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Pediatric Subcommittee Presentation on Pharmacologic Control of Drooling. John V. Kelsey, D.D.S. Lisa Mathis M.D. Division of Dermatologic and Dental Drug Products 24 April 2001. Issues for the Pediatric Subcommittee. Drooling is a problem in children with neurological impairments

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pediatric subcommittee presentation on pharmacologic control of drooling

Pediatric Subcommittee Presentation onPharmacologic Control of Drooling

John V. Kelsey, D.D.S.

Lisa Mathis M.D.

Division of Dermatologic and Dental Drug Products

24 April 2001

issues for the pediatric subcommittee
Issues for the Pediatric Subcommittee
  • Drooling is a problem in children with neurological impairments
  • Currently no approved pharmacologic therapies
  • Special considerations for studying drugs in this patient population

Pediatric Subcommittee 4/24/01

questions for the pediatric subcommittee
Questions for the Pediatric Subcommittee
  • Assessment of adverse events in this population
  • Appropriate formulations
  • Development of useful dosing information
  • Ethical and legal considerations

Pediatric Subcommittee 4/24/01

division of dermatologic and dental drug products ddddp hfd 540
Division of Dermatologic and Dental Drug Products(DDDDP, HFD-540)

Pediatric Subcommittee 4/24/01

agenda
Agenda
  • John V. Kelsey, D.D.S.
  • Lisa Mathis, M.D.
  • Benjamin Wilfond, M.D.
  • Maria Pena, M.D.
  • Ross Hays, M.D.

Pediatric Subcommittee 4/24/01

agenda cont d
Agenda (cont’d)
  • Scott Stiefel, M.D.
  • Murray Goldstein, D.O.
  • Belinda Hurlburt
  • Open public hearing
  • Subcommittee discussion of issues/questions

Pediatric Subcommittee 4/24/01

autonomic nervous system
Autonomic Nervous System
  • Involuntary nervous system
  • Innervates heart, blood vessels, visceral organs, smooth muscle, glands
  • Sympathetic v. parasympathetic systems
  • Acetylcholine
  • Muscarinic receptors

Pediatric Subcommittee 4/24/01

innervation of salivary glands
Innervation of Salivary Glands
  • Both sympathetic and parasympathetic stimulate
  • Acetylcholine is neurotransmitter for both
  • Muscarinic (M3) receptors

Pediatric Subcommittee 4/24/01

reasons drooling requires intervention
Reasons Drooling Requires Intervention
  • May lead to aspiration
  • Can lead to maceration of skin
  • Predisposes to secondary infection
  • May compromise education
  • May affect placement

Pediatric Subcommittee 4/24/01

other cholinergic effects
Other Cholinergic Effects
  • Dilation of pupils
  • Increased heart rate
  • Decreased gut motility
  • Urinary retention
  • Reduced sweating

Pediatric Subcommittee 4/24/01

summary
Summary
  • Pharmacologic target for controlling drooling is the muscarinic receptors
  • Antimuscarinic drugs are currently used off-label
  • Antimuscarinics are not selective and extrasalivary antimuscarinic effects can be unpleasant and dangerous

Pediatric Subcommittee 4/24/01

summary cont d
Summary (cont’d)
  • Studies are needed to safely and properly dose these products
  • Dose-ranging and assessment of adverse events is problematic in CP patients

Pediatric Subcommittee 4/24/01

slide13

Pediatric Subcommittee Presentation onPharmacologic Control of Drooling

John V. Kelsey, D.D.S.

Lisa Mathis M.D.

Division of Dermatologic and Dental Drug Products

24 April 2001

Pediatric Subcommittee 4/24/01

slide14

Issues for the Pediatric Subcommittee

  • Drooling is a problem in children with neurological impairments
  • Currently no approved pharmacologic therapies
  • Special considerations for studying drugs in this patient population

Pediatric Subcommittee 4/24/01

drooling
Drooling
  • Significant problem in children with cerebral palsy and other neurologic conditions
  • Not a result a hypersalivation
  • Impaired motor function results in difficulty swallowing

Pediatric Subcommittee 4/24/01

prevalence of cerebral palsy 1
Prevalenceof Cerebral Palsy1
  • 1.5 to 2.5 per 1000 live births
  • Approximately 400,000 - 800,000 children
  • Approximately 400,000 adults
  • Nolan J, Chalkiadis G.A.,Low J., et al, Anesthesia and pain management in cerebral palsy, Anesthesia,2000; 55:32-41

Pediatric Subcommittee 4/24/01

prevalence of drooling 4
Prevalence of Drooling4
  • 25-35% of patients with CP have some degree of drooling
  • Approximately 10% require intervention
  • Several other conditions with drooling
    • Down’s Syndrome, CVAs, hemiparesis, Rett’s Syndrome

Camp-Bruno J, Winsberg B, Green Parsons A, Abrams J, Efficacy of Benztropine Therapy for Drooling, Dev Med Child Neuro, 1989; 40: 340-343

