FDA black box warning on atypical antipsychotics stating they may cause tardive dyskinesia

FDA black box warning on atypical antipsychotics stating they may cause tardive dyskinesia

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Kathleen Shea
Kathleen Shea signed this petition

Over 500,000 people in the U.S. have some form of tardive dyskinesia or other tardive syndromes (e.g., tardive dystonia) that cause involuntary movements of the face, limbs, torso and/or other body parts. This is a medication-induced disorder most commonly caused by dopamine receptor blocking agents (DRBAs), such as atypical antipsychotics. The literature cites that 20% of long-term users (more than a few months) may develop tardive dyskinesia from atypical antipsychotics. However, there have been cases of TD reported with only one dose of these drugs. These tardive syndromes are often permanent, disabling, and can be life-threatening.

The National Organization for Tardive Dyskinesia (NOTD) is petitioning that a black box warning be placed on all atypical antipsychotics by the Federal Drug Administration (FDA), stating that these drugs can cause tardive dyskinesia or other tardive syndromes which may be permanent and severely disabling, so that patients can make an informed decision with their practitioners. The following medications are included in this petition:

Abilify (aripiprazole)

Abilify Maintena (aripiprazole extended release injectable suspension)

Abilfy Mycite (aripiprazole tablets with sensor)

Clozaril (clozapine)

Fanapt (iloperidone)

Geodon (ziprasidone HCl)

Invega (paliperidone)

Invega Sustenna (paliperidone)

Invega Trinza (paliperidone palmitate)

Latuda (lurasidone HCl)

Rexulti (brexpiprazole)

Risperdal (risperidone)

Risperdal Consta (risperidone long-acting injectable suspension)

Saphris (asenapine sublingual tablets)

Seroquel (quetiapine fumarate)

Seroquel XR (quetiapine fumarate extended-release tablets)

Symbyax (olanzapine plus fluoxetine)

Vraylar (cariprazine)

Zyprexa Relprevv (olanzapine extended-release injectable suspension). The brand name atypical antipsychotic Zyprexa and Zyprexa Zydis are no longer being produced, but are still available as olanzapine and olanzapine orally disintegrating tablets.

The following generic atypical antipsychotic is available in the U.S. for research purposes only: amisulpride, which carries a risk of tardive dyskinesia. N-methyl amisulpride (LB-102) is in clinical trials in the U.S. and is expected to carry the same risk of tardive dyskinesia as amisulpride. Both of these should be included in the black box warning of tardive dyskinesia/tardive syndromes when FDA-approved.

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