DOMPERIDONE: AN APPEAL FOR COMPASSION

On December 11, 2024, the FDA announced the cessation of the Expanded Access Program for Domperidone. In the wake of this decision, I would like to share a few comments from community members (who shall remain anonymous) about the impact of this decision on their health.

From my own experience, I can tell you that this medication was truly life-saving. I would not be here today without it. After diagnosis, I was so weak I could not lift my head off my pillow, could not manage even sips of liquid, and believed with all my heart I would die. All of that changed within days of starting Domperidone.

Make no mistake, there are no good alternatives for Gastroparesis patients who have likely already tried and been failed by other medications and treatments and who have relied on Domperidone to keep them alive and functioning. In many cases, Domperidone is a drug of last resort. This program is the difference between survival and starvation for many people in this community; needless suffering and deaths will result from this program's end.

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COMMUNITY REACTIONS, CONCERNS, AND EXPERIENCES

~ This was the only medication that worked to make my symptoms manageable. I am so upset! I'm only 23, was diagnosed at 21. Just feeling hopeless. I don't want to go back to the severe symptoms I had before having access to this medication.

~ I’ve been on it for 10 years, and without it, I can’t eat at all. It’s so scary, and we are helpless. Other countries make it, but it’s illegal for us to get it that way. I pray this changes

~ It was a game-changer for me. I’ve been on it for a few years, and I was in really bad shape before going on it. I am kind of freaking out.

~ Dreading the day. It helped me so much that I didn't need my feeding tube anymore.

~ They just don't care. The benefits of taking it far outweigh the cons. What about all of us who are living a better life with it? Don't we have a right to try?

~ Thanks to Domperidone, I am able to keep down small amounts of food and liquid. I implore you to seek legal avenues for patients like myself to continue accessing domperidone - whether through a new designated pharmacy, compounding pharmacies, or even ordering it from other countries.

~ I had the G-POEM in June, and they weaned me off Domperidone. That lasted a whole week before they put me back on it - worst week of my life! It was like I went back to square one, but worse! I cannot go without Domperidone or my life will change drastically! I won't have a life at all. Please, It's just awful without it!

~ This has been the only medication that has helped. I was told prior to starting it that if it failed, they would have to resort to surgical options. I truly hope this is figured out so those of us who have benefited don't have our treatments interrupted.

~ I cannot believe this! That’s like flat-out saying, “We, the FDA, do not care about Gastroparesis patients.”

~ Oh my God, I cannot go without Domperidone.

~ Omg, this is not good. It’s the only thing I can take that works.

~ Praying this doesn’t happen.

~ My 47-year-old disabled daughter, who has had very negative reactions to alternative medications, has taken Domperidone for 24 years. I just want her to live.

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POSSIBLE ALTERNATIVE TREATMENTS

Reglan/Gimoti is the only FDA-approved prokinetic for Gastroparesis. The following links provide additional information and perhaps a few treatments to be considered:

https://my.clevelandclinic.org/health/articles/prokinetic-agents

https://pmc.ncbi.nlm.nih.gov/articles/PMC8421525/

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We urge the FDA to find alternative sources, and short of that, we seek congressional intervention. The FDA and all of our policymakers must recognize the deeply negative impact the cessation of the Expanded Access Program for Domperidone will have on the gastroparesis community.

Crisis: Cessation of the FDA Expanded Access Program for Domperidone

On December 11, 2024, the FDA announced the following on its domperidone page: 

“Update: FDA was informed in late 2022 that the current supplier of domperidone was exiting the business due to transfer of ownership of the product to another company and, as such, will no longer supply domperidone tablets for treatment use under expanded access.  Efforts made in the interim to identify an alternative source have been unsuccessful. The current supply will be exhausted as early as the first or second quarter of 2025, at which time this program will no longer be able to supply domperidone for treatment use under your expanded access IND. FDA understands that this may pose challenges as you continue to care for your patient(s). We are making you aware of this development now so that you may begin to explore other treatment strategies.”

