The FDA has set a Prescription Drug User Fee Act target date of April 1, 2019.
Unlike other generic approvals, epinephrine auto-injectors are considered "combination products" because they consist of both a drug and a device, making the approval process more challenging.
The American College of Cardiology and American Heart Association developed updated guidelines on the evaluation, management, and monitoring of adults with congenital heart disease.
For cancers associated with numerous copy number changes, it is difficult to assign disease classifiers and identify useful targets for drug development.
The International Antiviral Society-USA Panel has updated its recommendations for the management and prevention of HIV infection, to reflect the most current data on new treatment regimens and strategies.
In a move that shocked world health officials, the Trump administration indicated its opposition to a resolution intended to encourage breastfeeding among new mothers
Investigators examined the relationship between menstrual cycle characteristics in adolescence and early adulthood and the risk for early natural menopause.
A low-literacy, pain self-management program delivered one-on-one by a health educator or in groups with lectures from experts over a period of 6 months may improve chronic pain outcomes.
A systematic literature review, published in Clinical Infectious Diseases, found no evidence supporting a benefit to antibacterial therapy for osteomyelitis in patients with stage IV sacral pressure ulcers.
There are 14 states that perform a routine second screening in infants at approximately 2 weeks of age.
Close to one-third of sexually active HIV-positive men who have sex with men (MSM) have not received syphilis screening in the past 12 months.
Immunization with Tdap vaccine during pregnancy results in higher levels of antibodies early in infancy but lower levels after the primary vaccine series.
No Impact on Carotid Artery Intima-Media Thickness Following Cessation of Menopausal Hormone Therapy
A follow-up study from KEEPS found that cessation of menopausal hormone therapy did not change the expected trajectory of carotid artery intima-media thickness over a 3-year period.
Does Bipolar I Disorder Effect the Course of Conduct/Antisocial Personality Disorders in Adolescents?
Adolescents with bipolar I disorder whose symptoms are in remission are significantly less likely to experience conduct disorder or antisocial personality disorder.
It is critical for us to remember that children are not little adults. Pediatric-onset diabetes is different from adult-onset diabetes due to its distinct epidemiology, pathophysiology, developmental considerations, and response to therapy.
ROM tests are used to aid in diagnosing ruptured membranes in pregnant women through analysis of vaginal secretions.
High-dose esomeprazole taken in combination with aspirin may safely and effectively improve outcomes in patients with Barrett esophagus.
Results showed an increased risk of bleeding with SRIs by 1.16-2.36 times with an even higher 3.17- to 10.9-fold risk with concomitant NSAIDs.
Children and young adults with asthma and multiple food allergies may be at risk for reduced small airway lung function than children with a single food allergy.
Research shows that patients diagnosed with atopic dermatitis experience feelings of dissatisfaction with regard to lifestyle, as well as impaired health and wellness.
Differences exist in race and gender in patients with chronic lower back pain, especially in pain sensitivity and severity due to aftersensations from mechanical punctuate pain and deep muscle hyperalgesia.
Often central to communities, faith-based organizations serve as local touchstones for health initiatives and outreach programs.
The insulin sensitivity in post- and premenopausal women along with lipid deposition in the liver and skeletal muscle was examined.
A rheumatologist and orthopedic surgeon provide an interdisciplinary perspective on the perioperative management of antirheumatic medications in patients undergoing elective orthopedic surgery.
An expert panel developed suggestions for chronic cough management in interstitial lung disease, but more clinical trials are needed to establish recommendations.
International evidence-based guidelines include 166 recommendations and practice points to improve health outcomes of women with PCOS.
As there is currently no treatment option available to slow the progression of preeclampsia, clinicians assess esomeprazole, a proton pump inhibitor, as a therapeutic candidate for this challenging condition.
Investigators compared low-carbohydrate with low-fat diet on glucose control and other metabolic and anthropometric variables in T2D.
Sensitization to Aspergillus fumigatus increased the risk for severe asthma.
In high-volume centers, patients with liver metastases from colorectal cancer may often be eligible for minimally invasive liver surgery via laparoscopy, thereby reducing potential morbidity risks associated with open surgery.
The Belmont Report provides an appropriate framework for living donor organ transplantation.
Hand, foot, and mouth disease is a mild viral infection common in children. Here are 10 things your patients need to know about this ailment.
For adolescents and young adults, the co-administration of quadrivalent meningococcal conjugate vaccine with incorporated tetanus toxoid with diphtheria-tetanus-acellular pertussis vaccine is noninferior to isolated vaccination and does not compromise immunity.
There is no distinct cut off for the Functional Assessment Short Test between none, mind, moderate, and severe functional impairment.
Heat-stable carbetocin — an analog of oxytocin — was found to be noninferior to oxytocin in preventing hemorrhage associated with vaginal birth and may be beneficial in low- and middle-income countries.
