Changes Announced for Monitoring Clozapine to Improve Delivery of Treatment, Increase Access

What makes clozapine a unique and effective antipsychotic? As I detailed in my recent Advocate piece, Clozapine is the only FDA-approved medicine for treatment resistant schizophrenia. It’s been found to be effective in treatment resistant schizophrenia and in reducing the risk of suicide in people who have schizoaffective disorder or schizophrenia. I feel it is underutilized, and have seen many good outcomes on this medication. The one caveat of this medication is that it requires vigilance to monitoring of medical side effects.

A recent announcement by the FDA stated that beginning October 15 it will change the approach to monitoring clozapine. There are two key areas that are being changed, which both strike me as substantial improvements. The changes address a rare but serious side effect of clozapine, which is the reduction of a specific type of white cells called neutrophils. For those taking clozapine, having their blood drawn on a structured schedule monitors their neutrophil counts (the schedule is not changing as a result of these changes). Greatly reduced neutrophil counts can lead to risk of infection or death, which is why monitoring for this risk is incredibly important. This is especially true during the first six months of treatment when the risk is greatest.

Here are the announced changes to monitoring clozapine:

1. There will only be one centralized clozapine registry, called the Risk Evaluation and Mitigation Strategies (REMS). REMS will keep track of a person’s neutrophil counts to be sure no one who has too low of a count gets the medicine. Currently there are six different registries, and this can cause delays as well as increasing the chance for error. This change to one registry will streamline the monitoring component of clozapine. If you have any questions, ask your local pharmacy or staffer who runs your clozapine clinic.

2. Clinically, the new changes will allow for more physician and patient discretion in some situations that involve a low neutrophil count.  Some individuals have low counts even before they start the treatment, which has shown to be more common in some ethnic groups. This is called Benign Ethic Neutropenia or BEN. The FDA is allowing these individuals to review the risks and benefits of taking the medicine with their doctor. In short, it allows for more clinical flexibility and shared decision making than the more absolute structure of the older system. Questions? Ask your prescribing doctor.