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Medications mostly associated with priapism events: assessment of the 2015–2020 Food and Drug Administration (FDA) pharmacovigilance database entries

DOI:10.1038/s41443-022-00583-3
Authors:
Nicolò Schifano at San Raffaele Scientific Institute
Nicolò Schifano
Paolo Capogrosso at San Raffaele Scientific Institute
Paolo Capogrosso
Luca Boeri at Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Luca Boeri
Giuseppe Fallara at San Raffaele Scientific Institute
Giuseppe Fallara
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Abstract

A range of drugs have a direct role in triggering ischaemic priapism. We aimed at identifying: a) which medications are associated with most priapism-reports; and, b) within these medications, comparing their potential to elicit priapism through a disproportionality analysis. The FDA Adverse Event Reporting System (FAERS) database was queried to identify those drugs associated the most with priapism reports over the last 5 years. Only those drugs being associated with a minimum of 30 priapism reports were considered. The Proportional Reporting Ratios (PRRs), and their 95% confidence intervals were computed. Out of the whole 2015–2020 database, 1233 priapism reports were identified, 933 of which (75.7%) were associated with 11 medications with a minimum of 30 priapism-reports each. Trazodone, olanzapine and tadalafil showed levels of disproportionate reporting, with a PRR of 9.04 (CI95%: 7.73–10.58), 1.55 (CI95%: 1.27–1.89), and 1.42 (CI95%: 1.10–1.43), respectively. Most (57.5%) of the reports associated with the phosphodiesterase type 5 inhibitors (PDE5Is) were related with concomitant priapism-eliciting drugs taken at the same time and/or inappropriate intake/excessive dosage. Patients taking trazodone and/or antipsychotics need to be aware of the priapism-risk; awareness among prescribers would help in reducing priapism-related detrimental sequelae; PDE5I-intake is not responsible for priapism by itself, when appropriate medical supervision is provided.
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ARTICLE
Medications mostly associated with priapism events:
assessment of the 2015–2020 Food and Drug Administration
(FDA) pharmacovigilance database entries
Nicolò Schifano
1,2
, Paolo Capogrosso
3
, Luca Boeri
2,4
, Giuseppe Fallara
1,2
, Omer Onur Cakir
5,6
, Fabio Castiglione
5,6
,
Hussain M. Alnajjar
5,6
, Asif Muneer
5,6
, Federico Deho’
3
, Fabrizio Schifano
7
, Francesco Montorsi
1,2
and Andrea Salonia
1,2
✉
© The Author(s), under exclusive licence to Springer Nature Limited 2022
A range of drugs have a direct role in triggering ischaemic priapism. We aimed at identifying: a) which medications are associated
with most priapism-reports; and, b) within these medications, comparing their potential to elicit priapism through a
disproportionality analysis. The FDA Adverse Event Reporting System (FAERS) database was queried to identify those drugs
associated the most with priapism reports over the last 5 years. Only those drugs being associated with a minimum of 30 priapism
reports were considered. The Proportional Reporting Ratios (PRRs), and their 95% confidence intervals were computed. Out of the
whole 2015–2020 database, 1233 priapism reports were identified, 933 of which (75.7%) were associated with 11 medications with
a minimum of 30 priapism-reports each. Trazodone, olanzapine and tadalafil showed levels of disproportionate reporting, with a
PRR of 9.04 (CI95%: 7.73–10.58), 1.55 (CI95%: 1.27–1.89), and 1.42 (CI95%: 1.10–1.43), respectively. Most (57.5%) of the reports
associated with the phosphodiesterase type 5 inhibitors (PDE5Is) were related with concomitant priapism-eliciting drugs taken at
the same time and/or inappropriate intake/excessive dosage. Patients taking trazodone and/or antipsychotics need to be aware of
the priapism-risk; awareness among prescribers would help in reducing priapism-related detrimental sequelae; PDE5I-intake is not
responsible for priapism by itself, when appropriate medical supervision is provided.
