Neutropenia Risk Prompts REMS for Antipsychotic Clozapine

clozapinelabelThe 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.

This article originally appeared on MPR.

The Pope’s Visits with President Obama Highlights the Pope’s Blessing of Ariana-Leilani

Pope Francis blesses Ariana-Leilani at the Vatican

Pope Francis blesses Ariana-Leilani at the Vatican

As a followup to Pope Francis’s blessing of Ariana-Leilani, in his meeting with Dr. Ariel Rosita King at the Vatican, urging Ariana-Leilani’s safe liberation from abuse, neglect and potentially fatal illness, the Pope has arrived in Washington DC to deliver his message to uplift those who are persecuted and the poor.

We hope that President Obama listens to his messages, and finally takes actions to protect Ariana-Leilani who lives several blocks from the White House in Washington, DC.

Please sign the petition to Save Ariana-Leilani and make Pope Francis’ blessings and wishes a reality.GoPetition

Girl With Rare Blood Disorder Works to Inspire Others

Kara Loader is just like any sixth grade girl. She’s been playing the violin for seven years, loves softball, and says she’s really good at school. She’s a huge Taylor Swift fan, and she has a lot of friends. But something sets Kara apart from her friends and classmates, though it’s nothing you’d be able to see on the outside.

11-year-old Kara has been battling severe congenital neutropenia since birth. Neutropenia is a rare blood disorder, meaning her body doesn’t make enough neutrophils in her white blood cells. So when Kara gets sick, or even gets a cut, her body may not fight off the infection as quickly. 

Kara has to be extra cautious and carry a medical kit with her at school, and when she gets really sick, Kara visits a hematology and oncology specialist at the Cleveland Clinic. She takes a shot of neupogen every day, which helps her build her neutrophils. However, she has to watch how much she takes, because the drug increases the risk of developing leukemia.

Kara has become a bit of a celebrity of her own in the neutropenia community. She said her video inspired a woman in her 30’s to talk about the disorder for the first time .”She always thought that it wasn’t okay, like, it wasn’t normal to tell people that you actually have it. And she said that my video actually gave her the courage to tell it to other people,” Kara said.

Kara said she has one message for anyone else battling neutropenia: “I would tell them everything’s going to be okay.” Kara and her family remain in contact with families they have encountered in the hospitals and at a yearly conference for neutropenia.

Ariana-Leilani also has suffered from neutropenia.   Sign her petition to assure she gets proper treatment and protection from abuse.

Read more: Kara Loader

 

Where does Hillary Clinton Stand on Children’s Rights in the USA?

Urge Secretary Clinton to Help Save Ariana-Leilani

How a leader handles a crisis reveals what they are made of and the quality of the people they choose to support them.   Do they respond with integrity?  Do they check the facts before they act?  Are they careful about who they get their information from?

Around the time the US press was preoccupied with the Bengazi scandal, the US Press overlooked another international scandal that was closer to home but just as concerning.

Due to concerns expressed by medical and humanitarian authorities, the UN Special Rapporteur on the sale of children, child prostitution and child pornography made an inquiry to Secretary Clinton’s US State Department questioning the US violations of the rights of dual citizen German-American Ariana-Leilani, who lives in Washington DC.

Rather than make an independent inquiry into those concerns, Secretary Clinton’s State Department blindly referred the matter to the District of Columbia Child and Family Services (DC CFS) — which has a well established record of incompetence that is so poor it is under a US Federal Court monitor.    Not surprisingly, the leaders of the DC CFSA at the time had known sex offenses (its Director having had sex with one of his young patients, and the other, its General Counsel, charged and placed on probation for indecent exposure in a public restroom).   Despite those sex offense records, both were allowed to run and operate the agency that was responsible for protecting DC’s children.   The then General Counsel of the DC CFSA, James Toscano Court Papers, personally interfered with Ariana-Leilani’s getting relief from abuse and neglect, including engaging in ex parte communications with a DC Superior Court judge and making false statements to that judge to help cover up the abuse and neglect that Ariana-Leilani was suffering.

As part of its coverup of the abuse and neglect of Ariana-Leilani, based on documents obtained from the Department of State, DC Child and Family Services Agency (DC Child Protection Services) had Mr. Toscano author the misleading and inaccurate response for the Department of State to the UN Special Rapporteur on the sale of children, child prostitution and child pornography.  Not surprisingly, his response was filled with misstatements of the facts, misleading the Secretary Clinton’s US Department of State, and in turn, the UN Special Rapporteur.