Pediatric Subcommittee 4/24/01

reasons drooling requires intervention18
Reasons Drooling Requires Intervention
  • May lead to aspiration
    • Can be life threatening, leads to secondary pneumonia, pulmonary inflammation (RAD)
  • Can lead to maceration of skin
    • Breakdown of skin can be very painful, similar to a burn
    • Predisposes to secondary infection

Pediatric Subcommittee 4/24/01

reasons drooling requires intervention19
Reasons Drooling Requires Intervention
  • May compromise education
  • May affect placement

Pediatric Subcommittee 4/24/01

methods used to control drooling
Methods Used to Control Drooling
  • Behavioral
    • Oromotor therapy
    • Behavioral modification
  • Pharmacologic
  • Surgical
    • Irreversible
    • Many risks associated with surgery

Pediatric Subcommittee 4/24/01

pharmacologic control
Pharmacologic Control
  • Antimuscarinics Used to Inhibit Salivation
    • Benztropine
    • Glycopyrrolate
    • Scopolamine
    • Trihexyphenidyl
    • Others

Pediatric Subcommittee 4/24/01

antimuscarinics
Antimuscarinics
  • Not approved for chronic use in children
    • Acute use in pre-anesthesia
  • No pediatric formulation
  • Limited efficacy, safety, dosing information from clinical studies

Pediatric Subcommittee 4/24/01

slide23

Antimuscarinic Effects

  • Neurologic
    • Headache
    • Irritability, nervousness
    • Confusion, disorientation
    • Depression
  • Special Senses
    • Blurred vision
    • Loss of taste

Pediatric Subcommittee 4/24/01

slide24

Antimuscarinic Effects

  • Gastrointestinal
    • Nausea
    • Vomiting
    • Paralytic ileus
    • Constipation
  • Cardiovascular
    • Tachycardia
    • Palpitations

Pediatric Subcommittee 4/24/01

slide25

Antimuscarinic Effects

  • Urogenital
    • Urinary retention
    • Dysuria
  • Other
    • Hyperthermia
    • Xerostomia

Pediatric Subcommittee 4/24/01

clinical trials necessary to evaluate new formulations
Clinical Trials Necessary to Evaluate New Formulations
  • Increase safety and consistency in administration
  • Appropriate concentration would allow caregivers to titrate dose in small increments

Pediatric Subcommittee 4/24/01

clinical studies necessary to determine pediatric dosing
Clinical Studies Necessary to Determine Pediatric Dosing
  • In indications other than drooling, optimal dose must be individualized
  • Response is variable
  • Degree of drooling at baseline poor predictor of response
  • Small dose adjustments must be made until benefit is achieved or side effects occur

Pediatric Subcommittee 4/24/01

slide29

Effects of Atropine in Relation to Dose

  • 0.5 mg - Slight cardiac slowing, some dryness of mouth, inhibition of sweating
  • 1.0 mg - Tachycardia, definite dryness of mouth, dilatation of pupil
  • 2.0 mg - Tachycardia, palpitations, marked dryness of mouth, blurring of near vision
  • 5.0 mg - All above symptoms marked, restlessness, fatigue, headache, decreased urination, reduced intestinal peristalsis

Pediatric Subcommittee 4/24/01

challenges of conducting clinical trials in children with special needs
Challenges of Conducting Clinical Trials in Children with Special Needs:
  • Patient selection
  • Consent/assent/communication
  • Efficacy and safety evaluation

Pediatric Subcommittee 4/24/01

efficacy assessment
Efficacy Assessment
  • What dose provides balance between control of drooling and adverse events?
  • Efficacy is predictable, but absolute xerostomia is not in the best interest of the patient

Pediatric Subcommittee 4/24/01

efficacy assessment32
Efficacy Assessment
  • Drooling can vary from hour to hour, assessments must be multiple
  • What objective tools can be used to measure efficacy?
    • Teacher’s Drooling Scale
  • Who will administer tools?

Pediatric Subcommittee 4/24/01

safety assessment
Safety Assessment
  • Assessment of pain and discomfort can be difficult in target population
  • Self reporting of pain and discomfort is “gold standard”
    • Patients with cognitive disability or inability to communicate cannot self report
    • Failure to recognize side effects could lead to patient suffering, morbitity

Pediatric Subcommittee 4/24/01

safety assessment34
Safety Assessment
  • Adverse events can be serious
  • Pain Scales have been developed
    • Checklists of behavioral and/or physiologic characteristics
  • Who will administer tools?

Pediatric Subcommittee 4/24/01

conclusions
Conclusions
  • Drooling can be a serious problem
  • Pharmacologic control appears effective
  • There is a need for well-designed studies to provide information on dose-related safety and efficacy
  • Studies must be conducted in a manner that respects the rights of the patients and results in beneficial clinical information

Pediatric Subcommittee 4/24/01