IJIR: Your Sexual Medicine Journal; https://doi.org/10.1038/s41443-022-00583-3
INTRODUCTION
Priapism is a pathological condition defined as an erection lasting
longer than 4 h that persists beyond, or is unrelated, to sexual
interest or stimulation [1,2]. Whilst non-ischaemic priapism is rare
and is usually secondary to perineal trauma [3], ischaemic
priapism is indeed the more common subtype, resulting from
decreased venous outflow with venous stasis in the corpora
cavernosa of the penis [1]. It remains a serious urological
emergency which, if left untreated, could lead to hypoxia-
related destruction of the sinusoidal endothelium and corporal
fibrosis, with eventual permanent erectile dysfunction [1]. Timely
management of this emergency is paramount, as extensive
cavernosal-tissue necrosis is a highly likely event occurring after
48 h of priapism [4]. Treatment of ischaemic priapism cases
depends on the episode-duration, ranging from corporal aspira-
tion/irrigation, intra-cavernosal injection of sympathomimetics,
proximal vs. distal shunting procedures, and/or prompt insertion
of a malleable penile prosthesis when extensive and irreversible
hypoxic damage has occurred [2,4]. The incidence of this
condition is believed to be 1.5 cases per 100,000 person-years
[5], although one could expect levels of under-reporting, due to
patients’embarrassment or after spontaneous resolution without
intervention. A predisposition to transient and self-limiting
recurrent episodes of priapism (e.g. “stuttering priapism”) shares
its aetiology with ischaemic priapism and frequently progresses to
a complete form [1]. Although idiopathic episodes of priapism are
common, pharmacologically-induced priapism is now considered
the predominant aetiology [6]. In fact, priapism has been related
to a number of commonly prescribed medications, as well as
illegal drugs [1]. The growing use of a range of prescription
medications such as antidepressants, antipsychotics and intra-
cavernosal injections, and the increase in the abusing levels of
recreational drugs such as cocaine, alcohol, cannabinoids and
amphetamines [7,8], is expected to lead to an increase of
pharmacologically-induced priapism cases. Pharmacologically-
induced priapism is invariably associated with ischaemic features
[1], thus it may determine the above mentioned permanent
detrimental outcomes for the penile function. Hence, it is desirable
that the clinicians involved in the prescription of these index
medications are well aware of their potential to cause ischaemic
priapism, although it is more likely to occur among individuals
with certain susceptibility features [1,2].
Received: 24 October 2021 Revised: 25 April 2022 Accepted: 3 May 2022
1
Università Vita-Salute San Raffaele, Milan, Italy.
2
Division of Experimental Oncology/Unit of Urology, URI; IRCCS Ospedale San Raffaele, Milan, Italy.
3
ASST Sette Laghi—Circolo e
Fondazione Macchi Hospital, Varese, Italy.
4
Department of Urology, IRCCS Foundation Ca’Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
5
Institute of
Andrology, Department of Urology, University College London Hospitals NHS Trust, London, UK.
6
Division of Surgery and Interventional Science, UCL, London, UK.
7
Psychopharmacology; Drug Misuse; and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK.
✉email: salonia.andrea@hsr.it
www.nature.com/ijir
IJIR: Your Sexual Medicine Journal
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... Ischemic (veno-occlusive, low-flow) priapism is associated with a decrease in venous return. In humans, ischemic priapism accounts for 95% of cases [27,28]; the majority of cases are idiopathic [28]; some cases are associated with medications [29]. Usually, the penis is rigid and very painful. ...
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Article
Full-text available
  • Sep 2022
A 5-year-old recently castrated male Doberman dog presented for prolonged erection of one week’s duration with associated pain and dysuria. This was the fourth episode within a year. Each episode was associated with an unusual event, which was stressful for the dog. Castration performed two months prior to the final episode did not prevent recurrence. Due to tissue necrosis, penile amputation and urethrostomy had to be performed. The dog recovered fully. Prolonged erection that persists beyond or that is unrelated to sexual stimulation is called “priapism”. This term refers to the Greek god Priapus, a god of fertility, memorialized in sculptures for his giant phallus. In humans, depending on the mechanism involved, priapism is classified as nonischemic or ischemic. Because prognosis and treatment are different, priapism must be determined to be nonischemic or ischemic. Nonischemic priapism is a rare condition observed when an increase in penile arterial blood flow overwhelms the capacity of venous drainage; it is often associated with penile trauma, and does not require medical intervention. Ischemic priapism is associated with decreased venous return. In humans, ischemic priapism accounts for 95% of cases, the majority of which are idiopathic. Ischemic priapism is a urological emergency; simple conservative measures such as aspiration of blood from the corpora cavernosa and intracavernosal injection of an adrenergic agent are often successful. Stuttering priapism, also called recurrent or intermittent priapism, is a particular form of ischemic priapism reported in humans that is characterized by repetitive episodes of prolonged erections. Management consists of treating each new episode as an episode of acute ischemic priapism, and preventing recurrence with oral medications such as dutasteride and/or baclofen, gabapentin, or tadalafil. To the authors’ knowledge, this case is the first report of stuttering priapism in a dog.
