united states food and drug administration

Importance: Approximately 27% of adults in the US and Canada report having ever used cannabis for medical purposes. An estimated 10.5% of the US population reports using cannabidiol (CBD), a chemical compound extracted from cannabis that does not have psychoactive effects, for therapeutic purposes.

Observations: Conditions for which cannabinoids have approval from the US Food and Drug Administration include HIV/AIDS-related anorexia, chemotherapy-induced nausea and vomiting, and certain pediatric seizure disorders. A meta-analysis of randomized clinical trials reported a small but significant reduction in nausea and vomiting from various causes (eg, chemotherapy, cancer) when comparing prescribed cannabinoids (eg, dronabinol, nabilone) with placebo or active comparators (eg, alizapride, chlorpromazine; standardized mean difference [SMD], -0.29 [95% CI, -0.39 to -0.18]). A meta-analysis of randomized clinical trials among patients with HIV/AIDS reported that cannabinoids had a moderate effect on increasing body weight compared with placebo (SMD, 0.57 [95% CI, 0.22 to 0.92]). Evidence-based guidelines do not recommend the use of inhaled or high-potency cannabis (≥10% or 10 mg Δ9-tetrahydrocannabinol [Δ9-THC]) for medical purposes. High-potency cannabis compared with low-potency cannabis use is associated with increased risk of psychotic symptoms (12.4% vs 7.1%) and generalized anxiety disorder (19.1% vs 11.6%). A meta-analysis of observational studies reported that 29% of individuals who used cannabis for medical purposes met criteria for cannabis use disorder. Daily inhaled cannabis use compared with nondaily use was associated with an increased risk of coronary heart disease (2.0% vs 0.9%), myocardial infarction (1.7% vs 1.3%), and stroke (2.6% vs 1.0%). Evidence from randomized clinical trials does not support the use of cannabis or cannabinoids for most conditions for which it is promoted, such as acute pain and insomnia. Before considering cannabis or cannabinoids for medical use, clinicians should consult applicable institutional, state, and national regulations; evaluate for drug-drug interactions; and assess for contraindications (eg, pregnancy) or conditions in which risks likely outweigh benefits (eg, schizophrenia or ischemic heart disease). For patients using cannabis or cannabinoids for treatment of medical conditions, clinicians should discuss harm reduction strategies, including avoiding concurrent use with alcohol or other central nervous system depressants such as benzodiazepines, using the lowest effective dose, and avoiding use when driving or operating machinery.

Conclusions and relevance: Evidence is insufficient for the use of cannabis or cannabinoids for most medical indications. Clear guidance from clinicians is essential to support safe, evidence-based decision-making. Clinicians should weigh benefits against risks when engaging patients in informed discussions about cannabis or cannabinoid use.

Author/s:

Michael Hsu, Arya Shah, Ayana Jordan, Mark S Gold, Kevin P Hill

ADHD Diagnosis and Treatment in Children and Adolescents

Alex Haga — Fri, 05 Apr 2024 00:54:05 +0000

Date Added:

April 4, 2024

Journal/Publication:

Comparative Effectiveness Review

Publisher:

Agency for Healthcare Research and Quality

Publication Date:

March 1, 2024

URL:

ADHD Diagnosis and Treatment in Children and Adolescents

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

https://doi.org/10.23970/AHRQEPCCER267

An evidence-based summary of what we currently know about the diagnosis and treatment of children with ADHD. James W. Mold, MD, MPH

Free full text

View

Objective. The systematic review assessed evidence on the diagnosis, treatment, and monitoring of attention deficit hyperactivity disorder (ADHD) in children and adolescents to inform a planned update of the American Academy of Pediatrics (AAP) guidelines.

Data sources. We searched PubMed®, Embase®, PsycINFO®, ERIC, clinicaltrials.gov, and prior reviews for primary studies published since 1980. The report includes studies published to June 15, 2023.

Review methods. The review followed a detailed protocol and was supported by a Technical Expert Panel. Citation screening was facilitated by machine learning; two independent reviewers screened full text citations for eligibility. We abstracted data using software designed for systematic reviews. Risk of bias assessments focused on key sources of bias for diagnostic and intervention studies. We conducted strength of evidence (SoE) and applicability assessments for key outcomes. The protocol for the review has been registered in PROSPERO (CRD42022312656).

