Save Little Michael
I am writing to you about our problem at hand. Our son Michael has been on Neocate Junior Unflavored an Amino Acid-Based Medical Food since he was three months old. We are not sure what is wrong with him medically except he has Food Protein Induced Enterocolitis Syndrome. Michael reacts to ANY food. We have trialed: Rice, Peas, carrots, sweet Potato, oatmeal, apples, bananas, Pears, prunes, squash, blueberries, raspberries, apple juice, orange juice, saltine crackers, oyster crackers, rice cookies, rice wafers, croutons, tomato, potato, cheerios, froot loops, green beans, white bread, wheat bread, egg, cucumber, popsicles, Gatorade, chicken, bacon, milk, cheese, noodles, rice noodles, cheez it, corn, hamburger, fruit chews, lollipops, macaroni and cheese, black olives, tea, unfiltered water, Elecare Infant, Elecare Junior, Neocate Infant, Neocate Infant with DHA and ARA, Neocate Junior with Prebiotics, Neocate tropical, Enfamil, Eo28 Splash, French fry, amoxicillin, Benadryl, mylicon, Tylenol, Ibuprofen, Soy formula, goat milk, etc.
His only safe foods were Neocate Infant before SHS International started producing the DHA and ARA (due to soy content) and Neocate Junior Unflavored mixed with nursery water (without added fluoride). Our 3 year old son thinks it’s a treat to eat ice. My son goes through a can of Neocate Junior Unflavored a day to maintain his weight and nutrients. I know this formula better than I know the back of my hand.
When we got our shipment of Neocate in November it has a new label on it, which did not concern me; as I remembered Nutricia making a press release stating that it would have a new looking label but would have no change in ingredients. So the first time he had a new label my husband had made up his mixers the night before. This is our routine we make up water in his bottles and mixers so that it’s easy to travel with. I did not know that he had made them up with New label Neocate. Michael kept refusing his bottles that night, telling me “Mommy bottle ishy, yuck.” I kept telling him the bottles are fine, and that it’s a brand new one. He would only drink an ounce or two out of each bottle. I just figured he wasn’t really hungry. Then the next morning he would only drink 2 ounces out of each bottle. He was becoming very fussy and started to throw up. I called my husband to see if he had possibly gotten into anything the previous day as I was in clinical for my RN.
My husband assured me nothing was wrong and he must just have a stomach bug. Then Michael had diarrhea, and I was sure it was a reaction diaper. I know when my son is reacting to a food because his stool becomes mucous; yellow tinged and had black dots throughout. I called my husband and told him he needed to think through all of yesterday. He said they didn’t go anywhere, and that nobody came over, and that he didn’t even eat his usual lunch in the kitchen as he was not hungry. I wasn’t nice, but I was worried, as I had no idea what was going on. Michael wouldn’t stop crying and screaming, and was refusing his bottles. Thomas assured me he would be home in a few hours and that Michael would be okay. Michael had 6 more diapers filled with diarrhea, awful smelling, yellow, mucous, with blood. When Thomas walked in the door he walked through the kitchen gait to put his lunch box down and went into the garbage to throw out his trash. He held up the can and said “Jen this can is the new label.” He then said “You told me that their ingredients were not changing, just the label so it never crossed my mind to even look.” We sat at the table and marked off one ingredient at a time, to be assured that they were listed the same, same nutritional facts and everything. This was November 16th 2012.
I dumped out all his bottles and got them ready to sanitize. I also washed and sanitized his mixers. Thomas then went and grabbed a can expiring January 20, 2013 and filled his mixers. Michael started to drink his entire bottle, and by the next morning I saw a huge improvement. At this point we thought maybe it was one bad can mislabeled. I thought I was losing my mind. We waited 2 days to try another new label. This was November 19th 2012. With the first bottle we diluted it so that he was only getting 2 ounces of new in his 8 ounce bottle. Then within two hours of that bottle Michael started screaming in pain again holding his belly telling me “Mommy, my tummy hurts.” I immediately dumped that bottle out, threw it in the garbage, and washed and sanitized his mixers. I then called 1-800-365-7354 and spoke to Christine. She told me that the ingredients haven’t changed and that us parents are just concerned because of the new label. But then asked for my lot number and I told her 100332318 can # 002733 manufactured Aug 20, 2012 expiration Feb 16, 2014 timestamp 08:17. She then asked me why I think my son is reacting to it. I explained to her how my sons only source of food is this Neocate Junior Unflavored. And that nothing has changed in our house, and that there is no possible way for our son to get an accidental ingestion of any food. I then began to tell her how we had decided two months prior to stop food trials and give our son a gut rest period. It seemed odd that they wanted to pick up that entire lot the next day, even our opened can. So I let them. They promised they would test and have answers before Thanksgiving. Christine assured me that nothing had changed period. She then told me to try a different lot. We tried one bottle of 100328233 can 003572 manufactured on July 25th 2012 expiration Jan 21 2014 time stamp 1838. That one bottle made him start screaming and yelling at us telling us his “tummy hurt and ishy”. Then the diarrhea came again, as with all of his Neocate New label reactions. I called Christine again and told her the information on that lot. She didn’t want to pick it up as someone else had already complained about that lot.