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Adverse reactions of PDE5 inhibitors: An analysis of the World Health Organization pharmacovigilance database
Article
  • Mar 2023
Background: Despite their efficacy and general safety, rare but devastating adverse drug reactions (ADR) have been associated with phosphodiesterase type 5 inhibitors (PDE5is). Objectives: To determine the safety profile of oral PDE5is with a particular focus on priapism and malignant melanoma. Materials and methods: In this case-non-case study, we queried the individual case safety reports (ICSR) for PDE5is within the World Health Organization global database of ICSRs (VigiBase) between 1983 to 2021. We included all ICSRs for sildenafil, tadalafil, vardenafil, and avanafil in men. For comparison, we also extracted the safety data from the Food and Drug Administration (FDA) trials for these drugs. We assessed the safety profile of PDE5is by disproportionality analysis through measuring reporting odds ratio (ROR) for their most commonly reported ADRs, once for all PDE5i reports and once for reports of oral PDE5i use in adult men (≥18 years old) with sexual dysfunction. Results: A total of 94,713 ICSRs for PDE5is were extracted. 31,827 ICRS were identified relating to adult men taking oral sildenafil, tadalafil, vardenafil, or avanafil for sexual dysfunction. The most common ADRs included poor drug efficacy (42.5%), headache (10.4% vs. 8.5-27.6% [FDA]), abnormal vision (8.4% vs. ≤4.6 [FDA]), flushing (5.2% vs. 5.1-16.5% [FDA]), and dyspepsia (4.2% vs. 3.4-11.1% [FDA]). Priapism showed significant signals for sildenafil (ROR = 13.81, 95% CI: 11.75-16.24), tadalafil (ROR = 14.54, 95% CI: 11.56-18.06) and vardenafil (ROR = 14.12, 95% CI: 8.36-22.35). Compared to other medications in VigiBase, sildenafil (ROR = 8.73, 95% CI: 7.63-9.99) and tadalafil (ROR = 4.25, 95% CI: 3.19-5.55) had significantly higher RORs for malignant melanoma. Conclusion: PDE5is show significant signals correlating with priapism among a large international cohort. Further clinical study is needed to elucidate whether this is from proper or inappropriate use or other confounding conditions, as analysis of pharmacovigilance data does not allow for quantifying the clinical risk. Also, there appears to be a relationship between PDE5i use and malignant melanoma which warrants additional study to better understand causation. This article is protected by copyright. All rights reserved.
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Medication-associated priapism events: validation of findings from the FDA pharmacovigilance database using insurance claim database
Article
Pharmacovigilance databases are important for tracking rare adverse events associated with medications. Approximately 51 new drugs are approved each year by the United States Federal Drug Agency and rare adverse events may be too infrequent to be detected in pre-approval clinical trials, thus the importance of these ongoing pharmacovigilance databases. Using the Federal Drug Agency pharmacovigilance databases, Schifano et al. found trazadone, olanzapine, and tadalafil had a higher risk of causing priapism compared to other medications within this database. We attempted to validate these findings using a large US claims database to assess the frequency of priapism diagnosis within 6 months of prescribing medications identified by Schifano et al. (trazodone, quetiapine, risperidone, olanzapine, aripiprazole, tadalafil, sertraline, sildenafil, methylphenidate, alprostadil, and clozapine). On propensity-matched retrospective cohort analysis with 3.4 million men exposed to the drugs of interest with 3.4 million propensity-matched controls. We find that trazadone and tadalafil were associated with increased risk of priapism – risk ratio [RR] 1.73, 95% Confidence Interval [CI] 1.28–2.34 and (RR: 3.00, 95% CI 2.19–4.11), respectively. Sildenafil was also found to be associated with increased risk of priapism diagnosis (RR: 1.77, 95% CI 1.37–2.29). The antipsychotic quetiapine, a second-generation antipsychotic like olanzapine, had the greatest association with a diagnosis of priapism (RR 3.50, 95% CI 1.93–6.34). Some analyses were unable to be performed, such as for alprostadil and olanzapine, as low number of patients having received a prescription for these medications resulted in a propensity-matched control group that was too small to accurately assess the risk ratio for the incidence of priapism. We confirm the findings of Schifano et al. describing the increased risk of priapism associated with prescriptions of trazadone, tadalafil, sildenafil, and second-generation antipsychotics.
