Remove Citric Acid Monohydrate from Humira in the United States

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My seven year old daughter was diagnosed with severe Crohn's disease at the age of four. After becoming steroid dependent and failing Apriso, she began intravenous Remicade. Eventually we had to add in Methotrexate as well and drastically changed her diet to follow the Specific Carbohydrate Diet. My child failed Remicade and Methotrexate even at higher than the double dose every four weeks and has been flaring since June 18, 2017. She did not form antibodies, she simply lost response.

My child has endured several hospitalizations, complications, and has been in medical distress several times. She has previously lost the ability to walk, talk, eat, and drink. She has been on feeding tubes, PICC lines, has had several colonoscopies and endoscopies, and has spent holidays in a hospital bed. She has run a fever of 106, dropped weight rapidly due to her 20 plus excruciating bowel movements daily, developed re-feed syndrome, and is presently on her tenth week of exclusive enteral nutrition (forgoing all food and replacing it instead with dietary formula) to try to induce remission. My daughter is still not in remission.

The recommendation of the medical teams we have in two states is that she begins Humira. Humira is used to treat several autoimmune illnesses and is frequently used in pediatric patients. Our children endure immense pain and suffering at the hands of their chronic and incurable illnesses and depend heavily on medication to reach remission. We pray Humira is what works for my daughter. However, I am unclear as to why AbbVie, the company that manufactures Humira, is still using citric acid monohydrate in their formula. Removal of this ingredient has already taken place in the UK and a "pain free" version has been on the market for some time now. Upon further research it appears the FDA has approved the removal of this ingredient from the US Humira formulation. I urge AbbVie to work with the FDA to remove the ingredient and provide US residents with the same options that are available to our fellow IBD patients across the pond. 

My little girl starts Humira in two weeks and the thought of causing her any additional distress by administering a medication whose burning sensation has been likened to ten wasp stings at once by several Humira users is upsetting to me. I will do whatever is necessary to advocate and care for my child but I will not stand silently and idly by when there is a better option waiting to be manufactured. 

Please join me in petitioning AbbVie and the FDA to begin manufacturing the citric acid monohydrate free version in the United States. I believe if they hear from patients and caregivers, they may see the human face of the thousands of children they could further help by significantly reducing their pain while dosing. I urge AbbVie to update patients on timelines and to provide us with hope for a change.



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