Device Authorizations: MONARCH system for ADHD, XVIVO system for lung transplantation, COMANECI for intracranial aneurysms, NERIVIO MIGRA for migraine, ZIKV Detect 2.0 for Zika virus detection

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MONARCH external Trigeminal Nerve Stimulation (eTNS) System

NeuroSigma

INDICATION FOR USE: Treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

ADDRESSING UNMET NEED: Non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind

GENERIC DEVICE TYPE:Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder

  • Prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead

DEVICE DESCRIPTION:

  • Cell-phone sized device generates low-level electrical pulse and connects via wire to a small patch that adheres to a patient’s forehead
  • Delivers low-level electrical stimulation to branches of trigeminal nerve, which sends therapeutic signals to the parts of the brain involved in ADHD
  • Neuroimaging studies show that eTNS increases activity in brain regions that are known to be important in regulating attention, emotion and behavior

EFFECTIVENESS & SAFETY:

  • Clinical trial, n=62 children with moderate to severe ADHD, eTNS vs. placebo
  • Primary endpoint: Improvement on clinician-administered ADHD Rating Scale, ADHD-RS
  • Subjects using eTNS device had statistically significant improvement in ADHD symptoms vs. placebo group
  • At end of week four, the average ADHD-RS score in eTNS decreased from 34.1 to 23.4 points, versusdecrease from 33.7 to 27.5 points in placebo
  • Most common side effects: Drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue; no serious adverse events 

IDENTIFIED RISKS: Adverse tissue reaction, Injury or discomfort from electrical stimulation, including burns and nerve damage, Misuse that may result in device failure, user discomfort, or injury, Skin irritation or infection from use on broken skin 

REGULATORY PATHWAY: De Novo request

  • Regulation:21 CFR 882.5898
  • Regulation Name: Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder
  • Regulatory Class: Class II
  • Product Code: QGL

CLASSIFICATION ORDER


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XVIVO PERFUSION SYSTEM 

Xvivo Perfusion Inc. 

INDICATION FOR USE: For use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reassessed for transplantation.

ADDRESSING UNMET NEED: 

  • Lung transplantation is life-saving treatment for end-stage lung disease
  • Many patients die while waiting for suitable lungs for transplant
  • Only 15 percent of lungs from deceased donors suitable for transplantation
  • New device to temporarily ventilate, oxygenate, and perfuse preservation solution through lungs that were initially thought to be unacceptable for transplant

DESCRIPTION:

  • Consists of XPS Perfusion Cart Hardware, fluid path and non-fluid path disposables, XPS Cart Software, and STEEN Solution
  • STEEN Solution™ is clear, sterile, non-pyrogenic, non-toxic physiological salt solution containing human serum albumin (HSA) and dextran 40
  • Extracellular (low potassium) electrolyte solution with physiological colloid-osmotic pressure (COP) designed for use as a temporary continuous normothermic machine perfusion solution for ex vivo assessment of isolated lungs after removal from the donor

EFFECTIVENESS & SAFETY:

  • Study involving 332 sets of donor lungs allocated into three groups
  • Control group: Lungs initially deemed suitable for transplant that were provided to 116 recipients after standard preservation
  • Second group: Lungs initially deemed unsuitable for transplant and, after being perfused with the Xvivo Perfusion System, were implanted into 110 recipients
  • Third group: Perfused with the Xvivo Perfusion System and were still deemed not suitable after the perfusion, and therefore were not implanted into patients
  • One-year survival rate: 94% (Control) vs 86.4% (Second and third groups)
  • Difference in rates was not deemed to be clinically significant
  • Most common adverse events: Acute rejection, bronchial complications, respiratory failure and infections

REGULATORY PATHWAY: PMA

  • Classification: III
  • Procode: PHO
  • Originally granted marketing authorization in 2014 under humanitarian device exemption (HDE), limiting use to maximum of 8,000 patients per year
  • PMA pathway allows increased number of lungs to be available for transplant
  • Post-Approval requirements: Long-Term Post Approval Studies

LABEL


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COMANECI Embolization Assist Device

Rapid Medical

INDICATION FOR USE: For use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm defines the neck width as ≥ 4 mm or a dome-to-neck ratio < 2

GENERIC TYPE OF DEVICE: Temporary coil embolization assist device

  • Prescription device intended for temporary use in the neurovasculature to  mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.