Grass, other weeds, and unclassified pollen were significantly associated with increased risk for asthma hospitalization in young children.
The researchers noted that these findings highlight the complexity of obesity as a disease that shares a common etiology with some psychiatric and addictive disorders.
Circulating hepatic markers may predict the risk for diabetes in women.
In a multicenter study, researchers used high-quality ultrasound imaging to identify characteristics of pure ovarian clear cell carcinoma.
The new Flash Glucose Monitoring System enables patients to wear the sensor for up to 14 days compared with the existing FreeStyle Libre System that was approved for 10-day wear.
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
An increase in guideline-recommended preventive services may be associated with a decrease in patient utilization of each suggested service, which may have a negative impact on patient life expectancy or quality of life.
There is a lack of evidence supporting the benefits of combination drug therapy over monotherapy for the management of low back pain and sciatica.
The European League Against Rheumatism has issued their 2018 recommendations for physical activity in patients with inflammatory arthritis and osteoarthritis.
Variation exists in opioid prescribing practices among clinicians in single-hospital systems, which prompts concern about the potential for opioid overprescribing.
The ENGOT-OV16/NOVA trial showed improvements in progression-free survival in patients with ovarian cancer with and without the germline BRCA mutation.
This novel agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.
Previous studies have suggested that analgesic medicine use may have a protective effect for patients with ovarian cancer.
Nemolizumab Effective for Moderate, Severe Atopic Dermatitis Inadequately Controlled With Topical Therapy
For patients with moderate to severe atopic dermatitis inadequately controlled with topical therapies, the anti-IL-31 receptor A humanized monoclonal antibody nemolizumab may provide benefit.
This represents the prospective study confirming an independent relationship between cardiovascular mortality and oxidative DNA damage in type 2 diabetes.
Childhood obesity continues to be a public health issue that requires improved policies and interventions at both the individual and population level.
A significant decline in rotavirus disease-associated hospitalization, emergency department visits, and physician office visits was demonstrated in children younger than 5 years following implementation of the rotavirus vaccine.
Investigators examined the effect of consuming a Mediterranean-style diet for 1 year on inflammatory response and bone health in the elderly.
As the neurodegenerative processes of Alzheimer disease and Parkinson disease are different, early cognitive impairment also present differently in these diseases.
Compared with human neutral protamine Hagedorn insulin, basal insulin analogs do not reduce risk of hypoglycemia-linked ED visits or hospital admissions in T2D.
AGREE [A Working Group on PPI-REE) was convened to update the previously published guidelines on diagnostic criteria for eosinophilic esophagitis.
Postpartum Pain Management Recommendations From the American College of Obstetricians and Gynecologists
A committee from the American College of Obstetricians and Gynecologists formulated several recommendations for safely managing pain and fatigue in women during the early postpartum period.
Women receiving the inactivated influenza vaccine demonstrated superior antibody response compared with those receiving the live attenuated influenza vaccine.
Investigators added hepatitis C virus and HIV screening tests to standard trauma activation laboratory orders.
Patients are increasingly recording physician visits on their phones, should physicians do the same. MPR spoke with physician who advocates for recording in clinical practice.
Serologically assessed collagen remodeling plays a key role in the severity of COPD, as determined by airflow limitation and dyspnea, as well as in disease outcomes.
L-Glutamine oral treatment with or without hydroxyurea reduces pain crises better than placebo in individuals with sickle cell disease.
Vaccinated women and girls living with HIV may be at greater risk for HPV vaccine failure compared with women and girls without HIV.
Coordinated treatment programs may improve treatment outcomes in patients with hepatitis C infection.
Wellness travel comes in many forms: from coastal bike rides to weeklong workout programs with celebrity trainers.
Currently, there are no US consensus on best clinical practice guidelines that incorporate multispecialty recommendations for evaluating cognitive impairment that are thought to be due to Alzheimer's disease and Related Dementias (ADRD) for use by physicians and nurse practitioners.
Maternal lithium use in the first trimester of pregnancy may increase the risk for infant malformations.
Recurrent hypertensive disease of pregnancy is associated with increased risk for early all-cause and some cause-specific mortality.
Infectious disease experts from Emory University School of Medicine recommend that patients contemplating travel to Zika-affected areas consult with their care providers regarding travel plans and potential Zika virus testing.
Effectiveness of care and healthcare resource use for diabetes or cardiovascular disease were comparable among patients receiving care from an NP vs those managed by a PA.
The Kaiser Family Foundation recently released results from a new poll examining the public's view on women's issues.
Metformin use during the first trimester of pregnancy is not correlated with an increased risk of congenital anomalies.
