral systemic therapeutic agents (acitretin, cyclosporine, or methotrexate) in the management of psoriasis: A report from the RADAR (Research on Adverse Drug events And Reports) project

Rate of all infection for ustekinumab versus standard oral systemic therapeutic agents (acitretin, cyclosporine, or methotrexate) in the management of psoriasis: A report from the RADAR (Research on Adverse Drug events And Reports) project

Chronic exposure to tetracyclines and association with subsequent nonmelanoma skin cancer: A report from the RADAR (Research on Adverse Drug events And Reports) project

Chronic exposure to tetracyclines and association with subsequent nonmelanoma skin cancer: A report from the RADAR (Research on Adverse Drug events And Reports) project