Respiratory Failure Leading to Intubation in the Setting of Flibanserin Ingestion in a Toddler.

The Psychiatric Consultation Service at Massachusetts General Hospital sees medical and surgical inpatients with comorbid psychiatric symptoms and conditions. During their twice-weekly rounds, Dr Stern and other members of the Consultation Service discuss diagnosis and management of hospitalized patients with complex medical or surgical problems who also demonstrate psychiatric symptoms or conditions. These discussions have given rise to rounds reports that will prove useful for clinicians practicing at the interface of medicine and psychiatry.

Time for a makeover-cosmetics regulation in the United States.

INTRODUCTION: Cosmetics and personal care products are ubiquitous. Consumer pressure arising from recent episodes of products found to be unsafe has led to new policy proposals to modernize cosmetics regulation in the United States. METHODS: We reviewed contemporary cosmetics regulation and collected major past and current policy proposals relating to cosmetics regulation with a focus on public health controversies. RESULTS: Under a structure originally established in 1938 that places regulation of cosmetics under the Food and Drug Administration (FDA), cosmetics manufacturers in the United States are not required to register their products or forward consumer complaints to the FDA, leading to broad under-reporting of adverse events. The FDA has limited authority to mandate product recalls. The existing FDA database system that collects adverse events related to cosmetics has limited public health utility. Current proposals for new cosmetics regulations seek to establish better systems for data collection and mandatory manufacturer registrations funded by cosmetic manufacturers. Additional policy changes could include a premarket review process for cosmeceuticals (cosmetics that make drug-like claims) and more advanced real-world data safety monitoring tools. CONCLUSIONS: With continued consumer concern and several recent cosmetic-related public health controversies, the FDA should be given more resources and broader authority to protect consumer safety.

Skeletal Survey Yield in Young Children with Femur Fractures.

BACKGROUND: Fractures are common in children, and it can be difficult to distinguish unintentional injuries from child abuse. OBJECTIVE: We describe circumstances of injury, prevalence of suspicion for physical abuse, and use of imaging to identify additional occult fractures in young children with femur fractures. METHODS: We reviewed the medical records for children younger than 48 months old with femur fractures treated at a pediatric referral hospital (2011-2013). We abstracted age, ambulation, injury circumstances, bruising, head trauma, additional fractures, and determination of injury suspicious for abuse. RESULTS: In 22 of 127 (17%) children with femur fractures, there was strong suspicion for physical abuse. Infants ≤ 12 months old accounted for 19 of 22 (86%) of those with suspicious injuries. In 2 of 22 (9%) with suspected abuse, the child could walk independently. In 8 of 22 (36%) with suspicious injuries, an injury event was reported as directly witnessed versus 50 of 105 (48%) of the unintentional injuries. Six of 22 (27%) with suspicious injuries had bruises versus 11 of 105 (10%) with unintentional injuries (χ2, p < 0.03). Four of 22 (18%) children with suspicious injuries had head trauma, versus 0 of 105 with unintentional injuries. Of the 8 with occult fractures identified on a skeletal survey (designated suspicious for abuse), all were ≤ 12 months old and none were walking independently. CONCLUSIONS: Most children with femur fractures suspicious for abuse were ≤ 12 months old and not walking independently. Skeletal surveys identified additional fractures in 7% of children, and were useful in the forensic evaluation of non-ambulatory children ≤ 12 months old.

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants.

BACKGROUND/OBJECTIVES: Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer-submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived. METHODS: We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration-designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends. RESULTS: Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit. CONCLUSION: Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health.

Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration.

There have been numerous controversies surrounding cosmetic products and increased cancer risk. Such controversies include associations between parabens and breast cancer, hair dyes and hematologic malignancies, and talc powders and ovarian cancer. Despite the prominent media coverage and numerous scientific investigations, the majority of these associations currently lack conclusive evidence. In 2016, the US Food and Drug Administration (FDA) made publically available all adverse event reports in Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS), which includes complaints related to cosmetic products. We mined CAERS for cancer-related reports attributed to cosmetics. Between 2004 and 2017, cancer-related reports caused by cosmetics represented 41% of all adverse events related to cosmetics. This yielded 4427 individual reports of cancer related to a cosmetic product. Of these reports, the FDA redacted the specific product names in 95% of cancer-related reports under the Freedom of Information Act exemptions, most likely due to ongoing legal proceedings. For redacted reports, ovarian cancer reports dominated (n = 3992, 90%), followed by mesothelioma (n = 92, 2%) and malignant neoplasm unspecified (n = 46, 1%). For nonredacted reports, or those reports whose product names were not withheld (n = 218), 70% were related to ovarian cancer attributed to talc powders, followed by skin cancer (11%) and breast cancer (5%) attributed to topical moisturizers. Currently, CAERS is of limited utility, with the available data having been subjected to significant reporter bias and a lack of supportive information such as demographic data, medical history, or concomitant product use. Although the system has promise for safeguarding public health, the future utility of the database requires broader reporting participation and more complete reporting, paired with parallel investments in regulatory science and improved molecular methods.

