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Statin drugs and breastfeeding

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  • Statin drugs and breastfeeding

    I have a 5 week old boy who is exclusively breastfed. I also suffer from EXTREME high cholesterol and my levels are so high at the moment that my cardiac risk is off the charts.
    My GP wants me to stop breastfeeding and resume Rosuvastatin use (Crestor) and my Cardiologist said I could breastfeed for a few months then resume Crestor.
    I have been told by a pharmacologist here in Australia that the risk of passing through to the breast milk is so small and that I could in fact take the Crestor and keep breastfeeding (if I replace breastfeeding with a bottle up to 6 hours after I take the medication).

    I'm not sure if the latter piece of advice is too risky to babe. I have a desire to breastfeed for as long as possible - however I don't want to risk my own health, nor the health of my babe.

    Does anyone have any advice?

  • #2

    Unfortunately we have no data on any of the Statins as to their transfer into human milk. I think it will be low. That said, I doubt that the levels in breastmilk will be clinically high enough to alter an infants cholesterol levels.

    My advice would be to go ahead and use it, but FIRST do a plasma cholesterol on your infant before your start the drug, and then follow up and do another at 1 month after starting the Statin (Crestor). If no change, then obviously no problem.

    If you decide to do this, please let me know the outcome.

    Tom Hale Ph.D.


    • #3
      Thank you Dr Hale.

      If I were to do this, am I putting my newborn under any risk of damage to his liver? One of the side effects of the drug is liver damage, joint pain etc

      Also - do I need to "pump and dump" after I take the meds? I believe it has a 14hr half life?

      Or just carry on breastfeeding as normal?


      • #4

        I do not know if you are putting your newborn at risk of liver damage. I think the risk is minimal, but I don't know this for sure. Remember, all the risks and side effects you see occur rather rarely, and ONLY in patients who receive these doses directly. I anticipate that milk levels will be exceedingly low, but without studies, I can't adequately advise you. Sorry.

        Lastly, this product reaches a peak at about 2-3 hours. It has a really long half-life so you would be unable to avoid exposure by interrupting breastfeeding.

        If you decide to take the med and breastfeed, just do a plasma cholesterol on your infant at 30 days. If you do this, please report the results to me directly.

        Tom Hale Ph.D.


        • #5
          Thanks Dr Hale.

          If I do decide to take the drugs and breastfeed I will let you know the outcome. At this point in time it's still a scary thought and it feels quite risky. I guess I have to weigh up the risks against switching to formula feeding.

          It's a shame there are no real studies available.


          • #6

            Remember, human milk has a lot of cholesterol. Infant formula has zero cholesterol.

            Tom Hale


            • #7
              breastfeeding and high cholesterol

              Dear Dr Hale
              I am breastfeeding an 8months old baby, I would like to breastfeed him until he is 2y or until he wants to stop.
              I have a history of high cholesterol and before pregnancy I've been treated with atorvastatine 20mg and ezet. I checked my levels now and have HDL:50mg/dL and LDL: 292 mg/dL. My endocrinologist suggest I breastfeed until my baby is 1y and then stops to restart the treatment.
              My questions are: would it be too risky for me to continue without treatment for another year? can I have some medication (for example atorvastatine) with no risk for the baby? (note: I work during the day so I could take the pill when I go to work and then he would not have breastmilk until 9 hours after that)
              Thanks a lot for your advise, kind regards


              • #8

                We simply have no data on any of these statin drugs in breastfeeding mothers and their infants. In reality, I doubt simvastatin or even atorvastatin pose much risk to a breastfeeding infant, but I can't prove this right now. I hope to have some data later this year. In your case with such high LDL, I'd probably go ahead and use simvastatin and have your pediatrician check your infants cholesterol levels after a month or so. I'll bet they are normal.

                Tom Hale Ph.d.


                • #9
                  Statin use and breastfeeding

                  I'm in the EXACT same position than Rebekah (post on 10 Oct 2011). Is there any chance that their is new information available that would alter your response to her enquiry? I got a similar response from a South African expert in the field, however I'm hoping that there might be a more concrete answer to the problem I'm facing?

                  Thank you


                  • #10
                    Sorry ladies, but we do not have any data on the STATIN drugs as of yet. I'm starting a clinical research project in the next few weeks, and will be recruiting patients for this study. But this data will take some time to finish.

                    Tom Hale Ph.D.


                    • #11
                      Dear Dr. Hale,

                      I am breastfeeding my 2-year-old daughter only once (at night before she sleeps), and expressing milk once during the day. My Dr. says that I need to get back on Zocor, but she doesn't have enough information concerning the effects of the statin on my daughter. Would the medication pose any risk on my her in any way? Thanks.


                      • #12
                        Dear Mommy,

                        Simvastatin (Zocor) reduces blood cholesterol levels. Others in this family are known to be secreted into human and animal milk, but no data are available on simvastatin. It is likely that milk levels will be low because less than 5% of simvastatin reaches the blood, most being removed by first-pass metabolism in the liver (removed extensively from the blood by the liver). Cholesterol and other products of cholesterol biosynthesis are essential components for fetal and neonatal development, therefore, in young children especially, there is potential for neurodevelopmental adverse effects. Since your daughter is older and receiving smaller amounts of breastmilk the risk would be low, but we can not say there is no risk. You may also discuss this information with your pediatrician. If you have further questions, call the InfantRisk Center at 806-352-2519. We are open Monday through Friday, 8 to 5, CDT.
                        Dr. Hale is starting a clinical research project for STATINS in the next few weeks, and will be recruiting patients for this study. But this data will take some time to finish.

                        Cindy Pride, MSN, CPNP
                        TTUSHC InfantRisk Center
                        Last edited by cpride; 08-23-2013, 05:49 PM.


                        • #13
                          Thank you Cindy. I have decided to take Zocor at night after my (2-year-old) daughter nurses (since she only breastfeeds once a day now). Would it be helpful if I pump and dump the next morning and/or during the day to remove any possible residues from the milk before I nurse her again the following night?


                          • #14
                            Hi Dr. Hale and admins.

                            I am curious if there have been any updates to this study?


                            • #15

                              I ran into some problems with analyzing the atorvastatin, etc. Seems they are rapidly metabolized to other active metabolites and I don't think my mass spectrometer is sensitive enough to measure all these metabolites. So, I've closed the study until I can find someone that can help with the analysis. In this business, everything depends on being able to 'measure' the drug. Sometimes its infinitely difficult to do so. That's where I'm at right now.

                              I'm going to contact the pharmaceutical companies to see if I can get their assistance in measuring these incredibly low levels of metabolites.

                              Sorry, but at this time we can't estimate how much of the various statins enter milk. I think it is low, but that's all I can provide.

                              Tom Hale Ph.D.