Transcript TERATOLOGY INFORMATION SERVICES

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
•Accutane
•Ace inhibitors
•Alcohol
•Androgens
•Anticonvulsants (Dilantin,
valproate, carbamazepine)
•Anticoagulants (warfarin)
•Antithyroid meds (PTU,
radioisotopes)
•Cancer chemotherapeutic
agents
•Cigarettes
•Cocaine
•Hyperthermia
•Lithium
•Maternal metabolic
disorders
•Methyl mercury
•Tetracycline
•Therapeutic radiation
•Thalidomide
•TORCH infections
•Vitamin A
Need for Teratology Information
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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)
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Comprehensive multidisciplinary resources for up-todate, authoritative information on reproductive effects of
exposures during pregnancy
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Access to expertise in teratology, dysmorphology,
toxicology, pharmacology, epidemiology, clinical genetics,
infectious diseases, obstetric / maternal fetal medicine,
radiation biology, occupational and environmental health
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Most are located at major medical universities or
affiliated with state public health departments
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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
FDA Pregnancy Categories
Percentage of
Labeled Drugs
• Category A: Controlled studies in human show no risk
• Category B: Animal Studies show no risk but no controlled studies
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
or
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.
< 1%
20%
65%
7%
7%
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