Food And Drug Administration Communication Research Articles

Fifteen-Year Trend in Inferior Vena Cava Filter Utilization before and after U.S. Food and Drug Administration Communications: Data from the National Inpatient Sample 2005–2019

The purpose of this study was to evaluate the contemporary trends in inferior vena cava (IVC) filter utilization in the inpatient setting following the U.S. Food and Drug Administration (FDA) safety communications and compare those trends in relation to incidence of hospital admissions involving venous thromboembolism (VTE). The National Inpatient Sample was queried between 2005 and 2019. There was an increasing trend in the utilization of IVC filters between 2005 and 2010 (P < .01). Following the FDA communication in 2010, this reversed to a decreasing trend (P < .001), which persisted following the second FDA communication in 2014, although there was no significant change in the rate of decline (P = .67). Throughout the study period, the proportion of IVC filters placed in patients with VTE increased from 70.8% to 82.2%.

Slings in the era of the mesh ban: now what?

Use of midurethral slings (MUS) as gold standard for stress urinary incontinence declined after the recent US Food and Drug Administration (FDA) communication. What is the current status in the surgical treatment of stress urinary incontinence? What impact do regular FDA communications and numerous restrictions around the world have? The current literature on surgical treatment of incontinence was evaluated; medical press information and literature regarding the FDA communication were assessed. The legal situation is illustrated using the example of the Montgomery case in England. Despite positive results from literature and gynecological and urological societies, there has been asignificant decline in the use of MUS. The current 2022 German interdisciplinary 2k-guideline for the treatment of female stress urinary incontinence confirms the efficacy and safety of MUS. Analysis of recent literature supports the importance of continued long-term outcome data regarding the safety and efficacy of suburethral slings for treatment of female stress urinary incontinence.

Codeine prescribing practices before and after the 2017 FDA warning at an academic health system

BackgroundIn April of 2017, the U.S. Food and Drug Administration (FDA) issued a boxed warning contraindicating codeine use in all patients younger than 12 years of age. ObjectivesThe purpose of this study was to describe changes in codeine prescribing practices across a broad range of professions and specialties before and after the boxed warning and identify opportunities for optimization of a health system-wide response to changes in evidence-based practice recommendations. MethodsPatients younger than 12 years of age with codeine-containing products prescribed between February 2017 and April 2018 at a single health system were included. Patient demographics, provider specialty, and prescription indication were collected by retrospective chart review. For categorical variables, frequency and percentage were calculated; for continuous variables, means with standard deviations or medians with interquartile ranges were calculated. ResultsCodeine prescriptions for patients younger than 12 years of age declined after the boxed warning issued by the FDA. Some provider specialties reacted promptly whereas others took longer to change their practice. Temporally, the largest decreases in prescribing centered around the month after the FDA communication release in April 2017 and the later implementation of electronic health record (EHR) alerts in June 2017. ConclusionGiven the persistence of codeine prescribing even after EHR soft-stop alerts were implemented, future pharmacy informatic responses to changes in evidence-based practice recommendations could be optimized using hard-stop alerts for high-impact recommendations. Studies comparing combination codeine products and other opioid medications for chronic pain in pediatric patients would be helpful to characterize the true level of risk in this population.