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Pretreatment screening and counseling on prolonged erections for patients prescribed trazodone
Article
Full-text available
  • Jan 2021
Purpose: We examined whether patients are appropriately screened for previous prolonged erections or priapism and counseled about trazodone complications, specifically prolonged erections and priapism, prior to trazodone treatment. Materials and methods: We identified patients under the age of 50 on trazodone as of February 27, 2019 at the VA New Jersey Health Care System. Patients were asked about information provided to them prior to medication initiation, occurrence of prolonged erections/priapism, and reporting rate of side effects. Results: Two hundred and twenty nine out of five hundred and twenty four male patients agreed to participate in the study. Forty three out of two hundred and twenty nine of patients were informed about the side effects of prolonged erections and 37/229 of patients were informed of risk of priapism prior to treatment. Only 17/229 of patients were asked if they had had any episodes of prolonged erection or priapism in the past. Eighteen patients developed prolonged erection while taking trazodone. Only 5/18 patients who had developed prolonged erections informed their physicians. Conclusions: Only a fraction of patients were properly screened for previous prolonged erections or priapism and properly informed about the side effects of trazodone. Urologist should better educate trazodone prescribers, such as family medicine and psychiatric colleagues, regarding the side effects of trazodone. It is imperative that prescribing physicians appropriately screen and educate patients prior to trazodone initiation and instruct patients to report any treatment side effects to avoid potential long-term adverse outcomes.
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Interventional radiology management of high flow priapism: review of the literature
Article
Full-text available
  • Sep 2020
Introduction: High-flow priapism is a persistent partial penile tumescence, related to high flow arterial blood into the corpora. In the treatment of high flow priapism, super-selective embolization is considered treatment of choice when conservative treatment fails as reported in the "EAU Guidelines on Priapism", but there are only few series reporting the outcome, the efficacy of different embolic materials and these studies are uncontrolled and relatively small. Objectives: The aim of this study is to review the literature to outline the state of the art of this interventional treatment and to analyse the outcome of the different embolic agents. Methods: Through Medline database we searched all the English-language published articles related to priapism. Keywords were chosen according to MeSH terms. We selected case-series from 1990 to 2020 including at least five cases of high-flow priapism.The variables extracted from the selected articles were: number of patients, mean age, diagnostic imaging modality, mono or bilateral involvement of the arteries, embolization material, technical success, clinical success, complications, recurrence rate and type of reintervention, mean follow up, onset of erectile dysfunction. Results: We analyzed 11 papers.A total of 117 patients, mean age of 30 years, were studied during a period of 8 to 72 months. Technical success average was 99%, varying from 93 to 100%. Clinical success average was 88%, varying from 56 to 100%. After two or more treatments, resolution of priapism was obtained in all patients. No major adverse events registered. Recurrence rate of 21%(25/117) was observed, and only 4 pts underwent surgery. A total of 17 pts (15%) developed erectile dysfunction (ED). Conclusion: Our data suggested comparable outcomes using different types of materials.In line with the last evidences we suggest that the choice of the embolic material should be selected basing on the expertise of the operator, the characteristic of the fistula and characteristic of the patients.