Interrelationship Between Celiac Disease, Self-Reported Wheat Sensitivity, and Functional GI Disorders
Individuals with clinically diagnosed celiac disease are at greater risk for chronic gastrointestinal symptoms, possibly fitting modified Rome criteria for irritable bowel syndrome and functional dyspepsia.
Fidaxomicin demonstrated the strongest evidence for being the most effective treatment in providing a long-term cure for C difficile infection.
Causes of death in patients with epilepsy were assessed to determine the presence of cardiac pathology.
The use of multiple sun protection measures was defined as the use of 2 or more of these measures more than 50% of the time when the individual was outdoors.
Exemption from vaccination is common in Arizona school districts due to lack of trust in medical establishments.
Respiratory symptoms were more common in older children compared with infants who presented with food-induced anaphylaxis.
Women with preeclampsia with severe features had increased right ventricular systolic pressure and decreased global right ventricular longitudinal systolic strain.
The relationship between bullous pemphigoid and dipeptidyl peptidase-4 inhibitors in type 2 diabetes.
Single high-dose liposomal amphotericin B (L-AmB) is non-inferior to daily dosed L-AmB at the standard dose in treatment of fungal clearance in HIV-associated cryptococcal meningitis.
Therapy Focusing on Mindfulness, Interoception Improves Outcomes for Women With Substance Use Disorder
These findings are consistent with emerging neurocognitive models linking interoception to emotion regulation and related health outcomes, providing valuable input in improving substance use disorder treatment.
The Endocrine Society, European Society of Endocrinology, and Pediatric Endocrine Society issue guidelines for the management of hypothalamic-pituitary and growth disorders in childhood cancer survivors.
First-line chemotherapy in combination with bevacizumab, compared with chemotherapy alone, may benefit patients with ovarian cancer and elevated neutrophil-to-lymphocyte ratios.
American emergency medicine physicians have been taking measures to address the ongoing opioid crisis, which affects emergency departments throughout the country.
Radiofrequency denervation, typically used to treat lumbar and cervical zygapophyseal joint pain, has shown efficacy in treating thoracic zygapophyseal joint pain.
A study was conducted to evaluate the oxazolidinone resistance mechanisms of enterococci bacteria.
An analysis of population data on cancer incidence, survival, and mortality revealed that early interventions and improvements to treatments contributed to a 26% decline in cancer deaths from 1991 to 2015.
No significant difference was identified in combination CA125/CEA ratio vs CEA alone in distinguishing ovarian neoplasms from ovarian metastases.
Study patients who received Avastin plus chemotherapy followed by Avastin alone, had a greater median PFS vs patients who received chemotherapy alone (18.2 months vs 12 months; hazard ratio [HR] 0.62, 95% CI, 0.52-0.75; P<.0001).
Investigators examined rates, predictors, and outcomes of neuroimaging in pediatric and adolescent patients who presented to the ED with a headache.
Differences Between Cyclothymic Disorder and Unspecified Bipolar Disorder in Youth May Indicate Course of Disorder
Investigators sought to determine the differences between youth with cyclothymic disorder and bipolar disorder not otherwise specified.
Consensus guidelines regarding the use of ketamine for the management of acute pain have been approved.
Siblings of patients with rheumatoid arthritis appear to have an increased risk for acute coronary syndrome, which suggests there is a shared susceptibility between the 2 conditions.
The administration of PCV7 and PCV13 reduced the number of ambulatory visits for otitis media in pediatric patients.
This retrospective study sought to assess migraine patterns in 69 menopausal women between ages 40 and 60 who were treated at Partners Healthcare Hospitals for concurrent migraine headache.
These data show that ASD may arise from an early neurobiological difference in response to rewarding social stimuli, which could result in reduced social motivation.
Thinning of the retinal nerve fiber layer has been linked to worsening cognitive function and may be valuable in identifying individuals who may be at risk for cognitive decline.
The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.
A panel discussion event held at the US Food and Drug Administration gathered patients with chronic pain and FDA officials, to reconcile concerns around prescriptions of opioid medications with the needs of these patient populations.
Sign Up for Free e-newsletters
Clinical Advisor Articles
- In Shocking Opposition, Trump Administration Denies Decades of Breastfeeding Research
- ADA Releases Updated Guidelines for Managing Pediatric Type 1 Diabetes
- Characteristics of Menstrual Cycle Associated With Early Natural Menopause
- Perspectives on USPSTF AF Screening Recommendation
- No Impact on Carotid Artery Intima-Media Thickness Following Cessation of Menopausal Hormone Therapy
- FDA to Review Gimoti for Diabetic Gastroparesis in Adult Women
- First Generic Version of EpiPen Gets FDA Approval
- AHA/ACC: Updated Management Guidelines for Adult Congenital Heart Disease
- Copy Number Abnormalities May Inform Survival, Drug Resistance
- International Antiviral Society-USA Updates Recommendations for HIV Treatment and Prevention