The Food and Drug Administration (FDA) has announced changes to prescribing information for the atypical antipsychotic clozapine and a new shared risk evaluation and mitigation strategy (REMS) due to continuing safety concerns and current knowledge regarding the risk of severe neutropenia. Clozapine is indicated for the treatment of resistant schizophrenia and to reduce the risk of recurrent suicidal behavior in schizophrenia and schizoaffective disorders.
The requirements to monitor, prescribe, dispense, and receive clozapine are now incorporated into the new shared Clozapine REMS Program, which replaces the six individual clozapine registries. The REMS program includes all clozapine medicines in order to provide a centralized point of access for prescribers and pharmacists in managing the risk of neutropenia. Starting October 12, 2015, clozapine will be available only through the Clozapine REMS Program.
Important changes to the neutropenia monitoring recommendations and treatment algorithm for clozapine include:
- Absolute neutrophil count (ANC) is the only test result accepted in the Clozapine REMS Program to monitor for neutropenia.
- If the patient is an outpatient, the ANC must be reported to the Clozapine REMS Program before clozapine is dispensed.
- If the patient is an inpatient, the ANC must be reported within 7 days of the most recent blood sample.
- Patients with benign ethnic neutropenia (BEN) can now be treated with clozapine.
In a recent letter to the Editor of the Washington Post, a Marie Cohen, a social worker, writes about the failures of DC’s Child and Family Services (CFSA) and missing child Relisha Rudd’s, who before she went missing, had been subjected to sexual abuse right under the nose of the Washington DC CFSA (its child protection agency):
Relisha’s family was known to the CFSA. The family had been the subject of several reports. There were numerous indications that the family was in trouble. Relisha’s brothers had frequent behavior problems at school, often a sign of trouble at home. School staff reported numerous warning signs, such as Relisha missing more than 30 days of school, Relisha often arriving for class dirty and Relisha and one of her brothers left waiting at school at the end of the day.
If the CFSA had an open case on the family, a social worker was expected to visit the family at least twice a month. It would have been a social worker’s job to make sure Relisha was okay.
The CFSA has been touting its success in taking fewer children into foster care. The acting director reported proudly this year that 62 percent of the children it serves are at home. That is good news indeed, as long as the children who are with their families are receiving the monitoring and services they need to be safe. Relisha certainly was not.
Like Relisha, 12 year old Ariana-Leilani continues to suffer, but despite clear evidence of abuse and neglect, CFSA refuses to even maintain an open case on her.
Along with almost 5000 signers of Ariana-Leilani’s Petition, the DC Council and Mayor Bower should take the social workers’ letter seriously, and not only look more closely at Relisha Rudd’s case, but also direct CFSA to maintain an open case for 12 year old Ariana-Leilani.
See full text of Marie Cohen’s letter: Protecting the Next Relisha (Washington Post)
Read More for background: Relisha.
Ariana-Leilani quietly suffers in Washington DC, living in a small one bedroom apartment in walking distance to downtown Georgetown. Washington DC is about to elect a new mayor in November 2014. The candidates are Muriel Bowser, David Catania, and Carol Schwartz.
Regardless of which of them wins, it is going to be up to that winner to protect Ariana-Leilani. So, whichever candidate you support, support Ariana-Leilani.
Gathering parents and children, like Ariana-Leilani, from all across North America, to meet and hear from each other and leading Neutropenia experts, the National Neutropenia Network held another successful conference July 11-13, 2014. Among the distinguished presenters were Dr. Dale (University of Washington), Dr. Laurence Boxer (C.S. Mott Children’s Hospital), Dr. Peter Newberger (UMass), Dr. Mary Ann Bonilla (St. Joseph’s Regional Medical Center). To learn more go to http://www.neutropenianet.org/conference
Congratulations to Ariana-Leilani from her mother Dr. Ariel King. Although Ariana-Leilani has made it this far, she still needs your help in urging that she get the free medicine and an second medical opinion she needs to finally rid herself of her Severe Chronic Neutropenia.
Sign her petition today:http://www.ariana-leilani.com
Ryder Arnold is fifteen months old, and like Ariana-Leilani, has the rare blood disorder Neutropenia, which compromises the immune system. Although Neutropenia is a non-cancerous disease, many treatments are the same as cancer patients constantly monitoring the ANC (a count that reveals the immune system’s strength), bone marrow biopsies, and takes Neupogen injections each day to help boost the immune system.
At this point, Ryder’s prognosis, like Ariana-Leilani’s, is unclear.
Friends of Arnold’s have organized a benefit for Ryder. They have named it “Rock out for Ryder.” Some of the proceeds will be donated to the Ella Jewell Foundation, which is a Neutropenia research foundation named after a little girl who died of Neutropenia. Rock Out for Ryder will take place on Friday, May 16, at the Music Union Hall (116 N. Green Street). Three rock bands will perform: The War I Survived, Mudoon’s Clever Girls, and Canzo. The show begins at 7 p.m., admission is $5 and the event is BYOB. All ages are welcome.
Ariana-Leilani is being denied the Neupogen that is helping to keep Ryder alive. Please consider signing her petition to get proper treatment:
TAKE TWO MINUTES ADD YOUR VOICE TO SHOW YOUR SUPPORT
TO SAVE HER