Results. Searches identified 23,139 citations, and 7,534 were obtained as full text. We included 550 studies reported in 1,097 publications (231 studies addressed diagnosis, 312 studies addressed treatment, and 10 studies addressed monitoring). Diagnostic studies reported on the diagnostic performance of numerous parental ratings, teacher rating scales, teen/child self-reports, clinician tools, neuropsychological tests, EEG approaches, imaging, and biomarkers. Multiple approaches showed promising diagnostic performance (e.g., using parental rating scales), although estimates of performance varied considerably across studies and the SoE was generally low. Few studies reported estimates for children under the age of 7. Treatment studies evaluated combined pharmacological and behavior approaches, medication approved by the Food and Drug Administration, other pharmacologic treatment, psychological/behavioral approaches, cognitive training, neurofeedback, neurostimulation, physical exercise, nutrition and supplements, integrative medicine, parent support, school interventions, and provider or model-of-care interventions. Medication treatment was associated with improved broadband scale scores and ADHD symptoms (high SoE) as well as function (moderate SoE), but also appetite suppression and adverse events (high SoE). Psychosocial interventions also showed improvement in ADHD symptoms based on moderate SoE. Few studies have evaluated combinations of pharmacological and youth-directed psychosocial interventions, and we did not find combinations that were systematically superior to monotherapy (low SoE). Published monitoring approaches for ADHD were limited and the SoE is insufficient.

Conclusion. Many diagnostic tools are available to aid the diagnosis of ADHD, but few monitoring strategies have been studied. Medication therapies remain important treatment options, although with a risk of side effects, as the evidence base for psychosocial therapies strengthens and other nondrug treatment approaches emerge.

Author/s:

Peterson, BS, Trampush, J, Maglione, M, Bolshakova, M, Brown, M., Rozelle, M

Over-the-Counter Progestin-Only Oral Contraceptives

Rowan Hutchins — Tue, 03 Oct 2023 05:00:00 +0000

Date Added:

October 3, 2023

Journal/Publication:

JAMA

Publisher:

AMA

Publication Date:

September 15, 2023

URL:

Over-the-Counter Progestin-Only Oral Contraceptives

Type:

Patient Education Materials

Format:

Poster

DOI (1):

10.1001/jama.2023.17781

Keywords

estrogen

contraceptive

oral contraceptives

PMID (1):

37713188

MeSH

Progesterone Congeners

united states food and drug administration

Contraceptive Agents

Information for patients about the new OTC progestin-only birth control pills. James W. Mold, MD, MPH

Free full text

View

Oral contraceptives are pills that prevent pregnancy. Most oral contraceptive pills contain 2 hormones—estrogen and progestin—that are naturally present in the bodies of individuals who are capable of becoming pregnant. Progestin-only oral contraceptive pills can be used by individuals who should avoid additional estrogen, such as those who smoke, are breastfeeding, or have heart disease or diabetes.

In the US, nearly all oral contraceptives require a prescription. In July 2023, the US Food and Drug Administration (FDA) approved the first oral contraceptive pill (Opill) that will be available without a prescription.

Author/s:

Fleurant, Erin, Mokashi, Mugdha, Simon, Melissa

Long-Term Health Outcomes in Obstructive Sleep Apnea: A Systematic Review of Comparative Studies Evaluating Positive Airway Pressure and the Validity of Breathing Measures as Surrogate Outcomes

Aubrey Delammermore — Sun, 11 Dec 2022 06:00:00 +0000

Date Added:

December 11, 2022

Journal/Publication:

Agency for Healthcare Research and Quality

Publisher:

US Department of Health and Human Services

Publication Date:

December 1, 2022

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

Keywords

CPAP

Obstructive sleep apnea

sleep apnea

systematic review

breathing measures

MeSH

Sleep Apnea, Obstructive

Patient Acuity

united states food and drug administration

continuous positive airway pressure

Sleepiness

An AHRQ-sponsored systematic review of evidence relating to the impact of CPAP on various outcomes in adults with obstructive sleep apnea. The abstract is on pages vi-vii. Spoiler alert: Very little hard evidence of benefit on key outcomes. James W. Mold MD, MPH.

