Is Efavirenz Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Efavirenz? Is Efavirenz safe for nursing mother and child? Does Efavirenz extracts into breast milk? Does Efavirenz has any long term or short term side effects on infants? Can Efavirenz influence milk supply or can Efavirenz decrease milk supply in lactating mothers?

• DrLact safety Score for Efavirenz is 5 out of 8 which is considered Unsafe as per our analyses.
• A safety Score of 5 indicates that usage of Efavirenz may cause serious side effects in breastfed baby.
• Our study of different scientific research indicates that Efavirenz may cause moderate to high side effects or may affect milk supply in lactating mother.
• Our suggestion is to use safer alternate options rather than using Efavirenz .
• It is recommended to evaluate the advantage of not breastfeeding while using Efavirenz Vs not using Efavirenz And continue breastfeeding.
• While using Efavirenz Its must to monitor child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
• Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Anti-HIV drug. There is not experience on children younger than 3 years old. Mothers must be adviced that transmission of HIV infection through breastfeeding has been documented.

In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. Published experience with efavirenz during breastfeeding is limited. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, World Health Organization guidelines recommend that all women with an HIV infection who are pregnant or breastfeeding should be maintained on antiretroviral therapy for at least the duration of risk for mother-to-child transmission. Mothers should exclusively breastfeed their infants for the first 6 months of life; breastfeeding with complementary feeding should continue through at least 12 months of life up to 24 months of life.[1] The first choice regimen for nursing mothers is tenofovir, efavirenz and either lamivudine or emtricitabine. If these drugs are unavailable, alternative regimens include: 1) zidovudine, lamivudine and efavirenz; 2) zidovudine, lamivudine and nevirapine; or 3) tenofovir, nevirapine and either lamivudine or emtricitabine. Exclusively breastfed infants should also receive 6 weeks of prophylaxis with nevirapine.[2][3] Treatment of mothers of HIV+ mothers with efavirenz as part of Option B+ therapy does not appear to affect growth of their HIV-negative breastfed infants.

Thirteen mothers nursed their infants while they were taking efavirenz 600 mg daily, lamivudine 150 mg and zidovudine 300 mg daily (n = 12) or stavudine 60 mg daily (n = 1) . No adverse reactions were reported in the infants after 6 months of breastfeeding, none had developed HIV infection and all were developing normally.[4] An unblinded study in Uganda compared the outcomes of breastfed infants and their HIV-positive mothers who were randomized to receive antiretrovial therapy that was based either on efavirenz 600 mg once daily or lopinavir 400 mg plus ritonavir 100 mg twice daily during breastfeeding. All mothers received lamivudine 150 mg, zidovudine 300 mg twice daily and trimethoprim-sulfamethoxazole once daily. All infants received prophylaxis with either zidovudine for 1 week or nevirapine for 6 weeks, plus trimethoprim-sulfamethoxazole from 6 weeks of age to 6 weeks after weaning. Almost all of the infants were exclusively breastfed until 6 months of age and about 73% were partially breastfed until 12 months of age. There was no statistical difference in hospitalizations or adverse events including anemia, neutropenia or deaths among infants in the two groups.[10] A prospective cohort study compared the growth and development of infants of HIV-negative mothers and infants of HIV-positive mothers taking efavirenz and tenofovir as part of Option B+ HIV treatment. Infants were followed up to 12 months of age. No differences in the groups was found in any growth parameters.[11] Among 32 breastfed (extent not stated) infants whose mothers were taking efavirenz 600 mg daily as part of a multi-drug treatment for HIV infection, no adverse effects were noted by investigators or reported by mothers at 1, 3 and 6 months of age.[8]

Gynecomastia has been reported among men and at least one woman receiving efavirenz therapy.[12][13] Efavirenz appears to be much more likely to cause gynecomastia than other antiretroviral agents. Gynecomastia is unilateral initially, but can progress to bilateral. Spontaneous resolution usually occurred within one year, even with continuation of the regimen. The relevance of these findings to nursing mothers is not known. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.