Embed Size (px)
Citation preview
Ipecac Syrup: Ipecac Syrup: Regulatory History Regulatory History
Ipecac Syrup: Ipecac Syrup: Regulatory History Regulatory History
Nonprescription DrugsNonprescription DrugsAdvisory Committee MeetingAdvisory Committee Meeting
Arlene Solbeck, M.S. Arlene Solbeck, M.S.
Interdisciplinary Scientist, Division of OTC Drug ProductsInterdisciplinary Scientist, Division of OTC Drug Products
Nonprescription DrugsNonprescription DrugsAdvisory Committee MeetingAdvisory Committee Meeting
Arlene Solbeck, M.S. Arlene Solbeck, M.S.
Interdisciplinary Scientist, Division of OTC Drug ProductsInterdisciplinary Scientist, Division of OTC Drug Products
Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research
2Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
ContentContentContentContent
• The OTC Drug Monograph Process
• Regulatory History for Ipecac Syrup
• Highlights from the 1985 Tentative Final Monograph
– Proposed Labeling
• Some Final Monograph Issues
• Summary
• The OTC Drug Monograph Process
• Regulatory History for Ipecac Syrup
• Highlights from the 1985 Tentative Final Monograph
– Proposed Labeling
• Some Final Monograph Issues
• Summary
3Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
OTC Drug Monograph ProcessOTC Drug Monograph Process(The OTC Drug Review)(The OTC Drug Review)
OTC Drug Monograph ProcessOTC Drug Monograph Process(The OTC Drug Review)(The OTC Drug Review)
• Established in 1972
• Active ingredient based review
• ingredient: ipecac
• class: poison treatment
• Final Monograph states conditions for marketing and required labeling
• Ipecac syrup is regulated under the monograph process
• Established in 1972
• Active ingredient based review
• ingredient: ipecac
• class: poison treatment
• Final Monograph states conditions for marketing and required labeling
• Ipecac syrup is regulated under the monograph process
4Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
OTC Drug Monograph ProcessOTC Drug Monograph Process(3 Phases)(3 Phases)
OTC Drug Monograph ProcessOTC Drug Monograph Process(3 Phases)(3 Phases)
• Advance Notice of Proposed Rulemaking
(ANPR) Advisory Review Panel Report
• Tentative Final Monograph (TFM)
• Final Monograph (FM)
• The rulemaking for ipecac syrup is in the Final
Monograph phase
• Advance Notice of Proposed Rulemaking
(ANPR) Advisory Review Panel Report
• Tentative Final Monograph (TFM)
• Final Monograph (FM)
• The rulemaking for ipecac syrup is in the Final
Monograph phase
5Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
FDA’s First Regulation for Ipecac SyrupFDA’s First Regulation for Ipecac SyrupPre-OTC Drug ReviewPre-OTC Drug Review
FDA’s First Regulation for Ipecac SyrupFDA’s First Regulation for Ipecac SyrupPre-OTC Drug ReviewPre-OTC Drug Review
• In 1965, “Ipecac Syrup; warnings and directions for OTC sale” was added as a new regulation (now codified at 21 CFR 201.308).– immediate availability of ipecac syrup for use in poisoning emergencies
necessitated quick and easy availability for consumers.
– recommended by the Am. Acad. of Pediatrics, Am. Assoc. of Poison Control
Centers, AMA, and the Medical Advisory Board of the FDA.
– FDA Commissioner: “ipecac syrup in 1 fluid ounce containers should be
permitted to be sold without prescription for emergency use to cause
vomiting in poisoning”.
• In 1965, “Ipecac Syrup; warnings and directions for OTC sale” was added as a new regulation (now codified at 21 CFR 201.308).– immediate availability of ipecac syrup for use in poisoning emergencies
necessitated quick and easy availability for consumers.
– recommended by the Am. Acad. of Pediatrics, Am. Assoc. of Poison Control
Centers, AMA, and the Medical Advisory Board of the FDA.
– FDA Commissioner: “ipecac syrup in 1 fluid ounce containers should be
permitted to be sold without prescription for emergency use to cause
vomiting in poisoning”.
6Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
FDA’s First Regulation for Ipecac SyrupFDA’s First Regulation for Ipecac SyrupPre-OTC Drug ReviewPre-OTC Drug Review
FDA’s First Regulation for Ipecac SyrupFDA’s First Regulation for Ipecac SyrupPre-OTC Drug ReviewPre-OTC Drug Review
•Usual dosage: 15 mL in persons over 1 year of age
•Not to be used in unconscious persons
•Not to be administered after certain kinds of poisons
•strychnine•corrosives•petroleum distillates
Before using, call physician, the Poison Control Center,
or hospital emergency room immediately
for advice
Ipecac SyrupIpecac Syrup
Principal Display Panel
Labeling
Principal Display Panel
Labeling
Warnings and Directions
Warnings and Directions
7Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
Regulatory History- Regulatory History- Monograph ProcessMonograph ProcessRegulatory History- Regulatory History- Monograph ProcessMonograph Process
• Advance Notice of Proposed Rulemaking ANPR (1975)– Advisory Review Panel on OTC Laxative, Antidiarrheal, Emetic, and
Antiemetic Drug Products (LAEA Panel)
– LAEA Panel classified ipecac syrup as a Category I (safe and effective) emetic
• Tentative Final Monograph (1978)– FDA’s tentative conclusions on comments submitted in response to the
1975 Panel’s report
• infants under 1 year - 5 to 10 mL followed by 4-8 ounces liquid
• infants over 1 year, children, adults - 15mL followed by 8-16 ounces liquid
• do not administer milk or carbonated beverages with ipecac
• administer second dose after 20 min. if vomiting doesn’t occur
• do not administer in semiconscious or unconscious persons
• Drug Interaction Precaution
• Advance Notice of Proposed Rulemaking ANPR (1975)– Advisory Review Panel on OTC Laxative, Antidiarrheal, Emetic, and
Antiemetic Drug Products (LAEA Panel)
– LAEA Panel classified ipecac syrup as a Category I (safe and effective) emetic
• Tentative Final Monograph (1978)– FDA’s tentative conclusions on comments submitted in response to the
1975 Panel’s report
• infants under 1 year - 5 to 10 mL followed by 4-8 ounces liquid
• infants over 1 year, children, adults - 15mL followed by 8-16 ounces liquid
• do not administer milk or carbonated beverages with ipecac
• administer second dose after 20 min. if vomiting doesn’t occur
• do not administer in semiconscious or unconscious persons
• Drug Interaction Precaution
8Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
Regulatory History- Regulatory History- Monograph Process Monograph Process (con’t)(con’t)Regulatory History- Regulatory History- Monograph Process Monograph Process (con’t)(con’t)
• Advance Notice of Proposed Rulemaking ANPR (1982)
– Advisory Review Panel on OTC Miscellaneous Internal Drugs (MI Panel)
reviewed kit containing ipecac and activated charcoal
– MI Panel classified ipecac syrup and activated charcoal as Category 1
(safe and effective) to treat acute toxic ingestion
• Tentative Final Monograph (1985)– Based on the recommendations of both the LAEA and MI Panels and
comments on those reports
– Contains FDA’s tentative conclusions and proposed labeling on OTC
poison treatment drugs
• Advance Notice of Proposed Rulemaking ANPR (1982)
– Advisory Review Panel on OTC Miscellaneous Internal Drugs (MI Panel)
reviewed kit containing ipecac and activated charcoal
– MI Panel classified ipecac syrup and activated charcoal as Category 1
(safe and effective) to treat acute toxic ingestion
• Tentative Final Monograph (1985)– Based on the recommendations of both the LAEA and MI Panels and
comments on those reports
– Contains FDA’s tentative conclusions and proposed labeling on OTC
poison treatment drugs
9Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
1985 Tentative Final Monograph1985 Tentative Final Monograph Principal Display Panel LabelingPrincipal Display Panel Labeling
1985 Tentative Final Monograph1985 Tentative Final Monograph Principal Display Panel LabelingPrincipal Display Panel Labeling
If possible call a Poison Control Center, emergency medical facility, or health professional for help before using this product.
If help cannot be reached quickly, follow the directions.
