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High dose prednisone and Imuran

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  • High dose prednisone and Imuran

    Dr Hale,
    I have a patient in her early 30's, in otherwise perfect health, breastfeeding her 6 month old infant. She was recently hospitalized and diagnosed with an auto-immune hepatitis. Initially she was told she would have to stop nursing due to her medications. After some research, she was told that while she is on her high dose prednisone (60mg daily) she could continue to nurse, if the baby were subjected to weekly blood monitoring for glucose levels but she would need to stop nursing completely when she started taking Imuran.

    Can you provide her with any information that will suggest that the benefits of nursing will outweigh the risks of the medications? She would really like to continue nursing if possible, but is concerned that the risks of taking an L3 medication outweigh the benefits of breastmilk. Furthermore, do you believe it is necessary for the baby to be monitored for glucose levels while she is taking prednisone? She would like to avoid that as well.

    At the very least, she would like to be able to continue nursing her son at least once per day. If there is continued risk to nursing while taking these medications, do you believe it would be possible for her to nurse once per day outside of the half life of the medication?

    Thank you so very much for any reply.

  • #2

    The discussion below really depends on just how much the mom is breastfeeding and the volume of breastmilk she is delivering to the infant. If low, then the risk is reduced. If mom is delivering a high volume (700 cc), then the risk is slightly higher.

    As for a relatively high dose of prednisone (60 mg/day), only around 1.8% or so is going to transfer to the infant. I do not think this is high enough to cause clinical effects in the infant. But an occasional blood glucose is not a bad idea, but wouldn't a finger stick work just as well. Also over time you should closely monitor linear growth rate in the infant just to be sure. Below are a review of the studies of prednisone in my book.

    As for Azathioprine(Imuran), we have a bunch of studies on this drug and less than 0.26% of the maternal dose is transferred to the infant. This is far too low to impact the infant.


    Tom Hale PhD.

    ======From MMM 2010 =================================================

    Small amounts of most corticosteroids are secreted into breastmilk. Following a 10 mg oral dose of prednisone, peak milk levels of prednisolone and prednisone were 1.6 µg/L and 2.67 µg/L, respectively.[1] In a group of 10 women who received 10-80 mg/d prednisolone, the milk levels were only 5-25% of the maternal serum levels.[2]

    In one patient who received 80 mg/day prednisolone, the Cmax at 1 hour was 317 µg/L. The AUC average milk concentration in this mother was 156 µg/L over 6 hours.[2] This is significantly less than 2% of the weight-normalized maternal dose. Because this last estimate was only determined over 6 hours and this dose was administered once each 24 hours, the total daily estimate would be much less than the 2% estimate.

    In another study of a single patient who received 120 mg prednisone/day, the total combined steroid levels (prednisone + prednisolone) peaked at 2 hours.[3] The peak level of combined steroid was 627 µg/L. Assuming the infant received 120 mL of milk every 4 hours, the total possible ingestion would only be 47 µg/day.

    In a group of 7 women who received radioactive labeled prednisolone 5 mg, the total recovery per liter of milk during the 48 hours after the dose was 0.14%.[4]

    In small doses, most steroids are certainly not contraindicated in nursing mothers. Whenever possible use low-dose alternatives such as aerosols or inhalers. Following administration, wait at least 4 hours if possible prior to feeding infant to reduce exposure. With high doses (>40 mg/day), particularly for long periods, steroids could potentially produce problems in infant growth and development, although we have absolutely no data in this area, or which doses would pose problems. Brief applications of high dose steroids are probably not contraindicated as the overall exposure is low. With prolonged high dose therapy, the infant should be closely monitored for growth and development.


    • #3
      Dr Hale,

      Thank you very much for your extremely prompt reply. My patient is taking this information to her pediatrician and is thrilled to know that she can continue nursing.



      • #4
        Hi Dr. Hale,
        I have ulcerative colitis and I was on 20 mg of prednisone and the doctor increased my imuran (azathioprine) from 75-100 mg. I was just told to start to taper the prednisone. I am concerned one or both of these medications are affecting my nursing son, though the doctors do not seem concerned. He is a peanut, only in the 5-10 percentile for height and weight. He is happy and healthy, but I feel very guilty for being sick. I want him to have what is best and I was told breastfeeding is what is/was best. He started off in the 50 percentile, but dropped down around 6 months when we started introducing solid foods, which I was told is normal. I try to wait the full 4 hours before nursing him, some days I have to nurse him a little early if he's unconsolable, but for the most part we get the full 4 hours. Are these medications truly okay for him?
        Last edited by kwjkitty; 06-21-2013, 11:16 AM.


        • #5

          The data on azathioprine is pretty good and suggests very very little of it gets to your infant via milk. I'd discuss your son's change in percentile with your pediatrician, he/she will need to get to the root of this, such as doing a bone age scan. I doubt it is azathioprine, but prolonged exposure to higher doses of prednisone may cause low stature, but not necessarily low weight.

          So I think your pedi is the best person to speak with about this problem. There are so many other things that can cause low percentiles, that its hard for someone remote to help with this.

          Tom Hale Ph.d.


          • #6
            I am 36 wks pregnant and on 100mg Imuran daily for U.C. I have been in remission for 8 yrs. There have been no complications with my pregnancy. I am getting very mixed advice from my GI, OB and pediatrician on whether or not I can breastfeed while on Imuran. What is the current recommendation? Also, is pumping and dumping after taking the medication helpful? Does it build-up in the colostrum prenatally? My pediatrician is concerned about the baby receiving a concentrated dose of the medication if given the colostum? Thank you for any information/advice you can give me. Alysia


            • #7
              Dear Asmith78,

              Azathioprine (Imuran) is a powerful immunosuppressive agent that is metabolized to 6-Mercaptopurine (6-MP). The transport of 6-mercaptopurine into human milk is apparently quite low. However, this is a strong immunosuppressant and some caution is still recommended if it is used in a breastfeeding mother.

              The risks to the infant are probably low. Recent long-term data suggest that the rate of infections in treated groups is no different from non-treated controls. We still advise the pediatrician to monitor the infant closely for signs of immunosuppression, leukopenia, thrombocytopenia, hepatotoxicity, pancreatitis, and other symptoms of 6-mercaptopurine exposure.

              This medication has a half life of 0.6 hours, in approximately 6 half lives (3.5-4 hours) most of the medication will be out of your system, you can avoid breastfeeding during that time frame if possible to limit transmission to the baby.

              Generally, transfer of medications from the mum to the baby in utero is greater than through breastmilk.

              Hope this helps!! call us at the InfantRisk Center on 806-352-2519 if you have more questions.

              Tassneem Abdel Karim, MD
              InfantRisk Center