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Is medicinal ketamine associated with urinary dysfunction issues? Assessment of both the European Medicines Agency (EMA) and the UK Yellow Card Scheme pharmacovigilance database-related reports
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Objective: A range of ketamine-induced uropathy (KIU) issues have been typically described in ketamine misusers. Conversely, more knowledge is needed in terms of medicinal ketamine-related urological disturbances, since ketamine prescribing is being increasingly considered for a range of medical and psychopathological conditions. Methods: To assess medicinal KIU issues, we aimed at analyzing both the 2005-2017 European Medicines Agency (EMA) and the 2006-2018 UK Yellow Card Scheme (YCS) pharmacovigilance databases. Results: A total number (eg, all categories) of 11 632 EMA ketamine-related adverse drug reaction (ADR) reports were here identified. Out of these, some 9971 ADRs (eg, 85.7% of the total) were judged as "suspect" and were here analyzed. Some 1758 ADRs (17.7% of 9971, corresponding to 194 individual patients) referred to urological issues, relating to either kidney/ureter (922 ADRs) or bladder/urethra (837 ADRs). Ketamine was the sole drug administered in 156/194 (80.4%) cases/patients. Although most cases occurred in the 1 month-1 year time frame following the start of ketamine prescribing, in 30 cases the ADR occurred within 48 hours. Most ADR-related cases resolved, although both sequelae (18 cases) and fatalities (79/1758; 4.5%) were recorded. Overall, YCS data were consistent with EMA findings, with some 50/217 (23%) ADRs referring to renal/urinary disorders. Conclusions: Current data may only represent a gross underestimate of the KIU real prevalence issues. It is here suggested that chronic treatment involving higher doses/repeated exposure to ketamine be restricted to the context of controlled trials or clinical audits.
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European Association of Urology Guidelines on Sexual and Reproductive Health—2021 Update: Male Sexual Dysfunction
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Context: The present summary of the European Association of Urology (EAU) guidelines is based on the latest guidelines on male sexual health published in March 2021, with a last comprehensive update in January 2021. Objective: To present a summary of the 2021 version of the EAU guidelines on sexual and reproductive health. Evidence acquisition: A literature review was performed up to January 2021. The guidelines were updated, and a strength rating for each recommendation was included based on either a systematic review of the evidence or a consensus opinion from the expert panel. Evidence synthesis: Late-onset hypogonadism is a clinical condition in the ageing male combining low levels of circulating testosterone and specific symptoms associated with impaired hormone production and/or action. A comprehensive diagnostic and therapeutic work-up, along with screening recommendations and contraindications, is provided. Erectile dysfunction (ED) is the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance. Along with a detailed basic and advanced diagnostic approach, a novel decision-making algorithm for treating ED in order to better tailor therapy to individual patients is provided. The EAU guidelines have adopted the definition of premature ejaculation (PE), which has been developed by the International Society for Sexual Medicine. After the subtype of PE has been defined, patient's expectations should be discussed thoroughly and pharmacotherapy must be considered as the first-line treatment for patients with lifelong PE, whereas treating the underlying cause must be the initial goal for patients with acquired PE. Haemospermia is defined as the appearance of blood in the ejaculate. Several reasons of haemospermia have been acknowledged; the primary goal over the management work-up is to exclude malignant conditions and treat any other underlying cause. Conclusions: The 2021 guidelines on sexual and reproductive health summarise the most recent findings, and advise in terms of diagnosis and treatment of male hypogonadism and sexual dysfunction for their use in clinical practice. These guidelines reflect the multidisciplinary nature of their management. Patient summary: Updated European Association of Urology guidelines on sexual and reproductive health are presented, addressing the diagnosis and treatment of the most prevalent conditions in men. Patients must be fully informed of all relevant diagnostic and therapeutic options and, together with their treating physicians, decide on optimal personalised management strategies.
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Review of Priapism Litigation in the United States
Article
Objectives To review medical malpractice trends and to identify the most common claims filed against medical providers for the management of patients with priapism. Methods Using the Westlaw legal database, a search was done for the keyword “priapism” between July 1, 1980 and July 1, 2020. Cases were evaluated for plaintiff demographics, reasons for filing claims, management outcomes, legal verdicts and awards and further categorized based upon the timing of the alleged malpractice. Results Alleged negligence during the pre-management period was cited in 30 cases. Administration of psychotropic medications was the most common reasons for filing pre-management claims 22/56 (39.3%). Delay in care accounted for 18/56 (32.1%) and complications of surgery were 5/56 (8.9%) of claims. The majority of the completed cases were in favor of the defendants (39/47; 83.0%). There was no association between type of health care provider or timing of alleged malpractice and ultimate verdict. Conclusions Prescribing psychoactive medications without warning of the adverse effect profile is the most common reason for claims filed against providers with trazodone as the leading medication. Medical providers should ensure that patients are well informed of this adverse effect prior to prescription. Regardless, the majority of medical malpractice cases carry a verdict in favor of the defendant.
