Require Black Box Warnings to Explicitly Name and Describe Akathisia

Recent signers:
Katharine Keenan and 19 others have signed recently.

The Issue

 

 

 

Akathisia is a neuropsychiatric movement disorder often caused by medications which causes such symptoms as:

 

Profound restlessness/irritability

Rage

Insomnia

Pacing/fidgeting

An inability to sit or lie down

Racing thoughts

Feelings of intense doom

Adrenaline surges

Nervous system instability

Cognitive defects, and worse of all

Suicidality/Homicidality


In one Facebook support group alone, Living With Akathisia, 100+ members have taken their own lives since it’s creation in 2014. The group at its current time consists of 3.6K members. That is how life threatening this disorder is. 

 

The disorder is often either not well known about in the medical community or masked and frequently labeled as psychiatric issues, regardless of the disorder being listed under medication side effects in both the DSM and ICD and being medically known as a movement disorder. 

 

These are four studies published by The National Institute Of Health that help to show the wide prevalence of Akathisia:


With antipsychotics:

“a prevalence of 21% in those on first-generation antipsychotic monotherapy. For those receiving second-generation antipsychotic monotherapy, the prevalence was 11%, whereas polypharmacy with 2 second-generation antipsychotics was associated with a prevalence of 34%.”

https://pmc.ncbi.nlm.nih.gov/articles/PMC6299189/

 

With antidepressants:

“Akathisia was observed in 25% (50/198) of patients.”

https://pubmed.ncbi.nlm.nih.gov/39374042/

With Reglan, an antiemetic highly used for chemo patients and for migraine patients in an ER setting:

“Metoclopramide has been linked to akathisia in many reports and the incidence of restlessness reported after IV administration of drug is 20–25%.”

https://pmc.ncbi.nlm.nih.gov/articles/PMC3511976/


Among cancer patients given Prochlorperazine:

“A psychiatric diagnosis was made in 420 (87.0%) of the 483 cancer patients examined, and akathisia, a drug-induced movement disorder, was unexpectedly prevalent among the patients; 20 of 420 (4.8%) patients had developed akathisia from an antiemetic drug, prochlorperazine.”

https://pubmed.ncbi.nlm.nih.gov/18044412/


Black box warnings for medications that can cause suicidality/homicidal thoughts and actions exist, yet the word “akathisia” itself is not used in the warning. 


We, the signers, call for black box labels to include the following wording among drugs known to increase risks for suicidal and homicidal thoughts and actions:

“Akathisia, a neuropsychiatric movement disorder tied to suicidality/homicidality”

 


We ask that the decision makers strive towards adding this statement to medications with well-established risks for akathisia, severe restlessness, and suicidality/homicidality, including but not limited to:

Antidepressants

Antipsychotics (including those currently in use as antiemetics) 

All Dopamine D2 Blockers/Dopamine Agonists

Fluoroquinolones

Benzodiazepines 

All other drugs known for increased suicidality/homicidality

 

Our reasoning as for the urgency of such a statement include: 

  1. One should be informed of the risks of developing this condition. In the absence of a clear warning, patients and caregivers may be unable to recognize early signs of akathisia—such as pacing, severe inner restlessness, and an inability to remain still—delaying identification and appropriate intervention. 
  2. Not listing the disorder itself is misleading as it gives the illusion that the side effects can be reversed simply by no longer taking the med. This is not always true as the disorder  and the thoughts can remain upon cessation of the med as the disorder can still remain.
  3. Not listing the disorder also creates the belief that these thoughts are purely psychological in nature and may be a result of the condition that the meds are being taken for. It is in fact a new condition of the akathisia caused by the medication. 
  4. Not being opaque as to what could be causing this suicidality/homicidality may prevent timely recognition and appropriate care. 

     

    We call on the following global health leaders and regulatory authorities to take immediate action to protect patients from the devastating and often unrecognized effects of akathisia:


    Dr. Martin A. Makary, Commissioner of the U.S. Food and Drug Administration


    Emer Cooke, Executive Director of the European Medicines Agency


    Lawrence Tallon, Chief Executive of the Medicines and Healthcare products Regulatory Agency


    Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization

     

    These individuals and organizations hold the authority and responsibility to ensure that medication risks are communicated clearly, accurately, and transparently. We urge them to mandate stronger warnings to reflect the seriousness and potential permanence of akathisia  


Greater awareness and transparency can save lives.

119

Recent signers:
Katharine Keenan and 19 others have signed recently.