Free full text

Background. Obstructive sleep apnea (OSA) is a disorder characterized by periods of airflow
cessation (apnea) or reduced airflow (hypopnea) during sleep. The diagnosis and severity of
OSA, and response to therapy, have historically been assessed using the apnea-hypopnea index
(AHI). However, several definitions of this measure exist, and the utility of the AHI and
associated measures as valid surrogate measures of health outcomes has been questioned. OSA is
commonly treated with the use of continuous positive airway pressure (CPAP) devices during
sleep. The efficacy of CPAP, including for Food and Drug Administration (FDA)
clearance/approval, has been based on changes in AHI, but the long-term effect of CPAP on
health outcomes and the role of disease severity (as measured by AHI) or sleepiness symptoms
on the putative effect of CPAP are unclear.
Methods. We searched Medline, Embase, the Cochrane databases, CINAHL, and
ClinicalTrials.gov from January 2010 through March 22, 2021; we screened reference lists of the
2011 Agency for Healthcare Research and Quality (AHRQ) OSA report and other systematic
reviews for earlier studies. We included only randomized controlled trials (RCT) and
nonrandomized comparative studies (NRCS) of CPAP that adjusted for potential confounders for
CPAP evaluation. We also included other comparative studies that reported both changes in
potential intermediate or surrogate measures (e.g., AHI) and effects on health outcomes. All
studies had to report effects on prespecified long-term (12 months for most outcomes) health
outcomes in adults with OSA. We did not evaluate sleepiness, other symptoms, or intermediate
outcomes. We excluded observational studies that did not directly compare treatment options.
Results. The 52 identified studies used highly inconsistent criteria to define breathing measures
(apneas, hypopneas, and oxygen desaturation). Definitions of respiratory disturbance events
(e.g., apneas, hypopneas) and criteria to define or categorize severity of OSA are highly
inconsistent across studies, despite frequent claims of using standard national or international
definitions. Possible differences in study findings based on heterogeneity of OSA and sleep study
measures could not be elucidated. Among 31 studies that directly compared CPAP and no CPAP
(29 studies) or sham CPAP (2 studies), 14 were RCTs (12 intention-to-treat [ITT]) and 17 were
NRCSs (11 analyses of CPAP users versus nonusers).
With one exception, RCTs did not find statistically significant effects for any cardiovascular
(CV) outcome. RCTs did not provide evidence that CPAP affects the risk of all-cause mortality
(summary effect size [ES] 0.89, 95% confidence interval [CI] 0.66 to 1.21), CV mortality
(summary ES 0.99, 95% CI 0.64 to 1.53), stroke (summary ES 0.99, 95% CI 0.73 to 1.35),
myocardial infarction (summary ES 1.05, 95% CI 0.78 to 1.41), or composite CV outcomes (ES
range 0.42 to 1.10 across studies, all statistically nonsignificant); all with low strength of
evidence (SoE). The three RCTs that aimed to be powered for composite CV events failed to
vi
show a significant or clinically meaningful effect. The NRCSs, overall, found significant
adjusted associations between CPAP use and all-cause mortality. Combining the RCTs and
NRCSs, the summary ES for all-cause mortality was ES 0.61 (95% CI 0.49 to 0.76), supporting a
low SoE of an association between CPAP use and lower risk of death. Data from the NRCSs did
not change other conclusions. Both RCTs and NRCSs provide insufficient evidence regarding
the effect of CPAP on the risk of transient ischemic attack, angina, coronary artery
revascularization, congestive heart failure, and atrial fibrillation.
RCTs also did not provide evidence that CPAP affects the risk of driving accidents or the risk of
incident diabetes (both low SoE), or that CPAP results in clinically significant changes in
depression or anxiety scores, executive cognitive function measures, or nonspecific quality of
life measures (all low SoE). RCTs provide insufficient evidence regarding the effect of CPAP on
incident hypertension, functional status measures, male or female sexual function, or days of
work missed. Data from the NRCSs did not change these conclusions.
Eligible studies provided insufficient evidence regarding possible differences in the effect of
CPAP based on patient characteristics (such as disease severity or comorbidities), different
diagnostic criteria, or whether RCTs were analyzed as ITT or “as-treated”.
Eligible studies provided insufficient evidence about adverse events due to CPAP use. Many
studies did not collect such data. Adverse events reported in the U.S. Food and Drug
Administration (FDA) database mostly related to inadequate humidification, user errors, or
device malfunction. No deaths were attributed to CPAP use.
Review of the FDA database found 163 CPAP devices used to treat adults with sleep apnea. The
large majority of FDA 510(k) Premarket Notification records cite other previously approved
CPAP devices to support claims of equivalence. The available data did not reference clinical
studies to support the device manufacturers’ claims.
Review of the National Institutes of Health’s RePORTER revealed no germane funded trials.
Review of ClinicalTrials.gov revealed a single large RCT with a mortality endpoint, but no
updating of the site since 2015 and five additional small trials (2 addressing events in patients
with paroxysmal atrial fibrillation or hypertensive pulmonary edema; 3 measuring AHI,
cognition, or kidney function).
RCTs comparing CPAP and mandibular advancement devices found no differences in depression
or anxiety symptoms (low SoE). There was insufficient evidence for other outcomes. RCTs
comparing fixed and autoCPAP found no differences in functional status; other long-term
outcomes were not reported. No eligible studies evaluated comparisons of other types of CPAP.
No studies have evaluated the validity of changes in intermediate or surrogate measures (such as
change in AHI during a clinical trial) as predictors of long-term health outcomes. No studies
reported surrogacy or mediation analyses, nor did any compare the concordance of changes in
different sleep study and symptom measures with health outcomes. Across the 15 studies that
reported both changes in intermediate or surrogate measures and effects on long-term health
vii
outcomes, data were too sparse to allow adequate cross-study evaluation of concordance between
change in any specific measure and health outcome or sleep questionnaires.
Conclusions. Studies are highly inconsistent as to how they define breathing measures during
sleep studies and OSA itself. Insufficient evidence exists to assess the validity of change in AHI
as a surrogate or intermediate measure for long-term health outcomes. Until such validation has
been conducted, it cannot be assumed that changes (e.g., improvements) in intermediate or
surrogate outcomes are correlated with long-term health outcomes.
RCTs do not provide evidence that CPAP prescription affects long-term, clinically important
outcomes. Specifically, with low SoE, RCTs do not demonstrate that CPAP affects all-cause
mortality, various CV outcomes, clinically important changes in psychosocial measures, or other
clinical events. NRCSs reported associations between CPAP use and reduced risk of all-cause
death. NRCS results did not differ from RCTs for other outcomes. We have limited confidence
that the summary estimates are close to any true effect.
Comparative studies did not adequately address whether the effect of CPAP varies based on
disease severity (e.g., as assessed by AHI), symptoms (e.g., as assessed by sleepiness scales),
other patient characteristics, different features or modes or CPAP, or different criteria or
definitions of sleep measures or OSA diagnosis.
Additional well-conducted comparative studies are needed to better assess the potential effects of
CPAP on long-term outcomes for patients with OSA, whether any particular group of patients
may benefit to a greater or lesser degree from CPAP treatment, and whether of changes in AHI
(and/or other breathing measures) are valid intermediate or surrogate measures of health
outcomes. Associations identified in comparative studies could serve as the basis for more
rigorous trials.