The real disappointment here is that Secretary Clinton’s Department of State blindly forwarded — under Secretary Clinton’s signature —  the Toscano-drafted response to the UN Special Rapporteur on the sale of children, child prostitution and child pornography.   We have to presume this was done by her without either checking the facts or checking the background of the author of the underlying letter.   As a result, the UN Special Rapporteur took no action and Ariana-Leilani continues to suffer.

In her run for the Presidential offices, Secretary Clinton should be as concerned about children’s rights and she is about women’s rights.   Unfortunately Secretary Clinton’s record has not demonstrated any concern for children’s rights — including failing to have the US ratify the UN Convention on the Rights of the Child.   Thus, help urge Secretary Clinton to protect children’s rights, to right this wrong, and to use her influence to help Save Ariana-Leilani…

GoPetition

TAKE TWO MINUTES ADD YOUR VOICE TO SHOW YOUR SUPPORT
TO SAVE ARIANA-LEILANI

DC Mayor Bowser

Child Abusers Among the Medical Community

In the US, doctors typically get automatic respect that most other members of society do not.   As a result, they often get a “free pass” for violating the law, particularly when it comes to sexual abuse of children.

However, a Cambodian court was not as impressed, and convicted a Syracuse ER Doctor of child sexual abuse.  He had traveled to Cambodia for charity.   That ER doctor spent 18 months in prison in Cambodia.   When the ER doctor came back to the US, the state ordered that he be classified as a sex offender based on his conviction overseas.  He fought that classification, but the Court of Appeals  in NY upheld the conviction.

Read more at:  NY court upholds Asian court’s child sex abuse conviction of former Syracuse ER doc

Ariana-Leilani and Other Children of Washington DC Need Protection

ariana-leilani

Ariana-Leilani

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.

Chicken That Can Kill

The Trouble with ChickenTo the average person, Salmonella may make the consumer sick, but to a persons with Neutropenia (low immunity) it can be fatal.   As explained in this Frontline expose, Salmonella is present in almost all chicken, and the types now being found in some chicken are resistant to many antibiotics.

Ariana-Leilani’s condition is a ticking time bomb…it is just a matter of time and the District of Columbia government refuses to take action to save her life.

Learn more: Chicken that Can Kill

Sepsis: The Uncontrollable Killer

sepsis

Just hours before he fell ill with sepsis and went to the hospital, and never went home.

Ariana-Leilani has been diagnosed with neutropenia — low immunity causing high risk of infection.   Although she can look perfectly normal, a few hours can mean the difference between life and death.   Neutropenic patients are particularly prone to sepsis, which is the most common killer of Americans.   It is an infection can suddenly turned into the life-threatening condition called septic shock.

Most vexing about sepsis is that doctors can only treat the symptoms. They don’t have an effective treatment for the underlying condition — antibiotics don’t work.

One thing that can help is prompt medical attention — especially when an infection is accompanied with some of the symptoms of sepsis, such as confusion, rapid heartbeat, shaking and skin rash.   In a neutropenic patient, like Ariana-Leilani, GCSF is one of the medicines that can boost the immune system.

Read more: Sepsis, A Wily Killer, Stymies Doctors’ Efforts To Tame It

Please sign Ariana-Leilani’s petition.

How to Play Through The Pain

Andrew Roberts is a Cape Henry sophomore who receives injections to treat cyclic neutropenia, a genetic disorder resulting from a lack of neutrophils, a type of white blood cell critical in fighting infection. According to the National Institutes of Health, cyclic neutropenia is estimated to affect one in one million people worldwide.

Roberts, though, has endured the daily, painful injections while playing No. 2 singles in his third varsity tennis season for the Dolphins.  Roberts’ lifelong condition recurs once per month and lasts for a week. Ulcers can develop in and around the mouth – so bad that Roberts sometimes is unable to speak or attend class.  Another debilitating symptom is exhaustion, something Roberts has overcome throughout his already-decorated high school and amateur careers. He must strive for about 12 hours of sleep per night, which proves difficult with an advanced-placement class schedule he hopes will eventually help him attend Princeton.

Read more: Andrew Roberts Plays Through the Pain