Read the warnings and directions as soon as you buy this product.
Insert emergency phone numbers in space provided on the label.
30 mL
Ipecac Syrup
10Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
1985 Tentative Final Monograph - 1985 Tentative Final Monograph - DirectionsDirections1985 Tentative Final Monograph - 1985 Tentative Final Monograph - DirectionsDirections
• Proposed Dosages
– adults and children 12 years and older: 30 mL followed by 8-16 ounces
liquid
– children 1-under 12 years: 15 mL followed by 8-16 ounces liquid
– children 6 mo. to under 1 year: 5 mL followed by 4-8 ounces liquid
– children under 6 months: not recommended
• Proposed Directions
– water or other clear liquids to be administered following ipecac;
milk should not be given
– repeat dosage if vomiting does not occur within 30 min.
– keep patients active and moving
• Proposed Dosages
– adults and children 12 years and older: 30 mL followed by 8-16 ounces
liquid
– children 1-under 12 years: 15 mL followed by 8-16 ounces liquid
– children 6 mo. to under 1 year: 5 mL followed by 4-8 ounces liquid
– children under 6 months: not recommended
• Proposed Directions
– water or other clear liquids to be administered following ipecac;
milk should not be given
– repeat dosage if vomiting does not occur within 30 min.
– keep patients active and moving
11Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
1985 Tentative Final Monograph - 1985 Tentative Final Monograph - WarningsWarnings1985 Tentative Final Monograph - 1985 Tentative Final Monograph - WarningsWarnings
• Proposed Warnings
– do not use in persons who are not fully conscious
– do not use this product if turpentine, corrosives (such as
alkalies (lye) and strong acids), or petroleum distillates (such
as kerosene, gasoline, paint thinner or furniture polish) have
been ingested.
– do not administer milk
• Poison Treatment Kit
– Drug Interaction Precaution: Do not give activated charcoal
until after the patient has vomited, unless directed by a health
professional.
• Proposed Warnings
– do not use in persons who are not fully conscious
– do not use this product if turpentine, corrosives (such as
alkalies (lye) and strong acids), or petroleum distillates (such
as kerosene, gasoline, paint thinner or furniture polish) have
been ingested.
– do not administer milk
• Poison Treatment Kit
– Drug Interaction Precaution: Do not give activated charcoal
until after the patient has vomited, unless directed by a health
professional.
12Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
XXXXX
IPECAC SYRUP USPEMETIC ALCOHOL 1.75%
If possible, call a Poison Control Center, emergency facilityor health professional for help before using this product. Ifhelp cannot be reached quickly, follow the directions on this label. Read the warnings and directions as soon as you buy this product. Insert emergency phone number(s) in space provided on the label_____________________________
Contents 1 FL.OZ. (30 mL)
POISONFIRST
AID
DIRECTIONS: Adults and children 12years of age and over: oral dosage is 2 tablespoonfuls (30 milliliters or 1 bottle)followed by 1-2 glasses (8-16 ozs.) of water or other clear liquid as directedby a health professional. Children 1 to under 12 years of age: oral dosage is1 tablespoonful (15 milliliters or 1/2 bottle)followed by 1 to 2 glasses or water orother clear liquid or as directed by a health professional. Children 6 monthsto under 1 year of age: oral dosage is1 teaspoonful (5 milliliters) followed by 1/2 to 1 glass (4-8 ozs.) of water or otherclear liquid or as directed by a healthprofessional. Children under 6 months of age: Do not administer unless directed by a health professional. If vomiting does not occur within 30 minutes, repeat thedose. If previous attempts to contact a poison control center, emergency medicalfacility, or health professional wereunsuccessful, continue trying. Keeppatient active and moving. Save the container of poison.
