TERATOLOGY INFORMATION SERVICES

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

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

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

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

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

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

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 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 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

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

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

OTIS Members in the Mountain States ARIZONA UTAH TEXAS

Utah - Pregnancy Riskline Established in 1984 Receives nearly 10,000 calls each year 328-2229 or 1-800-822-2229

Texas Teratogen Information Service Established in 1991 State funded Receives 1,000 calls annually 1-800-733-4727

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 1-888-285-3410

Organization of Teratology Information Services www.otispregnancy.org National Phone Number: (866) 626-OTIS (866) 626-6847