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  • Ozurdex treat CRVO and breastfeeding

    Greeting from Ning Shao in Beijing,China. I am a mother of two months baby. Last week I was diagnosed as central retinal vein occlusion(CRVO) by the ophthalmologist and I have to recieve the treatment through OZURDEX (dexamethasone intravitreal implant) one week later. My ophthalmologist said he think it's safe to continune the breastfeeding during my treatment. But it's stated in the OZURDEX product labeling "8.3 Nursing Mothers:It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman".

    These days I am desperately sad and could not sleep day and night. I am not sure whether it's really safe for my baby to continue breastfeeding if I use the medication. Afterall OZURDEX is dexamethasone and it will be sustained-released, lasted for over 3 months as it is stated in the product labeling "12.3 Pharmacokinetics Plasma concentrations were obtained from 21 patients in two 6 month tudies prior to dosing and on Days 7, 30, 60, and 90 following the intravitreal implant containing 0.35 mg or 0.7 mg dexamethasone. In both studies, the majority of plasma dexamethasone concentrations were below the lower limit of uantitation (LLOQ = 50 pg/mL). Plasma dexamethasone concentrations from 10 of 73 samples in the 0.7 mg dose group and from 2 of 42 samples in the 0.35 mg dose group were above the LLOQ, ranging from 52 pg/mL to 94 pg/mL. The highest plasma concentration value of 94 pg/mL was observed in one subject from the 0.7 mg group. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid,retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were observed."

    I woud be much appreciated if you could give me further advise on the safety of OZURDEX used in breastfeeding mother. Look forward to you prompt response.
    Last edited by Nicola_shao; 02-14-2013, 10:07 AM.

  • #2
    Dear Nicola-shao,

    Dexamethasone is not likely to enter breastmilk in clinically relevant amounts unless used in high doses over prolonged periods. The studies you included indicate that minimal levels of the drug are present in the blood plasma; therefore, would be expected to be minimal in breastmilk as well. Based on these studies, dexamethasone should be compatible with breastfeeding. If you are concerned, you may have your pediatrician monitor your infant's growth to make sure your infant is growing appropriately. Let us know if you have further questions. You may also call the InfantRisk Center at 806-352-2519.

    Sincerely,
    Cindy Pride, MSN, CPNP
    TTUHSC InfantRisk Center

    Comment


    • #3
      Dear Cindy,
      I'm so glad to recieve your feedback which means a lot to me. These days I searched a lot of relavant information through Internet, I would like to provide you below link: http://www.allergan.com/assets/pdf/ozurdex_pi.pdf. I would much appreciate if you could help me to further check the safety of OZURDEX used in breastfeeding through the product labeling and other more resouces if you have.

      Thank you so much for your kindly help. Look forward to hearing from you.

      Best regards,
      Nicola_shao

      Comment


      • #4
        Dear Nicola_shao,

        The pharmacokinetic information is still the same in the link you sent. The medication in the blood plasma is what is available to enter the breastmilk. The manufacturer's studies show the blood plasma levels in picograms (pg) which is very small. It takes 1,000,000 picograms to equal 1 microgram. We know that if the amount in the blood plasma is small, then the amount of the medication that would enter breastmilk would be expected to be small. Hope this information helps.

        Sincerely,
        Cindy Pride, MSN, CPNP
        TTUHSC InfantRisk Center

        Comment


        • #5
          Dear Cindy,

          Thank you so much for your kindly reply. Based on your information I have decieded to breastfeeding my baby during night, during daytime I will give him the milk. I hope the risk will be more miminal by this way, I am not sure this is the best decision or not. Anyway, you do help me a lot, I am very greatful for your kindly help during the most difficult situation in my life.

          I do hope you could continue send me the further revlant information if it's available to you.

          Thank you so much!
          Best regards,
          Nicola_shao

          Comment


          • #6
            Dear Cindy,

            I'm writing to for your help again. My ophthalmologist prescribed TOBREX(Tobramycin Eye Drops) for me, 2 drops per time, 4 times per day for six days. I would like to know whether I could breastfeeding my baby during the eye drop treament. In the product labeling, it states infant risk could not be rullout. This bothering me a lot these days. I feel sorry for my baby that I could not give him the best care.

            Looking forward to your guidance.

            Thank you so much.
            Best regards,
            Nicola_shao
            Last edited by Nicola_shao; 02-19-2013, 08:52 AM.

            Comment


            • #7
              Dear Nicola_shao,

              Tobramycin breastmilk levels are minimal. Also, tobramycin is not absorbed orally so the small amount that is in your breastmilk would not be expected to produce systemic levels in your infant. We believe tobramycin is compatible with breastfeeding. The product labeling is from the manufacturers drug studies. The drug manufacturers rarely conduct breastmilk studies. The studies are usually done by independent research laboratories. Dr. Hale's book called Medications and Mothers' Milk reflects the breastmilk studies that have been done. He determines infant risk based on the drug kinetics, side effects, and available breastmilk studies.

              Sincerely,
              Cindy Pride, MSN, CPNP
              TTUHSC InfantRisk Center

              Comment


              • #8
                Dear Cindy,
                Thank you so much for your information, the information you provided make me feel much better. I am very grateful for your kindly help.

                I am wondering if you could provide me Dr. Hale’s email address. Be frankly, I am still concerned about the safety of breastfeeding after my Ozurdex treatment, which is really bothering me a lot. I just want to further consult with Dr. Hale. Hopefully you could understand me.

                Thank you so much!
                Best regards,
                Nicola_shao

                Comment


                • #9
                  Dear Nicola_shao,

                  The information previously given was discussed with Dr. Hale prior to publishing, and he thinks the dexamethasone is compatible with breastfeeding due to the kinetic studies. He believes the benefits of breastfeeding outweigh the risks of the medication in your case. You may also discuss your concerns with your pediatrician, but in the end, you have to decide whether to breastfeed or not.

                  Sincerely,
                  Cindy Pride, MSN, CPNP
                  TTUHSC InfantRisk Center

                  Comment


                  • #10
                    Dear Cindy,

                    I am so glad to receive your feedback and I am excited with happy tears to learn that Dr. Hale also give his comments and help on my case that makes me feel more confident and comfortable to make the decision of continuing breastfeeding for my baby.
                    h
                    Actually, I have already consulted with several pediatricians here in Beijing, but they all gave their comments based on the product labeling. I understand them because the most of pediatricians in China really do not have the experience and knowledge about the special case like this. I am so lucky that my friends introduced me Dr. Hale?s book ?Medication and Breastfeeding? and in the end I learned the InfantRisk center. I do think what you are doing is great which help a lot of people like me.

                    Please accept my sincere thanks again and please say thank you to Dr. Hale.

                    Best regards,
                    Nicola_shao

                    Comment

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