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FDA ... Clozapine ... Changes being made


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http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm463614.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Just got this in an email today.  Thought I'd share it, in case it might help someone.

On September 15, 2015, FDA announced it is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia.

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You left out the part that says anything

The Clozapine REMS Program replaces the six existing clozapine registries maintained by individual clozapine manufacturers and requires prescribers, pharmacies, and patients to enroll in a single centralized program. Patients currently treated with clozapine will be automatically transferred to the shared REMS. Prescribers and pharmacies will be required to be certified in the shared REMS according to a specific transition schedule starting October 12, 2015.

Monitoring recommendations for neutropenia caused by clozapine have changed. Neutropenia will be monitored by the absolute neutrophil count (ANC) only, rather than in conjunction with the white blood cell count. Moreover patients will be able to continue clozapine with a lower ANC, allowing continued treatment for more patients. Additionally, patients with benign ethnic neutropenia who were previously ineligible will now be able to receive clozapine. This facilitates prescribers’ ability to make individualized treatment decisions if determined that the risk of psychiatric illness is greater than the risk of recurrent severe neutropenia, especially in those whom clozapine may be the antipsychotic of last resort.

 

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Right, I did leave it out.  I figured if someone was interested enough in it they'd click on the link in OP ... all it says is how things are changing with clozapine ... the monitoring protocol will change.  Some people will now be eligible for it.  It might, or might not, help someone.  Thought I'd post it just in case.  You never know, it might make a difference for someone out there.

patients with benign ethnic neutropenia who were previously ineligible will now be able to receive clozapine.

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Thanks for posting this.  I hope my pharmacist knows about this and I won't have any hiccups with my prescription.  They seem to screw things up about 3 out of every 4 times, so I'm afraid of this change.

Last week was the second time in my 2 years of taking Clozapine that I have had a low ANC and have had to recheck a week later.  This time it seemed like she wasn't going to give me my prescription because she was worried that I wouldn't recheck the next week, but I told her that it happened once before and I followed their instructions.

Fortunately both times my labs were back in range the next week.  I really worry what they will do if it's not.  I guess I don't want to know, so I don't bring it up.

Do you think I should be proactive and notify them about this change?

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Do you think I should be proactive and notify them about this change?

I think proactive is a great idea, and to notify both pharmacist and pdoc about the changes.   ... so if there is any question you can back your self up saying that changes were made, and tell them about it if they don't already know about it.

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