RISKS AND MITIGATIONS:

  • Infection: Sterilization validation, Pyrogenicity testing, Shelf life testing, Labeling
  • Adverse tissue reaction: Biocompatibility evaluation
  • Tissue or vessel damage: Non-clinical performance testing, Clinical performance testing, Labeling
  • Thromboembolic event:  Non-clinical performance testing, Clinical performance testing, Labeling
  • Coils ensnarement: Non-clinical performance testing, Clinical performance testing, Labeling

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 882.5955
  • Regulation Name: Temporary coil embolization assist device
  • Regulatory Class: Class II
  • Product Code: PUU

CLASSIFICATION ORDER


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NERIVIO MIGRA 

Theranica Bioelectronics ltd

INDICATION FOR USE: For acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura.

GENERIC DEVICE TYPE: Trunk and limb electrical stimulator to treat headache

  • Device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient’s head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously

RISKS AND MITIGATIONS:

  • Adverse tissue reaction: Biocompatibility evaluation
  • Electrical, mechanical, or thermal hazards that may result in user discomfort or injury: Non-clinical performance testing, Electrical, mechanical, and thermal safety testing, Electromagnetic compatibility (EMC) testing, Software verification, validation, and hazard analysis, Labeling
  • Interference with other devices: Electromagnetic compatibility (EMC) testing, Labeling
  • Software malfunction leading to injury or discomfort: Software verification, validation, and hazard analysis
  • Hardware malfunction leading to injury or discomfort: Non-clinical performance testing, Shelf life testing, Labeling
  • Use error that may result in user discomfort, injury, or delay treatment for headaches: Labeling

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 882.5899
  • Regulation Name: Trunk and limb electrical stimulator to treat headache
  • Regulatory Class: Class II
  • Product Code: QGT

CLASSIFICATION ORDER


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ZIKV Detect 2.0 IgM Capture ELISA

InBios

INDICATION FOR USE: Intended for the qualitative detection of Zika virus IgM
antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection.
The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.

ADDRESSING UNMET NEED:

  • 1st Commercial serology kit to receive FDA Marketing Authorization
  • Previous tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s Emergency Use Authorization (EUA) authority

GENERIC DEVICE TYPE: Zika virus serological reagents

  • In vitro diagnostic devices that consist of antigens or antibodies for the detection of Zika virus or Zika antibodies in human specimens from individuals who have signs
    and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The detection aids in the diagnosis of current or recent Zika virus infection or serological status. Negative results obtained with this test do not preclude the possibility of Zika virus infection, past or present. Positive results should be interpreted with consideration of other clinical information and laboratory findings and should not be used as the sole basis for treatment or other patient management decisions.

RISKS AND MITIGATIONS:

  • Risk of false results: Device description, performance characteristics, validation procedures, labeling
  • Failure to correctly interpret test results: Device description, performance characteristics, Labeling
  • Failure to correctly operate the device: Device description, performance characteristics, validation procedures, Labeling

REGULATORY PATHWAY: De Novo request (previously authorized via EUA)

  • Regulation Number: 21 CFR 866.3935
  • Regulation Name: Zika Virus Serological Reagents
  • Regulatory Class: Class II
  • Product Code: QFO

CLASSIFICATION ORDER


Image credits: NeuroSigma, Xvivo, Rapid Medical, Theranica, InBios

Drug and Vaccine Authorizations: EVENITY for osteoporosis, DENGVAXIA for Dengue, MAVYRET for Hep C in children, BENLYSTA in SLE, TIBSOVO for AML, VYNDAQEL/VYNDAMAX for cardiomyopathy, RUZURGI for LEMS

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EVENITY (romosozumab-aqqg) injection, for subcutaneous use 

Amgen

INDICATION FOR USE: Treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
Limitations of Use : Anabolic effect wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered

ADDRESSING UNMET NEED:
  • > 10 million US women osteoporosis; weakened bones likely to fracture
  • Approval provides women with postmenopausal osteoporosis with high risk of fracture with a new treatment

MECHANISM OF ACTION: Monoclonal antibody that inhibits action of sclerostin, a regulatory factor in bone metabolism; increases bone formation and, to a lesser extent, decreases bone resorption