Author/s:

Balk, E. M., Adam, G. P., Cao, W., Bhuma, M. R., Forbes, S., Mehta, S., Panagiotou, O., D'Ambrosio, C., Trikalinos, T. A.

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022

Saige Blanchard — Mon, 31 Jan 2022 06:00:00 +0000

Date Added:

January 31, 2022

Journal/Publication:

Morbidity and Mortality Weekly Report

Publisher:

Centers for Disease Control and Prevention

Publication Date:

January 21, 2022

Issue:

Volume:

Pages:

80-84

URL:

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

https://doi.org/10.15585/mmwr.mm7103a2

Keywords

Zoster Vaccine

Immunocompromised Adults

recommendations

Advisory Committee

PMID (1):

35051134

MeSH

herpes zoster vaccine

united states food and drug administration

Vaccine Efficacy

Advisory Committees

Herpes Zoster

The CDC’s Advisory Committee on Immunization Practices recommends and the FDA has approved 2 doses of Shingrix for immunocompromised adults to reduce the risk of herpes zoster. James W. Mold, MD, MPH

Free full text

View

Zoster Vaccine Recombinant, Adjuvanted (Shingrix, GlaxoSmithKline [GSK]) is a 2-dose (0.5 mL each) subunit vaccine containing recombinant glycoprotein E in combination with adjuvant (AS01B) that was licensed in the United States for prevention of herpes zoster for adults aged ≥50 years by the Food and Drug Administration (FDA) and recommended for immunocompetent adults aged ≥50 years by the Advisory Committee on Immunization Practices (ACIP) in 2017* (1). On July 23, 2021, the FDA expanded the indication for recombinant zoster vaccine (RZV) to include adults aged ≥18 years who are or will be at increased risk for herpes zoster because of immunodeficiency or immunosuppression caused by known disease or therapy (2). On October 20, 2021, ACIP recommended 2 doses of RZV for the prevention of herpes zoster and related complications in adults aged ≥19 years† who are or will be immunodeficient or immunosuppressed because of disease or therapy. RZV is the first herpes zoster vaccine approved for use in immunocompromised persons. With moderate to high vaccine efficacy and an acceptable safety profile, RZV has the potential to prevent considerable herpes zoster incidence and related complications. This report updates previous ACIP recommendations for the prevention of herpes zoster (1,3).

Author/s:

Anderson, T. C., Masters, N. B., Guo, A., Shepersky, L., Leidner, A. J., Lee, G. M., Kotton, C. N., Dooling, K. L.

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021-22 Influenza Season

Bethie Seay — Thu, 26 Aug 2021 05:00:00 +0000

Date Added:

August 26, 2021

Type:

Public Health Announcements

MeSH

Influenza A Virus, H1N1 Subtype

SARS-CoV-2

influenza, human

vaccines, inactivated

Pregnancy Trimester, Third

Inpatients

prevalence

united states food and drug administration

Centers for Disease Control and Prevention, U.S.

Intensive Care Units

Cell Culture Techniques

delivery of health care

The 2021-2022 CDC recommendations regarding administration of influenza vaccines.