228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk

BackgroundFluoroquinolones were commonly prescribed for hospitalized patients with diabetic foot infection (DFI) at our institution, included in 69% of empiric antibiotic regimens from 2011–2014. On December 20, 2018, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding the risk of aortic aneurysm with fluoroquinolones. The objective of this study was to assess the impact of the FDA Communication on antibiotic prescribing for DFI.MethodsThis was a single-center quasi-experimental study of hospitalized patients initiated on antibiotics for DFI before (February-December 2018) and after (February-December 2019) the 2018 FDA Communication. Patients with concomitant infections or documented beta-lactam or fluoroquinolone allergies were excluded. The primary outcome was inpatient days of fluoroquinolone therapy. Secondary outcomes included days of beta-lactam therapy and Outpatient Parenteral Antibiotic Therapy (OPAT) enrollment. Variables were compared using the Pearson’s chi square, Fisher’s exact, and Mann Whitney U tests, as appropriate. A logistic regression was performed to identify predictors for inpatient receipt of fluoroquinolones.ResultsA total of 198 patients were included. Baseline characteristics were similar between groups (Table 1). After the FDA Communication, the median duration of inpatient fluoroquinolones decreased from 3 [0–5.5] to 0 [0–1] days (p< 0.001). The duration of antipseudomonal beta-lactams increased from 0 [0–2] to 2 [0–6] days (p< 0.001). OPAT enrollment increased from 16.5% to 29.7% (p=0.028), with a corresponding increase in peripherally inserted central catheter placement (15.5% to 25.7%, p=0.074). There was no difference in outpatient fluoroquinolone prescribing over time. Incidence of re-infection, readmission for DFI, and antibiotic adverse events were similar between groups (Table 2).Table 1 Table 2 ConclusionInpatient fluoroquinolone prescribing for DFI decreased significantly following the 2018 FDA Communication, followed by an increase in antipseudomonal beta-lactam use and OPAT enrollment. FDA statements can influence institutional antibiotic prescribing and transitions of care decisions, representing an opportunity for education by Antimicrobial Stewardship programs.Disclosures All Authors: No reported disclosures

Benzodiazepines: Thinking outside the black box

The United States Food and Drug Administration (FDA) recently issued a Drug Safety Communication requiring Boxed Warning updating and other changes in order to improve the safe use of the benzodiazepine drug class. These changes were prompted because 'The current prescribing information for benzodiazepines does not provide adequate warnings about [the] serious risks and harms associated with these medicines so they may be prescribed and used inappropriately'. The FDA Communication points out that benzodiazepines can be an important option for treating disorders for which these drugs are indicated. However, the acknowledged problems of these drugs, which historically were considered an acceptable trade-off against their benefits, need to be reassessed in light of their widespread (over?) prescribing (for example, in 2019 an estimated 92 million benzodiazepine prescriptions were dispensed from US retail and mail-order pharmacies). The FDA Communication can be viewed as an important step in reminding healthcare providers of the 'serious risks and harms associated with these medicines', and validation of such reports by patients. Importantly, the FDA Communication includes an often-neglected aspect of benzodiazepine prescribing, namely how to discontinue use, and the perplexing protracted withdrawal syndrome experienced by some patients. The Communication advises to providers: 'No standard benzodiazepine tapering schedule is suitable for all patients; therefore, create a patient-specific plan to gradually reduce the dosage, and ensure ongoing monitoring and support as needed to avoid serious withdrawal symptoms or worsening of the patient's medical condition'.

Rates of Sling Procedures and Revisions-A National Surgical Quality Improvement Program Database Study.

The aim of this study was to describe trends in sling procedures and revisions, including fascial slings and midurethral slings (MUS) using a large, national database with respect to the 2011 U.S. Food and Drug Administration (FDA) mesh-related safety communication. This was a cross-sectional cohort study using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2010 to 2018, evaluating the prevalence of sling revision and fascial slings and their trends over time. Patients who underwent MUS, fascial slings, and sling revisions were identified by Current Procedural Terminology codes. Sling revisions and fascial slings were evaluated as a proportion of the total number of MUS performed per year. Three distinct periods were evaluated in relation to the 2011 FDA communication: 2010 to 2012, 2012 to 2015, and 2015 to 2018. Observed trends were assessed with Pearson correlation coefficients with a P value less than 0.05 considered significant. During the study period, 32,657 slings were captured: 32,389 MUS and 268 fascial slings. The rate of sling revisions was low (0.4% in 2010 to 1.2% in 2015). Between 2012 and 2015, the rate of sling revision increased significantly (R = 1, P = 0.002); following 2015, the rate of sling revisions decreased significantly over time (R = -0.96, P = 0.04). The rate of fascial slings between 2012 and 2015 increased significantly (R = 0.95, P = 0.047); however, the rate plateaued starting in 2015 (R = -0.49, -P = 0.51). Our data suggest that MUS remain the preferred procedure for treatment of stress urinary incontinence despite the recent FDA communications with MUS representing 99% of sling procedures during the study period.

