Minocycline (Amzeeq®)

Pregnancy

No adverse effects of topical minocycline were observed in animal studies to date. Minocycline crosses the placenta when minocycline is taken orally. When applied topically, only a small fraction of minocycline enters the bloodstream.

If an antibiotic is needed during pregnancy, topical minocycline may be considered, however the amount of minocycline that enters the bloodstream is dependent on how long it is used and how large an area of skin to which it is applied. Therefore, it is important to consult your physician regarding the use of topical minocycline during pregnancy.  

Category: B

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).

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.

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.

Category D

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.

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 investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: yes (after oral dosing or intravenous dosing); unknown after topical use. 

Minocycline may cause adverse effects related to the infant’s intestines when used orally while breastfeeding, such as diarrhea, diaper rash, thrush, or rarely bloody stool. If excreted into breast milk, minocycline may cause discoloration of teeth and slow down the growth of bones. These adverse effects are however unlikely when topical minocycline is used. The risk of diarrhea may be increased when minocycline is applied to the nipple area. Do not apply minocycline to the nipple area and make sure the infant’s skin does not come into contact with the areas of skin that have been treated with minocycline. Also, only apply water-based cream, gel or liquids to the breast to avoid possible exposure to mineral paraffins via licking. 

If an antibiotic is needed during breastfeeding, topical minocycline may be considered, however, the amount of minocycline that enters the bloodstream is dependent on how long it is used and how large an area of skin to which it is applied. Therefore, it is important to consult your physician regarding the use of topical minocycline during breastfeeding.  

If you are breastfeeding, speak with your physician before you use minocycline. Weigh the benefits against potential risks before using minocycline while breastfeeding