Ondansetron does not prevent physical dependence in patients taking opioid medications chronically for pain control.

OBJECTIVES: In this study, we investigated the co-administration of ondansetron with morphine, and whether it could prevent the development of physical dependence in patients taking opioids for the treatment of chronic pain. METHODS: A total of 48 chronic back pain patients (N = 48) participated in this double-blinded, placebo-controlled, randomized study. Patients were titrated onto sustained-release oral morphine and randomized to take 8 mg ondansetron or placebo three times daily concurrently with morphine during the 30-day titration. Following titration, patients underwent Naloxone induced opioid withdrawal. Opioid withdrawal signs and symptoms were then assessed by a blinded research assistant (objective opioid withdrawal score: OOWS) and by the research participant (subjective opioid withdrawal score: SOWS). RESULTS: We observed clinically significant signs of naloxone-precipitated opioid withdrawal in all participants (ΔOOWS = 4.3 ±â€¯2.4, p < 0.0001; ΔSOWS = 14.1 ±â€¯11.7, p < 0.0001), however no significant differences in withdrawal scores were detected between treatment groups. CONCLUSION: We hypothesized that ondansetron would prevent the development of physical dependence in human subjects when co-administered with opioids, but found no difference in naloxone-precipitated opioid withdrawal scores between ondansetron and placebo treatment groups. These results suggest that further studies are needed to determine if 5HT3 receptor antagonists are useful in preventing opioid physical dependence.

Ondansetron Does Not Reduce Withdrawal in Patients With Physical Dependence on Chronic Opioid Therapy.

OBJECTIVES: Individuals taking opioids for an extended period of time may become physically dependent, and will therefore experience opioid withdrawal should they stop taking the medication. Previous work in animal and human models has shown that the serotonin (5-HT3) receptor may be implicated in opioid withdrawal. In this study, we investigated if ondansetron, a 5-HT3-receptor antagonist, could reduce the symptoms of opioid withdrawal after chronic opioid exposure in humans. METHODS: In this double-blinded, randomized, crossover study, 33 chronic back pain patients (N = 33) were titrated onto sustained-release oral morphine for 30 days. After titration, participants attended 2 study sessions, 1 week apart, in which opioid withdrawal was induced with intravenous naloxone, with or without 8 mg intravenous ondansetron pretreatment. Opioid withdrawal symptoms were assessed by a blinded research assistant (objective opioid withdrawal score [OOWS]) and by the research participant (subjective opioid withdrawal score [SOWS]). RESULTS: Clinically significant signs of withdrawal were observed during both the ondansetron (ΔOOWS = 3.58 ±â€Š2.22, P < 0.0001; ΔSOWS = 12.48 ±â€Š11.18, P < 0.0001) and placebo sessions (ΔOOWS = 3.55 ±â€Š2.39, P < 0.0001; ΔSOWS = 12.21 ±â€Š10.72, P < 0.0001), but no significant differences were seen between the treatment sessions in either the OOWS or SOWS scores. CONCLUSION: We hypothesized that ondansetron would reduce opioid withdrawal symptoms in human subjects, but found no difference in withdrawal severity between ondansetron and placebo sessions. These findings suggest that more investigation may be necessary to determine if 5-HT3-receptor antagonists are suitable treatment options for opioid withdrawal.

An observational study of adults seeking emergency care in Cambodia.

OBJECTIVE: To describe the characteristics and chief complaints of adults seeking emergency care at two Cambodian provincial referral hospitals. METHODS: Adults aged 18 years or older who presented without an appointment at two public referral hospitals were enrolled in an observational study. Clinical and demographic data were collected and factors associated with hospital admission were identified. Patients were followed up 48 hours and 14 days after presentation. FINDINGS: In total, 1295 hospital presentations were documented. We were able to follow up 85% (1098) of patients at 48 hours and 77% (993) at 14 days. The patients' mean age was 42 years and 64% (823) were females. Most arrived by motorbike (722) or taxi or tuk-tuk (312). Most common chief complaints were abdominal pain (36%; 468), respiratory problems (15%; 196) and headache (13%; 174). Of the 1050 patients with recorded vital signs, 280 had abnormal values, excluding temperature, on arrival. Performed diagnostic tests were recorded for 539 patients: 1.2% (15) of patients had electrocardiography and 14% (175) had diagnostic imaging. Subsequently, 783 (60%) patients were admitted and 166 of these underwent surgery. Significant predictors of admission included symptom onset within 3 days before presentation, abnormal vital signs and fever. By 14-day follow-up, 3.9% (39/993) of patients had died and 19% (192/993) remained functionally impaired. CONCLUSION: In emergency admissions in two public hospitals in Cambodia, there is high admission-to-death ratio and limited application of diagnostic techniques. We identified ways to improve procedures, including better documentation of vital signs and increased use of diagnostic techniques.