EFFICACY:
  • 2 randomized, double-blind studies, placebeo and alendronate controlled respectively, n>11,000 women with postmenopausal osteoporosis
  • Endpoints: Risk of a new fracture in spine (vertebral fracture): 73% lowered risk vs. placebo, maintained over the second year of trial when Evenity.  50% lowered risk vs. two years of alendronate alone
  • Evenity followed by alendronate reduced risk of fractures in other bones (nonvertebral fractures) vs. alendronate alone
SAFETY:
  • Boxed Warning: Potential risk for myocardial infarction, stroke and cardiovascular death
  • Common side effects: Joint pain, headache, injection site reactions
REGULATORY PATHWAY: BLA
  • Pediatric assessments: Waived; do not apply to population
  • Postmarketing requirements: Cardiovascular safety

LABEL


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DENGVAXIA (Dengue Tetravalent Vaccine, Live) Suspension for Subcutaneous Injection

Sanofi Pasteur

INDICATION FOR USE: indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas
Limitations of use: Not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown; Safety and effectiveness have not been established in individuals living in dengue non-endemic areas who travel to dengue endemic areas

ADDRESSING UNMET NEED:

  • FDA committed to working with CDC and WHO to combat public health threats
  • Approval is important step toward reducing impact of virus in endemic US regions

MECHANISM OF ACTION: Elicits dengue-specific immune responses against four dengue virus serotypes

EFFICACY:

  • Three randomized, placebo-controlled studies, n=35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and Asia Pacific region, 9-16 years of age
  • Endpoint: Symptomatic virologically-confirmed dengue (VCD); DENGVAXIA 76%  effective in preventing VCD in individuals who previously had laboratory- confirmed dengue disease

SAFETY: 

  • Most commonly reported side effects: Headache, muscle pain, joint pain, fatigue, injection site pain and low-grade fever

REGULATORY PATHWAY: BLA

  • Priority Review and a Tropical Disease Priority Review Voucher
  • Postmarketing Study Requirement/Commitments: Safety and effectiveness in children 2 to < 9 years of age

PACKAGE INSERT


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MAVYRET (glecaprevir and pibrentasvir) tablets

AbbVie

INDICATION FOR USE: Treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)

ADDRESSING UNMET NEED:  First treatment for all genotypes of hepatitis C in pediatric patients

MECHANISM OF ACTION: Fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis C virus

EFFICACY:

  • Open-label study, n=47  adolescent subjects 12 -< 18 years  with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis, 8 or 16 weeks.
  • 100% had no virus detected in blood 12 weeks after finishing treatment, suggesting  infection had been cured

SAFETY:

  • Adverse reactions observed were consistent with those observed in adults
  • Most commonly reported adverse reactions: Headache and fatigue

REGULATORY PATHWAY: Supplemental NDA

  • Initial US approval (NDA) in adult patients in 2017

LABEL


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BENLYSTA (belimumab) intravenous infusion

GlaxoSmithKline

INDICATION FOR USE: Treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy

ADDRESSING UNMET NEED:

  • First treatment for pediatric patients with Systemic Lupus Erythematosus (SLE)
    • Benlysta has been approved for use in adult patients since 2011

EFFICACY:

  • International, randomized, doubleblind, placebo-controlled, 52-week, n=93  pediatric patients with a clinical diagnosis of SLE
  • Primary efficacy endpoint: SLE Responder Index (SRI-4) at Week 52; numerically higher patients achieving a response in SRI-4 with BENLYSTA vs. placebo

SAFETY:

  • Warning for mortality, serious infections, hypersensitivity and depression
  • Most common side effects: Nausea, diarrhea and fever, infusion reactions

REGULATORY PATHWAY: sBLA, Priority review

LABEL


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TIBSOVO (ivosidenib) tablets

Agios Pharmaceuticals

RealTime IDH1 Assay

Abbott

INDICATION FOR USE: Treatment of newly-diagnosed acute myeloid leukemia (AML)  with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy

ADDRESSING UNMET NEED: First-line treatment for AML with IDH1 mutation

EFFICACY:

  • Open-label, single-arm, multicenter clinical trial, n=28 (newly-diagnosed AML with IDH1 mutation detected by Abbott RealTimeTM IDH1 Assay
  • Endpoints: Rate of complete remission (CR) or complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, conversion rate from transfusion dependence to transfusion independence
  • CR+CRh :42.9%, 41.2% achieved transfusion independence lasting at least 8 weeks

SAFETY:

  • Boxed Warning for Differentiation Syndrome which may be life-threatening or fatal
  • Adverse reactions: Diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome and myalgia