The Issue

 

 

 

Akathisia is a neuropsychiatric movement disorder often caused by medications which causes such symptoms as:

 

Profound restlessness/irritability

Rage

Insomnia

Pacing/fidgeting

An inability to sit or lie down

Racing thoughts

Feelings of intense doom

Adrenaline surges

Nervous system instability

Cognitive defects, and worse of all

Suicidality/Homicidality


In one Facebook support group alone, Living With Akathisia, 100+ members have taken their own lives since it’s creation in 2014. The group at its current time consists of 3.6K members. That is how life threatening this disorder is. 

 

The disorder is often either not well known about in the medical community or masked and frequently labeled as psychiatric issues, regardless of the disorder being listed under medication side effects in both the DSM and ICD and being medically known as a movement disorder. 

 

These are four studies published by The National Institute Of Health that help to show the wide prevalence of Akathisia:


With antipsychotics:

“a prevalence of 21% in those on first-generation antipsychotic monotherapy. For those receiving second-generation antipsychotic monotherapy, the prevalence was 11%, whereas polypharmacy with 2 second-generation antipsychotics was associated with a prevalence of 34%.”

https://pmc.ncbi.nlm.nih.gov/articles/PMC6299189/

 

With antidepressants:

“Akathisia was observed in 25% (50/198) of patients.”

https://pubmed.ncbi.nlm.nih.gov/39374042/

With Reglan, an antiemetic highly used for chemo patients and for migraine patients in an ER setting:

“Metoclopramide has been linked to akathisia in many reports and the incidence of restlessness reported after IV administration of drug is 20–25%.”

https://pmc.ncbi.nlm.nih.gov/articles/PMC3511976/


Among cancer patients given Prochlorperazine:

“A psychiatric diagnosis was made in 420 (87.0%) of the 483 cancer patients examined, and akathisia, a drug-induced movement disorder, was unexpectedly prevalent among the patients; 20 of 420 (4.8%) patients had developed akathisia from an antiemetic drug, prochlorperazine.”

https://pubmed.ncbi.nlm.nih.gov/18044412/


Black box warnings for medications that can cause suicidality/homicidal thoughts and actions exist, yet the word “akathisia” itself is not used in the warning. 


We, the signers, call for black box labels to include the following wording among drugs known to increase risks for suicidal and homicidal thoughts and actions:

“Akathisia, a neuropsychiatric movement disorder tied to suicidality/homicidality”

 


We ask that the decision makers strive towards adding this statement to medications with well-established risks for akathisia, severe restlessness, and suicidality/homicidality, including but not limited to:

Antidepressants

Antipsychotics (including those currently in use as antiemetics) 

All Dopamine D2 Blockers/Dopamine Agonists

Fluoroquinolones

Benzodiazepines 

All other drugs known for increased suicidality/homicidality

 

Our reasoning as for the urgency of such a statement include: 

  1. One should be informed of the risks of developing this condition. In the absence of a clear warning, patients and caregivers may be unable to recognize early signs of akathisia—such as pacing, severe inner restlessness, and an inability to remain still—delaying identification and appropriate intervention. 
  2. Not listing the disorder itself is misleading as it gives the illusion that the side effects can be reversed simply by no longer taking the med. This is not always true as the disorder  and the thoughts can remain upon cessation of the med as the disorder can still remain.
  3. Not listing the disorder also creates the belief that these thoughts are purely psychological in nature and may be a result of the condition that the meds are being taken for. It is in fact a new condition of the akathisia caused by the medication. 
  4. Not being opaque as to what could be causing this suicidality/homicidality may prevent timely recognition and appropriate care. 

     

    We call on the following global health leaders and regulatory authorities to take immediate action to protect patients from the devastating and often unrecognized effects of akathisia:


    Dr. Martin A. Makary, Commissioner of the U.S. Food and Drug Administration


    Emer Cooke, Executive Director of the European Medicines Agency


    Lawrence Tallon, Chief Executive of the Medicines and Healthcare products Regulatory Agency


    Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization

     

    These individuals and organizations hold the authority and responsibility to ensure that medication risks are communicated clearly, accurately, and transparently. We urge them to mandate stronger warnings to reflect the seriousness and potential permanence of akathisia  


Greater awareness and transparency can save lives.

The Decision Makers

Lawrence Tallon
Lawrence Tallon
Chief Executive of the Medicines and Healthcare products Regulatory Agency
Emer Cooke
Emer Cooke
Executive Director of the European Medicines Agency

Supporter Voices

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