Occult Uterine Malignancy at the Time of Sacrocolpopexy in the Context of the Safety Communication on Power Morcellation by the FDA

The objective of this study was to determine the incidence of occult uterine malignancy at the time of sacrocolpopexy with concurrent hysterectomy, in the context of practice pattern changes as a result of the 2014 Food and Drug Administration (FDA) power morcellation safety communication. Retrospective chart review. Tertiary care referral center in the United States. A total of 839 patients who underwent sacrocolpopexy from January 2004 to December 2018. All patients received a concurrent hysterectomy without a diagnosis of suspected or confirmed gynecologic malignancy before surgery. Trends of surgeries were compared before and after the 2014 FDA power morcellation safety communication. Demographic and perioperative data were collected from the system-wide electronic medical record. Operative and pathology reports were reviewed to determine the method of specimen retrieval and specimen pathology results. A total of 238 patients (28.4%) had a hysterectomy at the time of sacrocolpopexy. There were no cases of occult uterine malignancy (0%, 95% CI 0%-1.6%). There was 1 case of borderline tumor of the ovary. The most common mode of hysterectomy over the 15-year period was laparoscopic hysterectomy (n = 84, 35.3%), followed by vaginal hysterectomy (n = 63, 26.5%). After the FDA communication, the most common form of hysterectomy changed significantly to vaginal hysterectomy (n = 35, 55.6%; p <.001). When comparing the first 2 years after the announcement (2014-2016) to the subsequent 2 years (2017-2018), there was again a significant increase in the use of laparoscopic hysterectomy in the latter time period (7.3% vs 40.9%; p <.001). In this cohort of patients undergoing sacrocolpopexy with concurrent hysterectomy, the incidence of occult uterine malignancy was low. After the FDA safety communication, practice patterns with regard to the mode of hysterectomy changed, but the magnitude of these changes were transient.

Food and Drug Administration Safety Communication on the Use of Transvaginal Mesh in Pelvic Organ Prolapse Repair Surgery: The Impact of Social Determinants of Health.

This study was to examine the impact of the July 2011 Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh in pelvic organ prolapse (POP) repair by patients' race and ethnicity. We conducted an observational cohort study of women undergoing POP repairs in 2008 to 2015 in New York State. We examined the changes in transvaginal mesh use in POP repairs before and after the FDA communication by patients' race and ethnicity. Piecewise logistic regression models were used to assess the trends of mesh use, adjusting for patient characteristics. We performed a subgroup analysis of the trends of transvaginal mesh use by racial groups, stratifying by patients' neighborhood socioeconomic status. We included 49,848 women (78% white, 7% black, and 15% Hispanic) with an average ± SD age of 60.2 ± 13.0 years. After the safety communication, the use of transvaginal mesh in POP repairs decreased among white women (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.41-0.50) and African Americans (OR, 0.48; 95% CI, 0.35-0.67) but remained stable among Hispanic women (OR, 0.88; 95% CI, 0.70-1.11). Only in the subgroup of patients from high-income areas, there was a trend toward decreasing mesh use among Hispanic patients after 2011 (OR, 0.71; 95% CI, 0.49-1.04). The communications related to the safety of transvaginal mesh did not have an equal impact across racial groups. Mesh use decreased among white and African American women but not among Hispanic women after the 2011 FDA safety communication. Particular attention is warranted for patients from disadvantaged groups, especially low-income minorities, when disseminating medical device safety messages.

Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration.

To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death. The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with "death" listed as a patient event were queried further. There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery. Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.