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Patient Education Is Associated With Reduced Delay to Presentation for Management of Ischemic Priapism: A Retrospective Review of 123 Men
Article
  • Jan 2021
Background Adverse outcomes secondary to ischemic priapism (IP) are associated with time to presentation and management. Aim To characterize patterns in presentation delay as a function of etiology and patient education regarding IP risk. Methods Following institutional review board approval, charts of IP patients presenting to our institution from 2010 to 2020 were reviewed. One episode of IP per patient was included for analysis. Outcomes Priapism duration in patients presenting with IP. Results We identified 123 unique patients with IP. Common etiologies included erectogenic intracavernosal injection (24%), trazodone (16%), and other psychiatric medications (16%). Patients with sickle cell anemia or trait and intracavernosal injection–related IP presented sooner than idiopathic cases and those from psychiatric medication (P < .001). Etiology and provider education on IP risk were associated with presentation ≥ 24 hours. Upon multivariate analysis, only a lack of provider education was independently associated with presentation ≥ 24 hours. Clinical Implications Men who received provider-based education on the risk of IP associated with their condition or medication regimen were more likely to seek prompt medical attention for IP and, therefore, less likely to require surgery. Strengths & Limitations This manuscript represents one of the largest series on priapism, an area of urologic practice in need of more evidence-based guidance. The numbers are not inflated by including multiple episodes per patient, and the data collected include etiology, time to presentation, and treatment. Limitations include a retrospective chart review study design at a single institution. Conclusion Educational initiatives on the risk of IP associated with particular disease states and medications should target at-risk individuals, as well as prescribers of medications associated with IP. R Dutta1, EL Matz1, TL Overholt, et al. Patient Education Is Associated With Reduced Delay to Presentation for Management of Ischemic Priapism: A Retrospective Review of 123 Men. J Sex Med 2020;XX:XXX–XXX.
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A Review of Antipsychotics and Priapism
Article
  • Nov 2020
Introduction Pharmacologically induced priapism is now the most common cause of priapism, with approximately 50% of drug-related priapism being attributed to antipsychotic usage. The majority of pharmacologic priapism is believed to result in ischemic priapism (low flow), which may lead to irreversible complications, such as erectile dysfunction. It is imperative that prescribing physicians be aware of potentially inciting medications. Objectives To identify medications, specifically antipsychotics, associated with priapism and prolonged erections and understand the rates and treatment of these side effects. Methods A PubMed search of all articles available on the database relating to priapism, prolonged erections, and antipsychotics was performed. Results Various typical and atypical antipsychotic drugs (APDs) have been implicated in pharmacologically induced priapism. In addition to dopaminergic and serotoninergic receptors, APDs have affinities for a wide array of other receptors in the central nervous system, including histaminergic, noradrenergic, and cholinergic receptors. Although the exact mechanism is unknown, the most commonly proposed mechanism of priapism associated with APDs is α-adrenergic blockade in the corpora cavernosa of the penis. Priapism appears in only a small fraction of men using medications with α1-receptor–blocking properties, indicating differential sensitivities to the α-blocking effect among men, and/or additional risk factors that may contribute to the development of priapism. The best predictor for the subsequent development of priapism is a past history of having prolonged and painless erections. The acute management algorithm of APD-induced priapism is the same as for other causes of low-flow priapism. Conclusion Clinicians should educate patients treated with antipsychotics about the potential for priapism and its sequelae including permanent erectile dysfunction. Appropriate patient education will raise awareness, encourage early reporting, and help reduce the long-term consequences associated with priapism through early intervention. Hwang T, Shah T, Sadeghi-Nejad H. A Review of Antipsychotics and Priapism. Sex Med Rev 2020;XX:XXX–XXX.
