Logged in as | Logout

Multilingual Support:

Concerns

Pregnancy, breastfeeding and drugs used in dentistry

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

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.

OK