Racial Disparities in Response to a US Food and Drug Administration Safety Communication Regarding the Use of Power Morcellation for the Treatment of Uterine Leiomyoma

Study ObjectiveTo investigate whether the rate of increase in the performance of abdominal myomectomy over a laparoscopic approach after the US Food and Drug Administration (FDA) safety communication regarding morcellator use for myomectomy differs among races. DesignRetrospective cohort study. SettingThe American College of Surgeons National Surgical Quality Improvement data. PatientsPatients aged 18 to 55 years who underwent either laparoscopic or abdominal myomectomy, excluding malignant cases, emergency cases, operations performed by nongynecologic specialists, and cases in which myomectomy was performed during cesarean section. InterventionsNone. Measurements and Main ResultsThe odds ratios of abdominal myomectomy over laparoscopic myomectomy before and after the release of the FDA communication were calculated in 3 race categories: white, African American, and other races. In a logistic regression analysis adjusted for possible confounders, including all races, the odds ratio of abdominal myomectomy before and after the FDA communication was 1.30 (95% confidence interval [CI], 1.20–1.41; p <.001). In a logistic regression analysis with a product term of FDA communication exposure and race as a possible effect modifier, the African American population showed a significantly greater change in the odds of abdominal myomectomy over laparoscopic myomectomy in comparison with the white population (1.22; 95% CI, 1.02–1.47; p = .03). In contrast, other races showed no significant change (.83; 95% CI, .64–1.08; p = .17). ConclusionAfter the FDA communication, the odds ratio of abdominal myomectomy was disproportionately increased in the African American population.

Public Awareness of Uterine Power Morcellation Through US Food and Drug Administration Communications: Analysis of Google Trends Search Term Patterns.

BackgroundUterine power morcellation, where the uterus is shred into smaller pieces, is a widely used technique for removal of uterine specimens in patients undergoing minimally invasive abdominal hysterectomy or myomectomy. Complications related to power morcellation of uterine specimens led to US Food and Drug Administration (FDA) communications in 2014 ultimately recommending against the use of power morcellation for women undergoing minimally invasive hysterectomy. Subsequently, practitioners drastically decreased the use of morcellation.ObjectiveWe aimed to determine the effect of increased patient awareness on the decrease in use of the morcellator. Google Trends is a public tool that provides data on temporal patterns of search terms, and we correlated this data with the timing of the FDA communication.MethodsWeekly relative search volume (RSV) was obtained from Google Trends using the term “morcellation.” Higher RSV corresponds to increases in weekly search volume. Search volumes were divided into 3 groups: the 2 years prior to the FDA communication, a 1-year period following, and thereafter, with the distribution of the weekly RSV over the 3 periods tested using 1-way analysis of variance. Additionally, we analyzed the total number of websites containing the term “morcellation” over this time.ResultsThe mean RSV prior to the FDA communication was 12.0 (SD 15.8), with the RSV being 60.3 (SD 24.7) in the 1-year after and 19.3 (SD 5.2) thereafter (P<.001). The mean number of webpages containing the term “morcellation” in 2011 was 10,800, rising to 18,800 during 2014 and 36,200 in 2017.ConclusionsGoogle search activity about morcellation of uterine specimens increased significantly after the FDA communications. This trend indicates an increased public awareness regarding morcellation and its complications. More extensive preoperative counseling and alteration of surgical technique and clinician practice may be necessary.

Rate of Pelvic Organ Prolapse Surgery Among Privately Insured Women in the United States, 2010-2013.