View

This report updates the 2020–21 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2020;69[No. RR-8]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For each recipient, a licensed and age-appropriate vaccine should be used. ACIP makes no preferential recommendation for a specific vaccine when more than one licensed, recommended, and age-appropriate vaccine is available. During the 2021–22 influenza season, the following types of vaccines are expected to be available: inactivated influenza vaccines (IIV4s), recombinant influenza vaccine (RIV4), and live attenuated influenza vaccine (LAIV4).

The 2021–22 influenza season is expected to coincide with continued circulation of SARS-CoV-2, the virus that causes COVID-19. Influenza vaccination of persons aged ≥6 months to reduce prevalence of illness caused by influenza will reduce symptoms that might be confused with those of COVID-19. Prevention of and reduction in the severity of influenza illness and reduction of outpatient visits, hospitalizations, and intensive care unit admissions through influenza vaccination also could alleviate stress on the U.S. health care system. Guidance for vaccine planning during the pandemic is available at https://www.cdc.gov/vaccines/pandemic-guidance/index.html. Recommendations for the use of COVID-19 vaccines are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html, and additional clinical guidance is available at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-v....

Updates described in this report reflect discussions during public meetings of ACIP that were held on October 28, 2020; February 25, 2021; and June 24, 2021. Primary updates to this report include the following six items. First, all seasonal influenza vaccines available in the United States for the 2021–22 season are expected to be quadrivalent. Second, the composition of 2021–22 U.S. influenza vaccines includes updates to the influenza A(H1N1)pdm09 and influenza A(H3N2) components. U.S.-licensed influenza vaccines will contain hemagglutinin derived from an influenza A/Victoria/2570/2019 (H1N1)pdm09-like virus (for egg-based vaccines) or an influenza A/Wisconsin/588/2019 (H1N1)pdm09-like virus (for cell culture–based and recombinant vaccines), an influenza A/Cambodia/e0826360/2020 (H3N2)-like virus, an influenza B/Washington/02/2019 (Victoria lineage)-like virus, and an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus. Third, the approved age indication for the cell culture–based inactivated influenza vaccine, Flucelvax Quadrivalent (ccIIV4), has been expanded from ages ≥4 years to ages ≥2 years. Fourth, discussion of administration of influenza vaccines with other vaccines includes considerations for coadministration of influenza vaccines and COVID-19 vaccines. Providers should also consult current ACIP COVID-19 vaccine recommendations and CDC guidance concerning coadministration of these vaccines with influenza vaccines. Vaccines that are given at the same time should be administered in separate anatomic sites. Fifth, guidance concerning timing of influenza vaccination now states that vaccination soon after vaccine becomes available can be considered for pregnant women in the third trimester. As previously recommended, children who need 2 doses (children aged 6 months through 8 years who have never received influenza vaccine or who have not previously received a lifetime total of ≥2 doses) should receive their first dose as soon as possible after vaccine becomes available to allow the second dose (which must be administered ≥4 weeks later) to be received by the end of October. For nonpregnant adults, vaccination in July and August should be avoided unless there is concern that later vaccination might not be possible. Sixth, contraindications and precautions to the use of ccIIV4 and RIV4 have been modified, specifically with regard to persons with a history of severe allergic reaction (e.g., anaphylaxis) to an influenza vaccine. A history of a severe allergic reaction to a previous dose of any egg-based IIV, LAIV, or RIV of any valency is a precaution to use of ccIIV4. A history of a severe allergic reaction to a previous dose of any egg-based IIV, ccIIV, or LAIV of any valency is a precaution to use of RIV4. Use of ccIIV4 and RIV4 in such instances should occur in an inpatient or outpatient medical setting under supervision of a provider who can recognize and manage a severe allergic reaction; providers can also consider consulting with an allergist to help identify the vaccine component responsible for the reaction. For ccIIV4, history of a severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency or any component of ccIIV4 is a contraindication to future use of ccIIV4. For RIV4, history of a severe allergic reaction (e.g., anaphylaxis) to any RIV of any valency or any component of RIV4 is a contraindication to future use of RIV4.

This report focuses on recommendations for the use of vaccines for the prevention and control of seasonal influenza during the 2021–22 influenza season in the United States. A brief summary of the recommendations and a link to the most recent Background Document containing additional information are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to U.S.-licensed influenza vaccines used according to Food and Drug Administration–licensed indications. Updates and other information are available from CDC’s influenza website (https://www.cdc.gov/flu); vaccination and health care providers should check this site periodically for additional information.

Author/s:

Grohskopf, L. A., Alyanak, E., Ferdinands, J. M., Broder, K. R., Blanton, L. H., Talbot, H. K., Fry, A. M.

