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Concerns

Pregnancy, breastfeeding and drugs used in dentistry

Explanation of FDA categories

New proposed rule 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
Codeine B Use with caution Yes
Hydrocodone B Use with caution ?
Ibuprofen C/D Avoid in 3rd trimester Yes
Oxycodone B Use with caution Yes
Propoxyphene C Use with caution Yes
Antibiotics
Aminoglycosides D Avoid ?
Cephalosporine B Yes Yes
Clindamycin B Yes yes
Ciprofloxacin C Avoid ?
Erythromycin B Yes Yes
Metronidazole B Avoid Avoid
Penicillin B Yes Yes
Tetracycline D Avoid Avoid
Local anesthetics
Bupivacaine C Use with caution Yes
Etidocaine B Yes Yes
Lidocaine B Yes Yes
Mepivacaine C Use with caution Yes
Prilocaine B Yes Yes
Miscellaneous
Barbiturates D Avoid ?
Benzodiazepine D/X Avoid ?
Ergotamine X Avoid ?
Fluconazole C/D Avoid ?
Glucocorticosteroids C Avoid ?

Explanation of FDA categories

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