I got online and posted in some of my groups how we had reacted asking if anyone else had the same issue. And sure thing people were saying the same thing as me, with different diagnosis. Next phone call I made was to the FDA. The person through the FDA took my information and claim and told me they were going to do an investigation as I was not the first call. Then I called Nutricia and let her know that we reacted to another lot # 100337968 can 001676 manufactured Sept 26 2012 expiration March 25 2014 time stamp 07:22.
At this point I said I would never let my son have a new label can until they could tell me what was making my son so ill. We were running out of old label and I knew I couldn’t buy old label through their online site. I got on amazon.com where we have bought the majority of our formula from, it has always saved us around 20 dollars for the four cans. Nutricia made sure to tell me they were doing everything in their power to verify that the formulation has not changed. Ulrike even told me the “glue on the label is even the same.” Then Michael reacted to an old label can lot #100305384 manufactured may 15 2012 expiration November 11 2013 can 04699.
I couldn’t understand what in the world was going on. So I looked it up more and realized that their product Neocate Nutra ingredient changed from corn starch to rice starch in the month of May 2012. So they couldn’t just tell me I am just a concerned parent about the label change, as I pin pointed what had changed in their factory and that they had some old label cans affected as well.
At this point they started talking to me about other forms of nutrition like Tolerex made by Nestle, which produces milk and soy in their facility and has a warning on their label “made in same plant with soy, milk, egg and wheat products. Not for parenteral use. For use only under medical supervision.” They referred us to Vivonex T.E.N., its warning is “Made in same plant with soy, milk, egg, and wheat products. Not for parenteral use. For use only under medical supervision. Not intended for children under 10 years of age unless specified by a physiciam.” These are not an option for us.
When we tried Elecare junior unflavored, we only made it through 6 hours before noticing a reaction. We believe it was the soy oil we reacted to. Neocate infant with DHA and ARA contains 6% soy so this is also not an option. We really have exhausted all avenues, to get us to Neocate Junior Unflavored. And Michael is 100% fine on any old label Neocate Junior Unflavored manufactured before May 2012. Yet the company assures us they “have tested for everything and turned the plant inside out and upside down nothing has changed and that testing came back within reasonable expectations.”
They won’t mention that anything we react to has a pop top with the number 23A or 23 B on it and that anything that is fine says 13A or 13B. Expiration of October 28th (manufactured May 01 2012) they switched that around. They won’t tell me what it means. They also won’t tell me why they smell different, and the new one clumps in our bottles, and changes color as it sits out. Also my son is reacting to this new formula the way he does rice. Nutricia and the FDA claim there is no test for rice protein but that they did test for rice DNA and it came back negative. I don’t know about you, but I am not a biology major and I know that protein and DNA are very different. They also won’t test the product for peptide chains or protein period.
My sons reactions consist of vomiting, severe pain, eczema, reflux, diarrhea (with mucous and sometimes blood), swollen face and wrists, gas, sunken dark eyes, hyper active, then lethargic, twitching, and neurological setbacks. During his reactions there is nothing that I can do to help ease his pain as he reacts to Tylenol, ibuprofen, Benadryl, etc. And his episodes are constant for the first two days and then come and go for about three weeks, they ease up slowly. But he goes from severe diarrhea, to constipation. I allow my son to pinch me because that’s how he tells me he is in that large amount of pain. I cannot even begin to imagine the pain that our child has had to deal with his whole life.
I always knew Michael was sick because he could only tolerate 1 source of nutrition, but I would have never thought that his only source of nutrition would be altered or contaminated in some way. When given these cans after May 2012; I can’t even imagine what would happen to him if he were to have it more than 12 hours. Would he choose to starve to death or would he drink it and get really sick, with dehydration, failure to thrive, hypovolemic shock, kidney injury, all leading to death.
The key to this whole story is Michael is 100% fine on Neocate Junior Unflavored manufactured before May 2012 expiration October 22, 2013 and before. But that anything made May 2012 and after could cause him to die. Also that we are not alone, and I know there has to be more people suffering besides the few families I can find. I don’t want my son to die. Please help us.
Michael had his last bout of problems with a May 01 2012 can, this can threw him into his regular reaction and had a top of 13B. Also he went into a seizure from this can, due to all of the reactions in about a two month time frame, and has been having other issues. I had no choice but to give up school now, so I can be with him at all times.
You can see that we are featured on the http://www.iafflocals20.net/index.cfm?section=1
And http://foodallergyfoundation.org/donate/save_michael and http://www.nbc-2.com/story/20297315/lehigh-family-desp. Our blog is https://savelittlemichael.wordpress.com and our facebook is Save Little Michael (www.facebook.com/savelittlemichael). Thank you for your time, and please I beg you help us and help other children who will die because of this error with a medical food.