As a gastroparesis patient and advocate who has used and benefitted from the effects of domperidone for many years and has witnessed the advantages of this medication in the numerous online support groups I manage, this is alarming news.  I seek clarification and answers for my community.  

I initially contacted the FDA on December 13, 2024, to try to gain a better understanding of the situation and was denied additional information.  FDA staff, though congenial, would not specify whether the “supplier” in question was Dougherty’s Pharmacy (the only legal distributor of domperidone in the U.S. or Janssen, the manufacturer) and would not provide information as to the steps they had taken to “identify” an “alternative source.”  FDA staff indicated that the statement on the website would be the only information released to the public.  I expressed my deep concerns about the impact this would have on the gastroparesis community – as domperidone is a life-saving medication for some community members – and the narrow dissemination of the notice, as patients rarely, if ever, visit the FDA domperidone page. The FDA representative directed me to “spread the word” and consider contacting my congressional representatives (which I will gladly do). 

Upon the denial of additional details from the FDA, I contacted Dougherty’s Pharmacy directly and was informed by the pharmacy manager that they were unaware of the cessation of the FDA Expanded Access Program for domperidone.  The manager consulted the FDA website for confirmation while I was speaking with him and seemed stunned by the notice.  He instructed that he would speak with his contact at the FDA and call me back with any new information he was at liberty to share.  He contacted me the following day, after speaking with the FDA, and told me that the program seemed to be ending but he did not know the details.  He further stated that Dougherty’s was willing to continue to supply domperidone and would even compound the medication if permitted by the FDA because of domperidone’s life-saving importance to gastroparesis patients. 

After speaking with the pharmacy manager the second time, I contacted the medical science department at Janssen and spoke with a representative who, though not familiar with Motilium/domperidone, researched the product status in the system and noted that the current status of domperidone had not changed; the system indicated that Janssen was still manufacturing and providing domperidone to the FDA Expanded Access Program and there was no indication in the system that this would cease. 

Since the answers I received from Dougherty’s and Janssen did not make sense in the light of the FDA notice, I contacted the FDA again on January 7, 2025.  Again, I was denied details and was told that the program would end.  The Patient Affairs representative I spoke with wished to be helpful but did not have adequate information to supply.  She offered to research the issue and contact me once she had done so.  She contacted me the following day but could tell me no more than the update on the FDA site was the correct and only information that the public would currently be supplied.  She further encouraged me to detail the issues in a follow-up message to the FDA. 

I seek answers to the following questions:

 · Who is the “supplier” mentioned in the FDA update?  Is this Dougherty’s, Janssen, or a third party of which I am unaware?

· If Dougherty’s or Janssen is the “supplier” mentioned, why was neither party aware of the cessation of the program?

· Since the FDA has known about the supply issues since 2022, why is the gastroparesis community only now, more than 2 years later, being informed of the crisis?  Does the FDA consider this adequate notice for doctors and patients who will struggle to identify new treatment strategies?  What additional steps have been/will be taken to inform doctors and patients of the program cessation?

· What steps have been taken since 2022 to identify an alternate supplier?  Who has already been contacted and who is on the list of future contacts?  Why are there no other alternatives for obtaining domperidone if another supplier cannot be identified?

· What “other treatment strategies” does the FDA deem available to the gastroparesis community since only one medication (Reglan/Gimoti) has been approved by the FDA for use in gastroparesis patients (and that medication comes with a black box warning)?  (It should be noted as well that most patients prescribed domperidone have already tried and been failed by Metoclopramide.) 

The FDA must recognize the deeply negative impact the cessation of the Expanded Access Program for domperidone will have on the gastroparesis community.  Make no mistake, this program is the difference between survival and starvation for many people in this community; needless suffering and deaths will result.  I seek information and solutions on behalf of my community members and will not rest until I have them.