TERATOLOGY INFORMATION TERATOLOGY INFORMATION SERVICESSERVICES

Definition of TeratogenDefinition of Teratogen

Teratogen - any agent or factor which can Teratogen - any agent or factor which can cause abnormalities in form or function in cause abnormalities in form or function in an exposed fetusan exposed fetus

Word teratogen comes from 2 sources:Word teratogen comes from 2 sources:– Greek - teratos, meaning monsterGreek - teratos, meaning monster– Latin - monstrum, meaning omenLatin - monstrum, meaning omen

Known Human TeratogensKnown Human Teratogens

•Accutane•Ace inhibitors•Alcohol•Androgens•Anticonvulsants (Dilantin, valproate, carbamazepine)•Anticoagulants (warfarin)•Antithyroid meds (PTU, radioisotopes)•Cancer chemotherapeuticagents

•Cigarettes•Cocaine•Hyperthermia•Lithium•Maternal metabolic disorders•Methyl mercury•Tetracycline•Therapeutic radiation•Thalidomide•TORCH infections•Vitamin A

Need for Teratology InformationNeed for Teratology Information

• Growing demand for health care professionals to provide teratogen information

• The state of knowledge regarding the teratogenic effects of drugs and chemicals is constantly evolving and is often uncertain

• Although there are many sources of teratology information, the quality of information varies - Drug Compendiums – PDR - Textbooks - Briggs: Drugs in Pregnancy and

Lactation - Databases - Reprorisk Module® (electronic

versions of Reprotext, REPROTOX, Shepard’s Catalog, and TERIS

- Journal articles - Teratology Information Services

Teratology Information Services Teratology Information Services (TIS(TIS))

• Comprehensive multidisciplinary resources for up-to-date, authoritative information on reproductive effects of exposures during pregnancy

• Access to expertise in teratology, dysmorphology, toxicology, pharmacology, epidemiology, clinical genetics, infectious diseases, obstetric / maternal fetal medicine, radiation biology, occupational and environmental health

• Most are located at major medical universities or affiliated with state public health departments

• Services available to health-care providers and patients, usually at no cost

What Are Teratology Information What Are Teratology Information Services (TIS’ s)?Services (TIS’ s)?

TERATOLOGY INFORMATION SERVICES OR TERATOLOGY INFORMATION SERVICES OR PREGNANCY RISK LINESPREGNANCY RISK LINES– Service – Toll-free phone consultation to patients or Service – Toll-free phone consultation to patients or

health care providers about exposures during health care providers about exposures during pregnancypregnancy

– Education – to public and academic groups, including Education – to public and academic groups, including medical, nursing, genetic counseling, pharmacy and medical, nursing, genetic counseling, pharmacy and othersothers

– Research – collaborative projects looking at outcomes Research – collaborative projects looking at outcomes of exposures to specific agentsof exposures to specific agents

Developing a Risk AssessmentDeveloping a Risk Assessment

Questions:Questions:– TimingTiming– DoseDose– Family, medical and pregnancy historyFamily, medical and pregnancy history– Other exposuresOther exposures

Literature reviewLiterature review

Teratology Information in a Product LabelTeratology Information in a Product Label

FDA Pregnancy Categories

Percentage of Labeled Drugs

• Category A: Controlled studies in human show no risk < 1%• Category B: Animal Studies show no risk but no controlled studies 20%

in pregnant women or Animal studies show a risk not confirmed in human studies.• Category C: Animal studies show a risk but no human studies available 65%

orNo animal or human studies available.

Drug should be used only if benefit justifies risk.• Category D: Evidence of human fetal risk but benefits of maternal 7%

therapy may outweigh risks.• Category X: Animal studies or human findings have demonstrated 7%

fetal abnormalities and

Risk of drug use in pregnancy clearly outweights any possible benefit. Drug is contraindicated in women who are or may become pregnant.

Use of FDA Pregnancy Use of FDA Pregnancy CategoriesCategories

Assigned prior to release of a drug and rarely changed Assigned prior to release of a drug and rarely changed despite new datadespite new data

Often assigned on the basis of animal studies Often assigned on the basis of animal studies

Do not differentiate between different pregnancy Do not differentiate between different pregnancy situationssituations

Misinterpretation of risk - incorrectly implies dichotomy of Misinterpretation of risk - incorrectly implies dichotomy of risk or gradation of riskrisk or gradation of risk

Examples of Problems With Examples of Problems With FDA CategoriesFDA Categories

SSRI’s – category C – no evidence of SSRI’s – category C – no evidence of increased incidence of birth defects but increased incidence of birth defects but growing concern about neonatal growing concern about neonatal adaptationadaptation

Oral contraceptives – category X – no Oral contraceptives – category X – no increase in birth defects but should not be increase in birth defects but should not be used in pregnancyused in pregnancy

Providing a Risk AssessmentProviding a Risk Assessment

Collection of data on specific agentCollection of data on specific agent

Interpretation of data based on intake Interpretation of data based on intake informationinformation

Elicit callers’ knowledge and sourceElicit callers’ knowledge and source

Discuss 3-5% background riskDiscuss 3-5% background risk

Review risk vs. benefitReview risk vs. benefit

OTIS Members in the OTIS Members in the Mountain StatesMountain States

ARIZONAARIZONA

UTAHUTAH

TEXASTEXAS

Utah - Pregnancy RisklineUtah - Pregnancy Riskline

Established in 1984Established in 1984Receives nearly 10,000 calls each yearReceives nearly 10,000 calls each year328-2229 or 1-800-822-2229 328-2229 or 1-800-822-2229

Texas Teratogen Information Texas Teratogen Information ServiceService

Established in 1991Established in 1991

State fundedState funded

Receives 1,000 calls annuallyReceives 1,000 calls annually

1-800-733-47271-800-733-4727

Arizona Pregnancy RisklineArizona Pregnancy Riskline

Established in 1988Established in 1988State funding was obtained in 1999State funding was obtained in 1999Receives 2,500 calls annuallyReceives 2,500 calls annuallyServes as the referral number for states Serves as the referral number for states which do not have services – funded by which do not have services – funded by the CDCthe CDC1-888-285-34101-888-285-3410

Organization of Teratology Information Services

www.otispregnancy.org

National Phone Number:(866) 626-OTIS(866) 626-6847