Evidenced-Based Pharmacotherapies for Alcohol Use Disorder

John Bayhi — Thu, 21 May 2020 16:22:32 +0000

Date Added:

May 21, 2020

Journal/Publication:

Mayo Clinic Proceedings

Publisher:

Elsevier Inc / Mayo Foundation for Medical Education and Research

Publication Date:

May 20, 2020

Volume:

Article in Press

URL:

Evidenced-Based Pharmacotherapies for Alcohol Use Disorder

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.mayocp.2020.01.030

Keywords

MeSH

Pharmacogenomic Testing

united states food and drug administration

A review of pharmacological approaches to the treatment of alcoholism with some clinical pearls from Mayo physicians. James W. Mold, MD, MPH

Free full text

View

Pathologic alcohol use affects more than 2 billion people and accounts for nearly 6% of all deaths worldwide. There are three medications approved for the treatment of alcohol use disorder by the US Food and Drug Administration (FDA): disulfiram, naltrexone (oral and long-acting injectable), and acamprosate. Of growing interest is the use of anticonvulsants for the treatment of alcohol use disorder, although currently none are FDA approved for this indication. Baclofen, a γ-aminobutyric acid B receptor agonist used for spasticity and pain, received temporary approval for alcohol use disorder in France. Despite effective pharmacotherapies, less than 9% of patients who undergo any form of alcohol use disorder treatment receive pharmacotherapies. Current evidence does not support the use of pharmacogenetic testing for treatment individualization. The objective of this review is to provide knowledge on practice parameters for evidenced-based pharmacologic treatment approaches in patients with alcohol use disorder.

Author/s:

Fairbanks, J, Umbreit, A, Kolla, BP, Karpyak, VM, Schneekloth, TD, Loukianova, LL, Sinha, S

Treatment of Depression in Children and Adolescents: A Systematic Review. Comparative Effectiveness Review No. 224

John Bayhi — Fri, 17 Apr 2020 17:32:46 +0000

Date Added:

April 17, 2020

Journal/Publication:

AHRQ Publication No. 20-EHC005-EF

Publisher:

Agency for Healthcare Research and Quality

Publication Date:

April 10, 2020

URL:

Treatment of Depression in Children and Adolescents: A Systematic Review. Comparative Effectiveness Review No. 224

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.23970/AHRQEPCCER224

Keywords

cognitive behavioral therapy

selective serotonin reuptake inhibitors

MeSH

serotonin uptake inhibitors

paroxetine

Depressive Disorder

depressive disorder, major

united states food and drug administration

risk

Inpatients

Confidence Intervals

antidepressive agents

Cognitive Behavioral Therapy

The key findings are listed on the third page (page ii). James W. Mold, MD, MPH

Free full text

View

Background. Depressive disorders can affect long-term mental and physical health functioning among children and adolescents, including increased risk of suicide. Despite access to several nonpharmacological, pharmacological, and combined treatment options for childhood depression, clinicians contend with sparse evidence and are concerned about harms associated with treatment.

Methods. We conducted a systematic review to evaluate the efficacy, comparative effectiveness, and moderators of benefits and harms of available nonpharmacological and pharmacological treatments for children and adolescents with a confirmed diagnosis of a depressive disorder (DD)—major depressive disorder (MDD), persistent depressive disorder (previously termed dysthymia) or DD not otherwise specified. We searched five databases and other sources for evidence available from inception to May 29, 2019, dually screened the results, and analyzed eligible studies.

Results. We included in our analyses data from 60 studies (94 articles) that met our review eligibility criteria. For adolescents (study participants’ ages range from 12 to 18 years) with MDD, cognitive behavioral therapy (CBT), fluoxetine, escitalopram, and combined fluoxetine and CBT may improve depressive symptoms (1 randomized controlled trial [RCT] each, n ranges from 212 to 311); whether the magnitude of improvement is clinically significant is unclear. Among adolescents or children with MDD, CBT plus medications (8–17 years) may be associated with lower rates of relapse (1 RCT [n = 121]). In the same population (6–17 years), selective serotonin reuptake inhibitors (SSRIs) may be associated with improved response (7 RCTs [n = 1,525]; risk difference [RD], 72/1,000 [95% confidence interval (CI), 2 to 24], I2 = 9%) and functional status (5 RCTs [n = 941]; standardized mean difference, 0.16 [95% CI, 0.03 to 0.29]; I2 = 0%). For adolescents or children with any DD (7–18 years), CBT or family therapy may be associated with improvements in symptoms, response, or functional status (1 RCT each, n ranges from 64 to 99). Among children with any DD (7–12 years), family-based interpersonal therapy may be associated with improved symptoms (1 RCT, n = 38). Psychotherapy trials did not report harms. SSRIs may be associated with a higher risk of serious adverse events among adolescents or children with MDD (7–18 years; 9 RCTs [n = 2,206]; RD, 20/1,000 [95% CI, 1 to 440]; I2, 4%) and with a higher risk of withdrawal due to adverse events among adolescents with MDD (12–18 years; 4 RCTs [n = 1,296], RD, 26/1,000 [95% CI, 6 to 45]; I2, 0%). Paroxetine (1 RCT [n = 180]) may be associated with a higher risk of suicidal ideation or behaviors among adolescents with MDD (12–18 years). Evidence was insufficient to judge the risk of suicidal ideation or behavior for other SSRIs for adolescents and children with MDD or other DD (7–18 years) (10 RCTs [n = 2,368]; relative risk, 1.14 [95% CI, 0.89 to 1.45]; I2, 8%). However, this report excluded data on inpatients and those without depressive disorders, whom the Food and Drug Administration included in finding an increased risk of suicidality for all antidepressants across all indications.