ACTIVE INGREDIENTS; IpecacF.E. ALSO CONTAINS: Glycerin,Sodium Benzoate, Sucrose,Purified Water. WARNING: Donot use if shrink band around capimprinted “Sealed For YourProtection” is broken or missing.INDICATIONS: For emergency use to cause vomiting ofswallowed poisons. WARNING:Do not use in persons who arenot fully conscious. Do not use this product, unless directed bya health professional, if turpentine,corrosives, such as alkalies (lye)and strong acids, or petroleumdistillates, such as kerosene, gasoline, paint thinner, cleaningfluid, or furniture polish, have beeningested. Do not administer milk with this product.INTERACTION PRECAUTION:Activated charcoal will absorbipecac syrup. Do not giveactivated charcoal until after the patient has vomited, unlessdirected by a health professional.
SAFETY SEALED
Sample LabelSample LabelSample LabelSample Label
13Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
Comments After the 1985 Tentative Final Comments After the 1985 Tentative Final Monograph PublishedMonograph Published
Comments After the 1985 Tentative Final Comments After the 1985 Tentative Final Monograph PublishedMonograph Published
• FDA received comments from
– 6 poison control centers
– 6 hospitals
– 7 medical schools
– 3 trade associations
– 5 manufacturers
– 3 law firms
– 14 individuals
• Comments for OTC availability– OTC availability of ipecac syrup for treating accidental
poisonings in the public interest medically and financially
• FDA received comments from
– 6 poison control centers
– 6 hospitals
– 7 medical schools
– 3 trade associations
– 5 manufacturers
– 3 law firms
– 14 individuals
• Comments for OTC availability– OTC availability of ipecac syrup for treating accidental
poisonings in the public interest medically and financially
14Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
Comments Comments (con’t)(con’t)Comments Comments (con’t)(con’t)
• Comments about safety aspects of using ipecac
– concern for proper management of poisoning
– children under 1 year of age may have an
increased risk for aspiration and dehydration
– potential risks of ipecac syrup induced vomiting in
the elderly
– concern that ipecac syrup not be misused or
abused
• Comments about safety aspects of using ipecac
– concern for proper management of poisoning
– children under 1 year of age may have an
increased risk for aspiration and dehydration
– potential risks of ipecac syrup induced vomiting in
the elderly
– concern that ipecac syrup not be misused or
abused
15Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
Recent DevelopmentsRecent Developments
Post - 1985 Tentative Final MonographPost - 1985 Tentative Final Monograph
Recent DevelopmentsRecent Developments
Post - 1985 Tentative Final MonographPost - 1985 Tentative Final Monograph
• Medical literature and some poison control and
clinical toxicology societies indicate the safety
and efficacy of ipecac syrup should be
reevaluated
• Clinical studies question benefit of ipecac
• Medical literature and some poison control and
clinical toxicology societies indicate the safety
and efficacy of ipecac syrup should be
reevaluated
• Clinical studies question benefit of ipecac
16Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
Recent Developments (con’t)Recent Developments (con’t)Recent Developments (con’t)Recent Developments (con’t)
• Recommends reevaluation of ipecac’s benefit
– American Academy of Clinical Toxicology - 1997 position
statement
– European Association of Poison Centers & Clinical Toxicologists -
1997 position statement
– American Board of Applied Toxicology (endorses 1997 statement)
– Canadian Association of Poison Control Centers (endorses 1997
statement)
• Recommends ipecac for accidental poisonings
– American College of Emergency Physicians
– American Medical Association
• Recommends reevaluation of ipecac’s benefit
– American Academy of Clinical Toxicology - 1997 position
statement
– European Association of Poison Centers & Clinical Toxicologists -
1997 position statement
– American Board of Applied Toxicology (endorses 1997 statement)
– Canadian Association of Poison Control Centers (endorses 1997
statement)
• Recommends ipecac for accidental poisonings
– American College of Emergency Physicians
– American Medical Association
17Advisory Committee Meeting Advisory Committee Meeting June 12, 2003June 12, 2003
SummarySummarySummarySummary
• Poison Treatment rulemaking is in the Final Monograph stage.
• Ipecac syrup and activated charcoal are the only two ingredients classified as Category I (safe and effective) for OTC poison treatment.
• Should ipecac syrup remain OTC?
• Poison Treatment rulemaking is in the Final Monograph stage.
• Ipecac syrup and activated charcoal are the only two ingredients classified as Category I (safe and effective) for OTC poison treatment.
• Should ipecac syrup remain OTC?