REGULATORY PATHWAY: sNDA

  • Used Real-Time Oncology Review pilot program
  • Priority Review and Orphan Product designation
  • Postmarketing requirement: Determine safe dose in mild, moderate and severe hepatic impairment

LABEL


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VYNDAQEL (tafamidis meglumine) and VYNDAMAX (tafamidis) capsules 

FoldRx (Pfizer subsidiary)

INDICATION FOR USE: Treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization

ADDRESSING UNMET NEED:

  • Transthyretin-mediated amyloidosis is rare, debilitating, often fatal disease
  • Approval an important advancement in treatment of cardiomyopathy caused by transthyretin-mediated amyloidosis

MECHANISM OF ACTION: Selective stabilizer of TTR;  slows dissociation into monomers, the rate-limiting step in the amyloidogenic process

EFFICACY:

  • Multicenter, international, randomized, double-blind, placebo-controlled study
    n=441 patients with wild type or hereditary ATTR-CM
  • Endpoints: All-cause mortality and frequency of cardiovascular-related hospitalizations
  • Significant reduction (p=0.0006) in all-cause mortality and frequency of
    cardiovascular-related hospitalizations with Vyndaqel / Vyndamax group

SAFETY:

  • No drug-associated side effects identified
  • May cause fetal harm when administered to pregnant woman

REGULATORY PATHWAY: NDA

  •  Fast Track, Priority Review and Breakthrough Therapy designations
  • Orphan Drug designation

LABEL


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RUZURGI (amifampridine) tablets 

Jacobus Pharmaceutical Company

INDICATION FOR USE: Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age

ADDRESSING UNMET NEED:

  • LEMS is a rare autoimmune disorder affecting connection between nerves and muscles
  • First approved treatment for LEMS specifically in children

MECHANISM OF ACTION: Broad spectrum potassium channel blocker

EFFICACY:

  • Randomized, double-blind, placebo-controlled withdrawal study
  • Primary measure of efficacy: Change in Triple Timed Up and Go test (3TUG)  and self-assessment scale for LEMS-related weakness
  • Less impairment with Ruzurgi; greater perceived weakening with placebo

SAFETY: 

  • Most common side effects: Burning or prickling sensation (paresthesia), abdominal pain, indigestion, dizziness and nausea
  • Seizures in patients without a history of seizures

REGULATORY PATHWAY: NDA,  Priority Review and Fast Track designations, Orphan Drug designation

LABEL


Image credits: Amgen, Sanofi, AbbVie, Agios, GSK, Pfizer, Jacobus

News & Views: CDRH reorg implementation, Deep Learning and patient safety, Patient Preference Information, CMS reimbursement for novel devices, Biologics development, Addressing health disparities, Safer prescribing of psychoactives with opioids, Marketed Device safety measures, Warnings for insomnia drugs,

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Team-Based Approach to Medical Device and Radiological Product Evaluation and Quality

Operationalizing  Office of Product Evaluation and Quality (OPEQ)

  • Identifying, Resolving, and Communicating Safety Issues — Faster and Better
  • Informing New Product Approvals with Latest Safety Data
  • Advancing Safer and More Effective Innovative Technologies
  • Enhancing Evidence Generation Throughout the Total Product Life Cycle
  • Fostering Employee Engagement, Opportunity, and Success

CDRH Directory


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Capturing Patient Experience Through Deep Learning

  • FDA developing computational approaches to use deep learning, a form of artificial intelligence (AI), to extract  adverse events of drugs and therapeutic biologics (using standard MedDRA terms) automatically from NDAs
  • Patient narratives in NDAs used to train a neural network to make correct MedDRA coding decisions using diverse natural language processing (NLP)
  • Development of user-friendly tool to check MedDRA  coding accuracy of previous submissions, such as adverse event reports from drug developers

READ


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Using Patient Preference Information (PPI) in Medical Device Evaluation

PPI defined as

  • Qualitative/Quantitative assessments of relative patient desirability or acceptability of specified alternatives or choices among outcomes or other attributes
  • Clarify what benefits and risks are most important to patients
  • Impact premarket clinical study design, benefit-risk assessments, postmarket evaluation

Agency has identified  Priority List of Patient Preference-Sensitive Areas

Parameters for patient preference-sensitive areas

  • Better understand full impact of disease and treatment options on patients
  • Patients may value benefits-risks  differently from healthcare professionals
  • Population-level differences in patient perspectives not well understood
  • Significant public health impact

