Page 289 - ATP-P 11th Ed

PREGNANCY CATEGORY A
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in
the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

PREGNANCY CATEGORY B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there
are no adequate and well-controlled studies in pregnant women OR Animal studies
have shown an adverse effect, but adequate and well-controlled studies in pregnant
women have failed to demonstrate a risk to the fetus in any trimester.

PREGNANCY CATEGORY C
Animal reproduction studies have shown an adverse effect on the fetus and there
are no adequate and well-controlled studies in humans, but potential benefits may
warrant use of the drug in pregnant women despite potential risks.

PREGNANCY CATEGORY D SECTION 3
There is positive evidence of human fetal risk based on adverse reaction data from
investigational or marketing experience or studies in humans, but potential benefits
may warrant use of the drug in pregnant women despite potential risks.

PREGNANCY CATEGORY X
Studies in animals or humans have demonstrated fetal abnormalities and/or there is
positive evidence of human fetal risk based on adverse reaction data from investiga-
tional or marketing experience, and the risks involved in use of the drug in pregnant
women clearly outweigh potential benefits.

➤ Medications with grounding requirements for personnel on flight status
have been added. In some cases, the recommendation for grounding has been
made based on the underlying medical condition and not specifically on the medi-
cation. Whenever possible consult a Flight Surgeon or an Aeromedical Physician
Assistant prior to prescribing medications to personnel on flight status. Consult
your unit medical officer for any unit specific protocols.
➤ REMINDER: After personnel on flight status have been grounded, they need
clearance from a Flight Surgeon or an Aeromedical Physician Assistant to return
to flying status.

ATP-P Handbook 11th Edition 279