Indexed with PubMed and Science Citation Index (E) 
Users online: 3077 
     Home | Feedback | Login 
About Current Issue Archive Ahead of print Search Instructions Online Submission Subscribe What's New Contact  
  Navigate here 
   Next article
   Previous article 
   Table of Contents
 Resource links
   Similar in PUBMED
    Search Pubmed for
    Search in Google Scholar for
   Article in PDF (468 KB)
   Citation Manager
   Access Statistics
   Reader Comments
   Email Alert *
   Add to My List *
* Registration required (free)  

  In this article

 Article Access Statistics
    PDF Downloaded261    
    Comments [Add]    

Recommend this journal

Year : 2004  |  Volume : 70  |  Issue : 3  |  Page : 190-193

Safety of dermatologic agents in lactation

Department of Dermatology, Seth GS Medical College and KEM Hospital, Mumbai, India

Correspondence Address:
Department of Dermatology, Seth GS Medical College & KEM Hospital, A. Donde Marg, Parel, Mumbai - 400012, India
[email protected]

How to cite this article:
Pande S, Nischal K C, Mahajan S. Safety of dermatologic agents in lactation. Indian J Dermatol Venereol Leprol 2004;70:190-3

How to cite this URL:
Pande S, Nischal K C, Mahajan S. Safety of dermatologic agents in lactation. Indian J Dermatol Venereol Leprol [serial online] 2004 [cited 2021 Jan 24];70:190-3. Available from:

   Introduction Top

Many mothers are required to use drugs during breastfeeding. Though most medications do pass into breast milk, it is almost always in an amount less than one percent of the adult dose.[1] Although very few medications are contraindicated for use during lactation, it is wise to be cautious.

The volume of milk ingested by infants is commonly estimated as 0.15 L/kg/day. An arbitrary cut-off of 10% of weight adjusted infant dose has been selected as a guide to the safe use of drugs during lactation. Drugs with more than 10% of weight-adjusted infant dose in the breast milk should be avoided [Table - 1]. For drugs with greater inherent toxicity, such as cytotoxic agents, ergotamine, gold salts, immunosuppressives and isotretinoin, the cut-off of 10% is too high and breastfeeding is contraindicated.

As a general rule, maternal use of topical preparations carries less risk to a breastfed infant than systemically administered drugs due to lower maternal concentrations.

Apart from the dose received via breast milk, the following factors need to be considered while determining the safety of the drugs during lactation:

1. Transfer of drugs into breast milk is influenced by protein binding, lipid solubility and ionization.[2] Nearly all drugs transfer into breast milk to some extent. Drug transfer from maternal plasma to milk is, with rare exceptions, by passive diffusion across biological membranes. Transfer is greatest in the presence of low maternal plasma protein binding and high lipid solubility. In addition, milk is slightly more acidic than plasma (the pH of milk is approximately 7.2 and that of plasma is 7.4), allowing weakly basic drugs to transfer more readily into breast milk. The milk composition varies within and between feeds and this may also affect the transfer of drugs into breast milk. For example, hind milk contains considerably more fat than foremilk and may concentrate fat-soluble drugs.
2. Infants have lower drug clearance than adults.[2] Drug clearance in an infant is a particularly important consideration and premature infants have a severely limited ability to clear drugs.
3. Minimal drug exposure reduces the risk to the breastfed infant.[2] In general, if the infant dose as a percentage of the maternal dose (corrected for weight) is close to 1%, the drug can be considered safe regardless of the infant age. For drugs where the weight-adjusted dose is closer to 10%, the infant clearance should also be taken into account.

Safety assessment of some the drugs frequently used in dermatology is presented in [Table - 2], [Table - 3], [Table - 4], [Table - 5].

Some of the commonly used drugs that are secreted in breast milk or affect breastfeeding along with the precautions to be taken if the drug is continued are tabulated in [Table - 6].

The following principles should be followed when prescribing for breastfeeding mothers:[3]
  • Avoid unnecessary drug use and limit use of even over-the-counter (OTC) products and seek advice for their suitability.
  • Assess the benefit/risk ratio for both mother and infant.
  • Avoid the use of drugs known to cause serious toxicity in adults or children.
  • Drugs licensed for use in infants do not generally pose a hazard.
  • Neonates (and particularly premature infants) are at greater risk from exposure to drugs via breast milk, because of immature excretory functions.
  • Choose a regimen and route of administration which transmits the minimum amount of drug to the infant.
  • Avoid long-acting preparations.
  • Multiple drug regimens may pose an increased risk, especially when adverse effects such as drowsiness are additive.
  • Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms.


   References Top

1.Hale, T. Medications and Mother's Milk 2000, Pharmasoft Publishing, Austin 278-80.  Back to cited text no. 1    
2.Drug safety in lactation Website: May 2001 Prescriber Update No.21:10-23 Last accessed: 17/03/04  Back to cited text no. 2    
3.Breastfeeding mothers and medicines - general guidance In: UK Drugs in Lactation Advisory Service. Last accessed: 06/26/2004  Back to cited text no. 3    
4.Breastfeeding mothers and maternal medication. lactation,drug+safety&hl=en&ie=UTF-8 Last accessed: 06/26/2004.  Back to cited text no. 4    
5.Drugs in Pregnancy and breastfeeding. Created: 11/17/2000. Last Update: 11/30/2002 Last accessed: 06/26/2004.  Back to cited text no. 5    
6.Mutalik N, Salvi V. Drugs in pregnancy. In: Salvi V editors. Medical and surgical disorders in pregnancy. New Delhi, Jaypee brothers medical publishers (P) Ltd. 337-413.  Back to cited text no. 6    
7.Drug information Revised: 06/15/1999, Last accessed: 06/26/2004.  Back to cited text no. 7    
8.Drug information Revised: 9/11/2002. Last accessed: 06/26/2004.  Back to cited text no. 8    
9.Drug information Revised: 03/17/1994. Last accessed: 06/26/2004.  Back to cited text no. 9    
10.Drug information Revised: 02/23/1993. Last accessed 06/19/2004.  Back to cited text no. 10    
11.Gabay MP. Galactogogues: Medications that induce lactation J Hum Lact 2002;18:274-9.  Back to cited text no. 11    
12.Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human breast milk. Pediatrics 1994;93:137-50.  Back to cited text no. 12    


Print this article  Email this article
Previous article Next article


Online since 15th March '04
Published by Wolters Kluwer - Medknow