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Are We Overstating the Risk of Priapism With Oral Phosphodiesterase Type 5 Inhibitors?
Article
  • Jul 2020
Background Priapism is an adverse drug reaction (ADR) associated with phosphodiesterase type 5 inhibitors (PDE5is) in the treatment of erectile dysfunction. Aim The purpose of this study was to identify the true data about PDE5i-associated priapism to properly counsel patients. Methods We queried the U.S. Food and Drug Administration (FDA) Adverse Reporting System Public Dashboard to identify cases of drug-induced priapism among medications commonly associated with priapism. Next, a systematic review and analysis of publications describing cases of drug-induced priapism were carried out. Outcomes The main outome of this study is incidence of PDE5i-induced priapism. Results We found 411 cases of drug-induced priapism secondary to Viagra, Cialis, or Levitra reported to the Food and Drug Administration since 1998. Compared with PDE5is, drug-induced priapism was 2.6 (n = 1,065) and 2.0 times (n = 817) more commonly reported for second-generation antipsychotics and the antidepressant/sleep aid trazodone, respectively. A total of 240 manuscripts describing cases of drug-induced priapism in patients with non-sickle cell disease were identified. PDE5i-induced priapism accounted for only 2.9% (n = 7) of drug-induced priapism cases. Second-generation antipsychotics (33.8%), a group of “other” medications (11.3%), and alpha-adrenergic antagonists (8.8%) accounted for the greatest percentage of published drug-induced priapism cases. Clinical Implications Extensive counseling about priapism as an ADR for PDE5i for the routine treatment of erectile dysfunction is likely unnecessary. Strengths & Limitations The study used national-level data to identify drug-induced priapism cases. Reported and published cases of drug-induced priapism may reflect more severe and atypical cases of this ADR, which may have underestimated our results. Conclusion PDE5i-induced priapism is a rare event. Drug-induced priapism should be attributed to a wider spectrum of medications that can cause this condition. Rezaee ME, Gross MS. Are We Overstating the Risk of Priapism With Oral Phosphodiesterase Type 5 Inhibitors? J Sex Med 2020;XX:XXX–XXX.
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Priapism from Recreational Intracavernosal Injections in a High-Risk Metropolitan Community
Article
  • Sep 2019
Introduction: Recreational use of intracavernosal injections (ICIs) is a high-risk behavior that involves sharing of these agents by men without physician regulation. Aim: To characterize the etiologies and outcomes of priapism at a Los Angeles metropolitan medical center to better understand patterns of usage of recreational ICIs and the public health implications of such practices. Methods: With institutional review board approval, we retrospectively reviewed all cases of priapism presenting to the emergency room of a Los Angeles tertiary medical center from 2010 to 2018. We compared outcomes between patients who presented with priapism after recreational ICI and patients who presented with other etiologies. Main outcome measure: We describe patient characteristics, etiologies, and treatments of priapism at our institution. Results: We identified 169 priapism encounters by 143 unique patients. Recreational ICIs accounted for 82 of the 169 priapism encounters (49%). Patients who used recreational injections were younger than those who presented with other etiologies (43.5 years vs 47.5 years; P = .048) and had delayed presentations (median, 12 hours vs 8 hours; P < .0001). There was no statistical difference across groups in the proportion of patients requiring operative intervention (14.6% of recreational ICI users vs 16.1% of all other patients; P = .23). A total of 36 out of 72 patients who used recreational ICIs (50%) were HIV+. Clinical implications: Our study adds to the relatively sparse literature on priapism outcomes. We identify and describe a high-risk population that uses recreational intracavernosal injections. Strengths & limitations: To our knowledge, this is the largest series of priapism encounters. However, the data are retrospective from a single institution, and there is a lack of long-term follow up. Conclusion: A large proportion of priapism visits at our institution were attributed to recreational use of ICIs. This is a high-risk patient population that may not be aware of the risks of recreational ICIs and the consequences of priapism. Further effort should be made to increase public and physician awareness of this harmful practice. Zhao H, Berdahl C, Bresee C, et al. Priapism from Recreational Intracavernosal Injections in a High-Risk Metropolitan Community. J Sex Med 2019;16:1650-1654.
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