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Medications and Pregnancy

Pregnancy, breastfeeding and drugs used in dentistry#

FDA CategorySafe during
pregnancy?
Safe during
breastfeeding?
Analgesics
AcetaminophenBYesYes
AspirinC/DAvoidAvoid
(>100 mg associated with platelet dysfynction and Reye’s syndrome)
CodeineCUse with cautionYes
GlucocorticoidsCAvoid, except when needed for emergency careYes
HydrocodoneCUse with cautionUse with caution
Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs)C/DAvoid in 3rd trimesterYes
OxycodoneBUse with cautionYes
PropoxypheneBUse with cautionUse with caution
Antibiotics
AmoxicillinBYesYes
CephalexinBYesYes
Chlorhexidine (topical)BYesYes
ClindamycinBYesYes
Clotrimazole (topical)BYesYes
DoxycyclineDAvoidAvoid
ErythromycinBYesCaution
FluconazoleC/DYes (single dose regimens)Yes
MetronidazoleBAvoidAvoid
NystatinCYesYes
PenicillinBYesYes
Terconazole (topical)BYesYes
TetracyclineDAvoidAvoid
Local anesthetics
ArticaineCUse with cautionUse with caution
BupivacaineCUse with cautionYes
EtidocaineBYesYes
Lidocaine
(+/- epinephrine)
BYesYes
Mepivacaine
(+/- levonordefrin)
CUse with cautionYes
PrilocaineBYesYes
Topical anesthetics
Benzocaine CAvoid Avoid
DyclonineCYes Yes
LidocaineBYes Yes
TetracaineC Yes Yes
Sedatives
BenzodiazepineD/XAvoidAvoid
ZelaplonCUse with cautionUse with caution
ZolpidemCUse with cautionYes
Other emergency medications
AlbuterolC Steroid and β2-agonist inhalers
are safe
Avoid
DiphenhydramineBYesYes
EpinephrineCUse with cautionCaution
FlumazenilCUse with cautionCaution
NaloxoneC Use with caution Caution
NitroglycerineC Use with caution Caution

Explanation of FDA categories and new proposed rules on pregnancy and lactation labeling#

FDA classification system for drugs’ potential to cause birth defects

A – No fetal harm demonstrated during any trimester

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

B – No controlled studies in women, but no evidence of harm in animal studies during any trimester

C – Adverse effects in animal studies, but no controlled studies in women. Drugs in this category should only be given if the potential benefit justifies the potential risk to the fetus

D – Evidence of harm to the fetus exists. Drugs in this category should only be used in pregnant women in a life-threatening situation, or if safer drugs cannot be used or are ineffective

X – Contraindicated in pregnant women

Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).

New proposed rule on pregnancy and lactation labeling#

Current pregnancy labeling categories may be misleading, as progression through categories A, B to categories C, D, and X are not solely based on risk, but also on a risk to benefit consideration. Thus, drugs in categories C or D may pose risks similar to drugs in category X. In addition, there are no clear guidance regarding frequency, severity, and type of fetal developmental toxicities. The new proposed rule would remove the categories from the labeling of all drug products, and instead use three principal components: a risk summary, clinical considerations, and a data section.


Related Pages#

References/Websites#