To analyze utilization of, and payments for, pelvic organ prolapse procedures after the 2011 U.S. Food and Drug Administration (FDA) communication regarding transvaginal mesh. This is a retrospective cohort study examining private claims from three insurance providers for inpatient and outpatient prolapse procedures from 2010 to 2013 in the Health Care Cost Institute. Primary outcomes were the change in utilization of prolapse procedures, with and without mesh, before and after the July 2011 FDA communication. Secondary outcomes were the changes in payments and reimbursements for these procedures. Utilization rates and payments were compared using generalized linear models and interrupted time-series analysis. Utilization of prolapse procedures decreased from 12.3 to 9.7 per 10,000 woman-years (P=.027) with a decrease of 30.7% (3.9 in 2010 to 2.7 in 2013, P=.05) in number of mesh procedures and 16.6% (8.4 in 2010 to 7.0 in 2013, P=.011) for nonmesh procedures. Quarterly utilization of mesh procedures was increasing before the FDA communication and then significantly declined after its release (slope=0.024 vs -0.025, P=.002). Nonmesh procedures, however, were already slightly decreasing before July 2011 and continued to decline at a more rapid pace after that time, although not significantly (slope=-0.004 vs -0.022, P=.47). Inpatient utilization decreased 52.2% (P=.002), whereas outpatient utilization increased 18.5% (P=.132). Payments for individual inpatient procedures, with and without mesh, increased by 12.0% ($8,315 in 2010 to $9,315 in 2013, P=.001) and 15.6% ($7,826 in 2010 to $9,048 in 2013, P=.005), respectively, whereas those for outpatient procedures increased by 41% ($4,961 in 2010 to $6,981 in 2013, P=.006) and 30% ($3,955 in 2010 to $5,149 in 2013, P=.004), respectively. Use of prolapse surgery declined during the study period. After the 2011 FDA communication regarding transvaginal mesh, there was a significant decrease in the utilization of procedures with mesh but not for those without mesh. A shift toward outpatient surgeries was observed, and payments for both individual inpatient and outpatient cases increased.

Trends in internet search activity, media coverage, and patient-centered health information after the FDA safety communications on surgical mesh for pelvic organ prolapse.

In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information. Google Trends™ was utilized to evaluate search engine trends for the term "pelvic organ prolapse" and associated terms between 1 January 2004 and 31 December 2014. Google News™ was utilized to quantify the number of news articles annually under the term "pelvic organ prolapse." The search results for the term "pelvic organ prolapse" were assessed for quality using the Health On the Net Foundation (HON) certification. There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p = 0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r2 = 0.88, with a coefficient of 186. Quality assessment demonstrated that 42% of websites were HON-certified, with .gov sites providing the highest quality information. Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.

Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey

Study ObjectiveTo assess the impact of the Food and Drug Administration (FDA) warning about power morcellation use on the daily clinical practice of Italian gynecologists. DesignElectronic survey mailed to the main gynecologic centers (Canadian Task Force Classification type III). SettingUnit of Obstetrics and Gynecology, IRCCS - Arcispedale S. Maria Nuova di Reggio Emilia (Italy). PatientsThe study did not include patient data. InterventionThere was no intervention. Measurements and Main ResultsFrom 490 surveys sent out, 426 replies were included in the final analysis (return rate = 86.9%). Four hundred of the 426 (93.9%) gynecologists were aware of the FDA warning. One hundred fifty of 302 (49.7%) of experienced gynecologists and 176 of 349 (50.4%) of oncology gynecologists considered laparoscopy the best approach for myomectomy. The FDA communication was considered overly restrictive by experienced and oncology gynecologists who declared that they had no intention of changing their surgical approach. Two hundred fifty of the 426 (58.7%) gynecologists declared that they would change their surgical approach only to prevent legal litigation. ConclusionThe FDA warning also affected Italian gynecologists. Particularly, less experienced gynecologists and those without oncologic practice seem to be more interested in avoiding legal litigation rather than a real clinical risk of upstaging an unexpected leiomyosarcoma. Fear of undiagnosed sarcoma could increase the number of laparotomies.

Novel Developments in the Pharmacological Management of Insomnia

Advances in the basic science of sleep/wake neurophysiology are driving the exploration of new pharmacologic approaches with continued improvement in efficacy and safety.