READ


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CMS comprehensive strategy to foster innovation for transformative medical devices 

Goal to get new innovations to  beneficiaries concurrent with FDA approval

  • Removing government barriers to innovation
  • Harmonizing CMS coverage, coding, and payment processes

Initiatives

  • CMS-FDA Parallel Review Program – FDA approval and CMS coverage on same day
  • Modernize payment policies for ‘Breakthrough Devices’ designation – waive  requirement for “substantial clinical improvement”
  • More frequent, semi-annual, opportunities to request HCPCS code
  • Consider commercial payments in determining payments for innovative Durable Medical Equipment (DME)
  • Reevaluiate guidelines for new hospital technology add-on payment (NTAP)
  • Enhance ease of billing for new technologies
  • New guidance on Local Coverage Decisions (LCD) – contractors not authorized to make coverage determinations to automatically non-cover any item or service

READ


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Efforts to Advance the Development of Biologics

Biologics, regulated by CBER, are either living cells or tissues, or are made from them, such as stem cells and genetically engineered immune cells

  • Drugs: Includes blood components/derivatives, vaccines, allergenics, and cellular/gene therapies
  • Devices: In vitro diagnostic tests for screening blood supply, for manufacturing blood and tissue products
  • Safety and efficacy linked to quality and consistency of manufacturing

Cellular and Gene Therapy Approvals in 2018

  • LUXTURNA for heritable disorder that causes blindness: retinal dystrophy associated with mutations in the RPE65 gene
  • YESCARTA, CAR-T cell therapy  to treat adults with certain types of relapsed or refractory diffuse large B cell non-Hodgkin lymphoma

Vaccine and Blood Product Approvals in 2018

  • HEPLISAV-B, Hepatitis B vaccine to prevent infection caused by all known subtypes of hepatitis B virus in adults 18 of age and older
  • SHINGRIX, vaccine for shingles prevention in adults 50 years of age and older
  • COBAS Zika Test and the PROCLIEX Zika Virus Assay for Zika detection in human plasma

READ


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Addressing Health Disparities Through Communication, Research, and Collaboration

Office of Minority Health and Health Equity (OMHHE) promotes and protects health of diverse populations and strives for health equity

READ


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Preclinical Research to Achieve Safer Prescribing of Psychoactive Therapeutics for Patients Who Use Opioids

More than 30%  of deaths from opioids involve use of benzodiazepines, commonly used for anxiety or insomnia

  • Might worsen the respiratory effects of opioids in patients being treated for pain. To achieve this goal
  • Gaps in evidence needed for safer prescribing

FDA developing Preclinical Model to address gaps 

  • Rat study and predict interaction of psychoactive sedative drugs and opioids
  • Exposed to psychoactive drug with or without the opioid oxycodone
  • Determine respiratory effect and opioid-induced respiratory depression
  • Measurement of achieved blood concentrations over time to determine how to administer the drugs so that tested drug and opioid reach simultaneous peak levels

READ


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Marketed Device Safety Measures

SURGICAL MESH for transvaginal repair of pelvic organ prolapse – Sales stopped 

  • FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling-distributing immediately
  • Manufacturers- Boston Scientific and Coloplast- have not demonstrated reasonable assurance of safety and effectiveness for these high risk  devices these devices

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SURGICAL STAPLERS- New steps to reduce risks

  • Large number of adverse events reports  including opening of staple line, malformation of staples, misfiring, difficulty in firing, failure of stapler to fire staple, misapplied staples
  • Increasing regulatory requirements from Class I (low risk) to Class II (moderate risk)
  • Require labeling to provide adequate information for use, including hazards, contraindications, information for safe and effective use

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BREAST IMPLANTS- New efforts to protect health and ensure safety

  • Weighing risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  • Improve labeling to communicated risk of BIA-ALCL, greater risk of BIA-ALCL with textured implants, and risk of developing systemic symptoms to women and health care professionals professionals

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Stronger warnings about rare but serious incidents related to certain prescription insomnia medicines

Rare, complex sleep behaviors specifically associated with use of eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist)

  • Serious injuries because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake (e.g. using a stove)
  • Have also resulted in deaths

Labeling updates

  • Boxed Warning –most prominent warning
  • Contraindication-strongest warning
  • Avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem

READ


Image credit: FDA