Conclusion. Efficacious treatments exist for adolescents with MDD. SSRIs may be associated with increased withdrawal and serious adverse events. No evidence on harms of psychotherapy were identified.

Author/s:

Viswanathan, M, Kennedy, SM, McKeeman, J, Christian, R, Coker-Schwimmer, Cook Middleton, Bann, C, Lux, L, Randolph, Forman-Hoffman, V

Summary of Revisions: Standards of Medical Care in Diabetes—2020

John Bayhi — Sat, 14 Mar 2020 19:35:38 +0000

Date Added:

March 14, 2020

Journal/Publication:

Diabetes Care

Publisher:

American Diabetes Association

Publication Date:

January 1, 2020

Issue:

Supplement 1

Volume:

Pages:

S4-S6

URL:

Summary of Revisions: Standards of Medical Care in Diabetes—2020

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.2337/dc20-Srev

Keywords

PMID (1):

31862743

MeSH

Sodium-Glucose Transporter 2 Inhibitors

Diabetic Ketoacidosis

Ficus

Glucagon-Like Peptide-1 Receptor

glycated hemoglobin a

cardiovascular diseases

Consensus

Farmers

Cystic Fibrosis

Transients and Migrants

Pharmaceutical Preparations

depression

Smell

Patient Comfort

electronic nicotine delivery systems

Blood Glucose Self-Monitoring

celiac disease

follow-up studies

Latent Autoimmune Diabetes in Adults

seasons

social determinants of health

Standard of Care

Time-to-Treatment

united states food and drug administration

risk reduction behavior

Centers for Disease Control and Prevention

glucagon-like peptide 1

anxiety disorders

Feeding and Eating Disorders

thyroid diseases

Infections

This is a three-page summary of the 2020 updates to the ADA Guidelines for Type 2 diabetes. James W. Mold, MD, MPH

Free full text

View

No abstract available.

Cannabidiol Products Are Everywhere, but Should People Be Using Them?

Brian Desmarais — Thu, 21 Nov 2019 18:13:38 +0000

Date Added:

November 22, 2019

Journal/Publication:

Journal of the American Medical Association

Publication Date:

November 20, 2019

URL:

Cannabidiol Products Are Everywhere, but Should People Be Using Them?

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

https://doi.org/10.1001/jama.2019.17361

Keywords

CBD

MeSH

cannabis

cannabidiol

united states food and drug administration

Here is another concise review on cannabidiol. This one looks like it could be useful to give to patients who have questions about it. James W. Mold, MD, MPH

Free full text

View

Even with pharmaceutical-grade CBD, potentially dangerous adverse events can occur. With unregulated CBD products, the adverse events are unpredictable, in part because their ingredients might not be the same as those listed on the package.

Author/s:

Rubin, R.

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season

Brian Desmarais — Mon, 30 Sep 2019 13:16:17 +0000

Date Added:

September 30, 2019

Journal/Publication:

Morbidity and Mortality Weekly Report

Publication Date:

August 23, 2019

Issue:

Volume:

Pages:

1-21

URL:

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Seaso

Type:

Public Health Announcements

Format:

Article

DOI (1):

10.15585/mmwr.rr6803a1

Keywords

Flu vaccines

vaccination recommendations

Centers for Disease Control and Prevention

MeSH

vaccines, inactivated

Hemagglutinins

Influenza A Virus, H1N1 Subtype

Influenza A Virus, H3N2 Subtype

united states food and drug administration

centers for disease control and prevention (U.S.)

