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The FDA Has Blood on Their Hands

Amarillo, Texas resident Kevin Keith Langemeier died on March 21, 2023, because the Clozapine REMS erroneously blocked his antipsychotic prescription for five days. The national story and his family's statement about clozapine restrictions can be found here.


“There is a tight timetable in which he can refill due to regulation surrounding the drug and the need for a blood draw. It's not something he can stockpile. His mother desperately tried to get his Clozapine restocked, but the Center in charge of his prescription had multiple delays for multiple reasons surrounding the government website supposedly being down, assigned staff being out, unanswered calls to them, mistakes made by other staff, and then regular closures on the weekend. She made multiple phone calls to the Center and also pleaded with multiple pharmacies to fill this prescription throughout the week before the incident. However, despite Kevin running out of Clozapine on Wednesday, it wasn't filled until Monday. This was the day before his death. By that point, his mental disorder had taken control and his mother didn't have resources to calm him down and stabilize him.”


- Statement from the Family of Kevin Keith Langemeier



A message to the Langemeier Family from The Angry Moms:


Our deepest condolences for your loss. We can see from his online presence that Kevin was a very dear man who courageously conquered his psychiatric challenges and became active with helping others through the National Alliance on Mental Illness (NAMI). Your son’s death was entirely preventable, and the FDA is directly responsible. Many agencies have been sounding the alarm about the deadly clozapine REMS program, including the American Psychiatric Association (APA), the Schizophrenia & Psychosis Action Alliance (S&PAA) and several others. The FDA has failed to take any meaningful action to reduce the well-known risks of interrupted clozapine treatment. The FDA has failed to address insurmountable barriers to this life-saving medication. The FDA’s regulatory policies represent complete detachment from the seriousness of psychiatric conditions and decades of systemic institutional discrimination. Mothers and caregivers fight weekly battles to ensure their loved ones have access to clozapine. We are forced to live in constant fear that this vital treatment could be interrupted with deadly consequences. The Angry Moms are fighting for change, and we are ready to fight for justice for Kevin Keith Langemeier.


- The Angry Moms


55 Comments


Guest
Oct 26

Condolences to the friends and family of Langemeier.


I think there should be a review of the process to make such requirements that can so easily effect the lives of the lives that depend on this medication. Does this help the community or hurt the community at scale? It's seems to be the later.


This on the double edged nature of making everything digital. When the system is down or has a issue there is no accountability or help after the fact. And unlike the cable going out this system being faulty can literally mean life or death, smh.


Either make REMS practical or completely remove it as a requirement for users of Clozapine. Remember the goal is to hel…

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Guest
Oct 26

My stepson is schizophrenic and faces constant risk of psychotic relapse due to the REMS. It's time to put an end to this dangerous system!

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Guest
Oct 24

My adult son is able to live a productive, safe, and happy life because of Clozaril.  But is always 48 hours away from losing it all. One bad blood work, one mistake in the lab, an uninformed pharmacist, a distracted doctor…and he will be gone again just like that. He spent years suffering with delusions, paranoia, fear, self-harm ideations, and aggressive behavior before we finally found a prescriber that was knowledgeable enough to prescribe it and encouraged us in maintaining the treatment despite the MANY UNNECESSARY hurdles the FDA has in place to receive it! End the REMS!! The research has been done and you all know better! Stop pretending there is anything to consider! My son was in more…

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cherryd2109
Oct 03

This needs to stop—help our loved ones

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Guest
Aug 31

If anyone from the FDA is reading this, please make the compassionate choice. As a schizophrenic man with an angry mother who has fought for me through hell, eventually finding clozapine to be a miracle drug to treat me, the elimination of obstacles to my medication would be life-changing. Without this drug, I am suicidal, violent, confused and tortured. With it, I am bursting with life and joy and living a successful life as a young man. Please make this medication accessible for those of us who experience the horrors of schizophrenia and psychosis.

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