1. TERATOLOGY INFORMATION SERVICES

2. Definition of Teratogen
Teratogen - any agent or factor which can cause abnormalities in form or function in an exposed fetus
Word teratogen comes from 2 sources:
Greek - teratos, meaning monster
Latin - monstrum, meaning omen

3. Known Human Teratogens
Cigarettes
Cocaine
Hyperthermia
Lithium
Maternal metabolic
disorders
Methyl mercury
Tetracycline
Therapeutic radiation
Thalidomide
TORCH infections
Vitamin A
Accutane
Ace inhibitors
Alcohol
Androgens
Anticonvulsants (Dilantin,
valproate, carbamazepine)
Anticoagulants (warfarin)
Antithyroid meds (PTU,
radioisotopes)
Cancer chemotherapeutic
agents

4. Need 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

5. Teratology Information Services (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

6. What Are Teratology Information Services (TIS’ s)?
TERATOLOGY INFORMATION SERVICES OR PREGNANCY RISK LINES
Service – Toll-free phone consultation to patients or health care providers about exposures during pregnancy
Education – to public and academic groups, including medical, nursing, genetic counseling, pharmacy and others
Research – collaborative projects looking at outcomes of exposures to specific agents

7. Developing a Risk Assessment
Questions:
Timing
Dose
Family, medical and pregnancy history
Other exposures
Literature review

8. Teratology Information in a Product Label
Percentage of
Labeled Drugs
FDA Pregnancy Categories
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%
No 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 %
therapy may outweigh risks.
Category X: Animal studies or human findings have demonstrated %
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.

9. Use of FDA Pregnancy Categories
Assigned prior to release of a drug and rarely changed despite new data
Often assigned on the basis of animal studies
Do not differentiate between different pregnancy situations
Misinterpretation of risk - incorrectly implies dichotomy of risk or gradation of risk

10. Examples of Problems With FDA Categories
SSRI’s – category C – no evidence of increased incidence of birth defects but growing concern about neonatal adaptation
Oral contraceptives – category X – no increase in birth defects but should not be used in pregnancy

11. Providing a Risk Assessment
Collection of data on specific agent
Interpretation of data based on intake information
Elicit callers’ knowledge and source
Discuss 3-5% background risk
Review risk vs. benefit

12. OTIS Members in the Mountain States
ARIZONA
UTAH
TEXAS

13. Utah - Pregnancy Riskline
Established in 1984
Receives nearly 10,000 calls each year or

14. Texas Teratogen Information Service
Established in 1991
State funded
Receives 1,000 calls annually

15. Arizona Pregnancy Riskline
Established in 1988
State funding was obtained in 1999
Receives 2,500 calls annually
Serves as the referral number for states which do not have services – funded by the CDC

16. Organization of Teratology
Information Services
National Phone Number:
(866) 626-OTIS
(866)