Contraindications

This year’s flu vaccine recommendations from the CDC. James W. Mold, MD, MPH

Free full text

View

Abstract

This report updates the 2018-19 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2018;67[No. RR-3]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. A licensed, recommended, and age-appropriate vaccine should be used. Inactivated influenza vaccines (IIVs), recombinant influenza vaccine (RIV), and live attenuated influenza vaccine (LAIV) are expected to be available for the 2019-20 season. Standard-dose, unadjuvanted, inactivated influenza vaccines will be available in quadrivalent formulations (IIV4s). High-dose (HD-IIV3) and adjuvanted (aIIV3) inactivated influenza vaccines will be available in trivalent formulations. Recombinant (RIV4) and live attenuated influenza vaccine (LAIV4) will be available in quadrivalent formulations.Updates to the recommendations described in this report reflect discussions during public meetings of ACIP held on October 25, 2018; February 27, 2019; and June 27, 2019. Primary updates in this report include the following two items. First, 2019-20 U.S. trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/Brisbane/02/2018 (H1N1)pdm09-like virus, an A/Kansas/14/2017 (H3N2)-like virus, and a B/Colorado/06/2017-like virus (Victoria lineage). Quadrivalent influenza vaccines will contain HA derived from these three viruses, and a B/Phuket/3073/2013-like virus (Yamagata lineage). Second, recent labeling changes for two IIV4s, Afluria Quadrivalent and Fluzone Quadrivalent, are discussed. The age indication for Afluria Quadrivalent has been expanded from ≥5 years to ≥6 months. The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for all persons aged ≥36 months (≥3 years). The dose volume for Fluzone Quadrivalent for children aged 6 through 35 months, which was previously 0.25 mL, is now either 0.25 mL or 0.5 mL. The dose volume for Fluzone Quadrivalent is 0.5 mL for all persons aged ≥36 months (≥3 years).This report focuses on the recommendations for use of vaccines for the prevention and control of influenza during the 2019-20 season in the United States. A brief summary of these recommendations and a Background Document containing additional information are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to U.S.-licensed influenza vaccines used within Food and Drug Administration-licensed indications. Updates and other information are available from CDC's influenza website (https://www.cdc.gov/flu). Vaccination and health care providers should check this site periodically for additional information.

Author/s:

Grohskopf, L.A., Alyanak, E., Broder, K.R., Walter, E.B., Fry, A.M., Jernigan, D.B.

Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine

Brian Desmarais — Wed, 21 Aug 2019 18:24:49 +0000

Date Added:

August 21, 2019

Journal/Publication:

Federal Register

Publisher:

U.S. Government

Publication Date:

August 21, 2019

URL:

Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine

Format:

Web Page

Keywords

Hazardous Waste

United States Environmental Protection Agency

Controlled Substances

United States Food and Drug Administration

nicotine

MeSH

Hazardous Waste

United States Environmental Protection Agency

controlled substances

nicotine

united states food and drug administration

Health Facilities

Family Characteristics

This EPA final rule for disposal of drugs and other potentially hazardous substances goes into effect on August 21, 2019. James W. Mold, MD, MPH

Free full text

View

Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. This final rule adds regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities (for both humans and animals) and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards in lieu of the existing hazardous waste generator regulations. Among other things, these new regulations prohibit the disposal of hazardous waste pharmaceuticals down the drain and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances. The new rules also maintain the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events, while ensuring their proper disposal. The new rules codify Environmental Protection Agency (EPA)'s prior policy on the regulatory status of nonprescription pharmaceuticals going through reverse logistics. Additionally, EPA is excluding certain U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) nicotine replacement therapies (NRTs) from regulation as hazardous waste and is establishing a policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics, fulfilling the commitment we made in the Retail Strategy of September 2016.

Author/s:

Unites States Environmental Protection Agency

Drug Threat Bulletin: DSUVIA (Sufentanil)

Jeffrey Wilson — Tue, 04 Dec 2018 21:45:33 +0000

Date Added:

December 4, 2018

Journal/Publication:

Threat Bulletin

Publisher:

Oklahoma Bureau of Narcotics and Dangerous Drugs

Publication Date:

November 30, 2018

Type:

Public Health Announcements

Format:

Article

Keywords

MeSH

united states food and drug administration

Sufentanil (DSUVIA), an extremely potent opiate has just been approved by the FDA.

Free full text

The US Food and Drug Administration (FDA) approved DSUVIA, the synthetic opioid sufentanil in tiny blue tablet form, on Nov. 2, 2018 for single doses ingested under the tongue. Sufentanil is chemically similar to fentanyl (the lethal narcotic showing up as fake oxycodone pills and as a cutting agent in heroin) but estimated to be five to 10 times stronger. The opioid has been administered in solution form via IV and epidural injection since 1984, and typically employed as an anesthesia during major surgery (high dose) and in low-dosages as part of pain-relieving regimen for general surgery. (ROCIC Drug Publication)

Author/s:

Oklahoma Bureau of Narcotics and Dangerous Drugs