Smokers' and Nonsmokers' Beliefs About Harmful Tobacco Constituents: Implications for FDA Communication Efforts

Legislation requires the U.S. Food and Drug Administration (FDA) to release information to the public about harmful constituents in tobacco and tobacco smoke. To inform these efforts, we sought to better understand how smokers and nonsmokers think about tobacco constituents. In October 2012, 300 U.S. adults aged 18-66 years completed a cross-sectional Internet survey. The questions focused on 20 harmful tobacco constituents that the FDA has prioritized for communicating with the public. Most participants had heard of 7 tobacco constituents (ammonia, arsenic, benzene, cadmium, carbon monoxide, formaldehyde, and nicotine), but few participants had heard of the others (e.g., acrolein). Few participants correctly understood that many constituents were naturally present in tobacco. Substances that companies add to cigarette tobacco discouraged people from wanting to smoke more than substances that naturally occur in cigarette smoke (p < .001). Ammonia, arsenic, carbon monoxide, and formaldehyde being in cigarettes elicited the most discouragement from smoking. Constituents elicited greater discouragement from wanting to smoke if respondents were nonsmokers (β = -.34, p < .05), had negative images of smokers (i.e., negative smoker prototypes; β = .19, p < .05), believed constituents are added to tobacco (β = .14, p < .05), or were older (β = .16, p < .05). Our study found low awareness of most tobacco constituents, with greater concern elicited by additives. Efforts to communicate health risks of tobacco constituents should consider focusing on ones that elicited the most discouragement from smoking.

Datapoints: Prevalence of QT Prolongation Among Veterans With Severe Mental Illness

Back to table of contents Previous article Next article ColumnsFull AccessDatapoints: Prevalence of QT Prolongation Among Veterans With Severe Mental IllnessEileen M. Stock, Ph.D., Laurel A. Copeland, Ph.D., M.P.H., Ruth L. Bush, M.D., M.P.H., and John E. Zeber, Ph.D., M.H.A.Eileen M. StockSearch for more papers by this author, Ph.D., Laurel A. CopelandSearch for more papers by this author, Ph.D., M.P.H., Ruth L. BushSearch for more papers by this author, M.D., M.P.H., and John E. ZeberSearch for more papers by this author, Ph.D., M.H.A.Published Online:1 Oct 2013https://doi.org/10.1176/appi.ps.201300212AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail The QT interval refers to the time required for the heart to repolarize after ventricular depolarization. The U.S. Food and Drug Administration (FDA) has issued Drug Safety Communications on drugs associated with QT prolongation and fatal ventricular arrhythmias. Antidepressants received attention after the 2011 FDA communication on citalopram, often prescribed off-label for posttraumatic stress disorder (PTSD).Aggregated data (diagnosis codes and outpatient prescriptions) were examined for all Veterans Health Administration (VHA) patients treated between October 2005 and September 2009. Among 7.1 million patients, 1,224 had a diagnosis of QT prolongation (ICD−9 code 426.82). Chi square tests assessed the association of prior-year severe mental illness with QT prolongation.Among patients with QT prolongation, the mean age was similar to that for all VHA patients (about 61 years). However, rates of severe mental illness were higher (28% versus 12% for all VHA patients). Risk factors for QT prolongation included gender (35 females versus 16 males per 100,000) and African-American race (31 per 100,000 versus 20 for all patients). QT prolongation among patients with severe mental illness was nearly triple that among patients without severe mental illness (40 per 100,000 versus 14), and it was elevated for specific illnesses (Figure 1). Citalopram was prescribed to 8% of the study sample, more commonly for patients with PTSD (16%) or major depression (21%). Receipt of any drug associated with QT prolongation varied by illness: without severe mental illness, 14%; schizophrenia, 20%; PTSD, 24%; and major depression, 28%.Figure 1 Prevalence of QT prolongation among Veterans Health Administration patients, October 2005 to September 2009aa95% confidence intervals reported in parentheses. PTSD, posttraumatic stress disorderFindings highlight the need to reevaluate types and combinations of medications that may potentiate heart disease or death among patients with severe mental illness. A study limitation is that the data precede the 2011–2012 FDA Drug Safety Communications, and citalopram use may change in the wake of the warnings.Except for Dr. Bush, the authors are affiliated with the Center for Applied Health Research, which is jointly sponsored by the Central Texas Veterans Health Care System and Scott & White Healthcare, 2102 Birdcreek Dr., Temple, TX 76502 (e-mail: eileen.[email protected]gov). All authors are affiliated with Texas A&M Health Science Center, Bryan, Texas. Amy M. Kilbourne, Ph.D., M.P.H., and Tami L. Mark, Ph.D., are editors of this column.Acknowledgments and disclosuresThe study was supported by grant IIR-09-335 from VA Health Services Research and Development. The views do not necessarily represent those of the Department of Veterans Affairs.The authors report no competing interests. FiguresReferencesCited byDetailsCited byPsychotropic Pharmacotherapy Associated With QT Prolongation Among Veterans With Posttraumatic Stress Disorder11 April 2018 | Annals of Pharmacotherapy, Vol. 52, No. 9Evaluating the risk of QTc prolongation associated with antidepressant use in older adults: a review of the evidence4 May 2018 | Therapeutic Advances in Drug Safety, Vol. 9, No. 6 Volume 64Issue 10 October 2013Pages 942-942 Metrics Acknowledgments and disclosuresThe study was supported by grant IIR-09-335 from VA Health Services Research and Development. The views do not necessarily represent those of the Department of Veterans Affairs.The authors report no competing interests.PDF download History Published online 1 October 2013 Published in print 1 October 2013

