Medications and Pregnancy
Pregnancy, breastfeeding and drugs used in dentistry#
| FDA Category | Safe during pregnancy? | Safe during breastfeeding? | |
| Analgesics | |||
| Acetaminophen | B | Yes | Yes |
| Aspirin | C/D | Avoid | Avoid (>100 mg associated with platelet dysfynction and Reye’s syndrome) |
| Codeine | C | Use with caution | Yes |
| Glucocorticoids | C | Avoid, except when needed for emergency care | Yes |
| Hydrocodone | C | Use with caution | Use with caution |
| Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) | C/D | Avoid in 3rd trimester | Yes |
| Oxycodone | B | Use with caution | Yes |
| Propoxyphene | B | Use with caution | Use with caution |
| Antibiotics | |||
| Amoxicillin | B | Yes | Yes |
| Cephalexin | B | Yes | Yes |
| Chlorhexidine (topical) | B | Yes | Yes |
| Clindamycin | B | Yes | Yes |
| Clotrimazole (topical) | B | Yes | Yes |
| Doxycycline | D | Avoid | Avoid |
| Erythromycin | B | Yes | Caution |
| Fluconazole | C/D | Yes (single dose regimens) | Yes |
| Metronidazole | B | Avoid | Avoid |
| Nystatin | C | Yes | Yes |
| Penicillin | B | Yes | Yes |
| Terconazole (topical) | B | Yes | Yes |
| Tetracycline | D | Avoid | Avoid |
| Local anesthetics | |||
| Articaine | C | Use with caution | Use with caution |
| Bupivacaine | C | Use with caution | Yes |
| Etidocaine | B | Yes | Yes |
| Lidocaine (+/- epinephrine) | B | Yes | Yes |
| Mepivacaine (+/- levonordefrin) | C | Use with caution | Yes |
| Prilocaine | B | Yes | Yes |
| Topical anesthetics | |||
| Benzocaine | C | Avoid | Avoid |
| Dyclonine | C | Yes | Yes |
| Lidocaine | B | Yes | Yes |
| Tetracaine | C | Yes | Yes |
| Sedatives | |||
| Benzodiazepine | D/X | Avoid | Avoid |
| Zelaplon | C | Use with caution | Use with caution |
| Zolpidem | C | Use with caution | Yes |
| Other emergency medications | |||
| Albuterol | C | Steroid and β2-agonist inhalers are safe | Avoid |
| Diphenhydramine | B | Yes | Yes |
| Epinephrine | C | Use with caution | Caution |
| Flumazenil | C | Use with caution | Caution |
| Naloxone | C | Use with caution | Caution |
| Nitroglycerine | C | 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.