Citalopram’s Adverse Effects Prompt Prescribing Cautions

Citalopram’s Adverse Effects Prompt Prescribing Cautions

Mesh for Anterior Pelvic Organ Prolapse: Where Do We Go Now?

Pelvic organ prolapse (POP) repair using native tissue has a significant risk of failure, especially for anterior compartment repair. Surgical techniques using a variety of mesh grafts and approaches have been developed to decrease the risk of recurrence and improve overall outcomes. Some, but not all, studies have demonstrated that synthetic mesh grafts and mesh kits improve objective outcomes. However, reports of complications with the use of synthetic mesh grafts and mesh kits have been emerging. Such reports have stirred the interests of physicians, medical societies, the media, and regulatory agencies such as the US Food and Drug Administration (FDA), which in July 2011 issued a Safety Communication updating a 2008 statement warning about synthetic mesh and mesh kit complications associated with POP repair. This article discusses current and future directions using synthetic mesh for anterior compartment POP repair in the context of the recent FDA communication.

Warnings Without Guidance

In January 2008, the Food and Drug Administration (FDA) communicated concerns about the efficacy of ezetimibe, but did not provide clear clinical guidance, and substantial media attention ensued. We investigated the proportion of patients who discontinued therapy and switched to a clinically appropriate alternative after the FDA communication. Using claims data from a national pharmacy benefits manager, we created a rolling cohort of new users of ezetimibe between January 2006 and August 2008 and created a supply diary for each patient in the year after cohort entry. A patient was identified as nonpersistent if a gap of 90 days was seen in the diary. Using segmented linear regression, we compared rates of nonpersistence before and after the FDA communication and assessed patient-level characteristics associated with discontinuation. Among nonpersistent patients, we determined whether a patient made a clinically appropriate switch in the subsequent 90 days by adding a new cholesterol-lowering medication or by increasing the dose of an existing one. We used a weighted t test to compare the rates of appropriate switching before and after the communication. Among 867,027 new ezetimibe users, 407,006 (46.9%) were nonpersistent in the first year. After the FDA communication, the monthly level of ezetimibe nonpersistence increased by 5.7 percentage points (P<0.0001). Younger patients, those who lived in low-income zip codes, and female patients were less likely to discontinue therapy (P<0.0001 for all). Among nonpersistent patients, rates of clinically appropriate switching increased from 10.8% before to 16.5% after the FDA warning (P = 0.004). A substantial increase in ezetimibe nonpersistence rates was seen after an FDA communication regarding its efficacy and following associated media attention, and a small proportion of patients made a clinically appropriate switch after discontinuation. Further consideration is needed to deliver messages that promote appropriate use of chronic therapy rather than simply reduce use.