Latest news with #Clozapine
The Guardian
22-05-2025
- Health
- The Guardian
Bondi Junction inquest told most people with treatment-resistant schizophrenia relapse without medication
About 90% of people who have treatment-resistant schizophrenia and discontinue their antipsychotic medication relapse after two years, a coronial inquest has heard amid a probe into the mental health and care of Joel Cauchi. The inquest, scheduled for five weeks, is examining the fatal stabbing of six people by Cauchi at Westfield Bondi Junction in April 2024. Cauchi, then 40, killed Ashlee Good, 38, Jade Young, 47, Yixuan Cheng, 27, Pikria Darchia, 55, Dawn Singleton, 25, and Faraz Tahir, 30, and injured 10 others at the shopping centre on 13 April last year before he was shot and killed by police officer Amy Scott. At the time, Cauchi was not medicated for his schizophrenia, the coroners court has heard. He had been weaned off medication by a psychiatrist and was meant to be monitored, but wasn't. On Thursday, the inquest heard from a panel of psychiatrists who provided expert opinions on the care and treatment of Cauchi. The court heard that Clozapine – which can have severe side effects – was generally considered a life-long medication for people with treatment-resistant schizophrenia due to a high relapse rate of 77% after one year and 90% after two years for those who stopped taking it. Psychiatrist Prof Olav Nielssen told the court that homicide of strangers by people with schizophrenia was rare, with one occurring in New South Wales about every two years. He said a 'feature of that small group' was having gone off medication and homelessness. Cauchi was unmedicated and homeless at the time of the Bondi Junction stabbings. Prof Merete Nordentoft, a psychiatrist in Denmark, told the Sydney court: 'Most people with schizophrenia will never commit an act of serious violence, but a disproportionate number of homicides are committed by people with psychotic illness.' Those who do harm others, Nordentoft said, usually had delusions including thinking they were 'being followed and somebody is trying to harm you, and therefore you need to protect yourself'. Sign up to Morning Mail Our Australian morning briefing breaks down the key stories of the day, telling you what's happening and why it matters after newsletter promotion She said in Copenhagen there were clinics that supported patients who wanted to come off anti-psychotic medication. The patients had weekly monitoring for 18 months. But, the psychiatrist told the court, most people found they couldn't completely end their medication. 'The patients actually get a higher level of acceptance that this treatment is needed,' she said, noting the process had a silver lining.
The Advertiser
15-05-2025
- Health
- The Advertiser
'Red flag': warning sign when killer wanted gun licence
The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications in a bid to get a gun licence years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636 The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications in a bid to get a gun licence years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636 The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications in a bid to get a gun licence years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636 The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications in a bid to get a gun licence years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636
The Advertiser
15-05-2025
- Health
- The Advertiser
'Red flag': warning sign when Bondi killer wanted a gun
The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications to get a gun years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636 The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications to get a gun years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636 The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications to get a gun years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636 The man responsible for the Bondi Junction stabbing attack gave false information about his antipsychotic medications to get a gun years earlier. Joel Cauchi, 40, killed six people and injured 10 others at Sydney's Bondi Junction Westfield in April 2024 before being shot dead by police. In January 2021, he approached a Brisbane psychiatrist seeking medical clearance to get a licence so he could shoot pistols under supervision at a local gun range. The doctor testified at an inquest on Thursday. Cauchi told him he had been on the antipsychotic Clozapine for only two years before coming off it 18 months earlier. However, reports obtained by the doctor from Cauchi's former private psychiatric clinic in Toowoomba revealed he had been on the medication for 16 or 17 years since being diagnosed with schizophrenia as a teen. The psychiatrist, who cannot be legally identified, admitted under questioning by counsel assisting Emma Sullivan that this was a "red flag". He acknowledged he should not have supplied Cauchi with a medical report. This document deemed him to be a "fit and proper person" to hold a gun licence and was sent to Queensland Police. Police granted Cauchi a certificate of eligibility but he never applied for a gun licence. The psychiatrist said if he had known of prior concerns raised by Cauchi's mother about declines in his mental health, he would have reached out to her to learn more. These potential signs of relapse included a large number of notes being left around the house - some referring to satanic control - excessive obsessive-compulsive disorder, an obsession with pornography, irritability and a strange gait. Records supplied by the Toowoomba psychiatric clinic did not contain this information, despite his mother contacting them repeatedly after his antipsychotic medication was ceased in mid-2019. The Brisbane doctor said he had provided the medical report to police after finding Cauchi a "very low risk to himself and others". The document should have noted he had only seen Cauchi once and was not his regular psychiatrist, he told the court. "In hindsight, I would have done things a lot differently," he said by videolink. A lack of available detail about Cauchi's history was also a theme when his former general practitioner Richard Grundy gave evidence. He testified he was not told of any concerns when Cauchi relocated from Toowoomba to Brisbane in early 2020. Dr Grundy said he would have attempted a follow-up if he had been told about the concerns raised by Cauchi's mother. "I didn't have any information - all those things that were discussed for some reason or another never came to me," Dr Grundy told the court by videolink from London. On discharging Cauchi from her clinic in March 2020, his private psychiatrist sent a letter to Dr Grundy. "Please recall Joel to discuss his options and referral to an alternative psychiatrist if required," she wrote. In earlier evidence given to the coroner, she insisted she had a lengthy phone conversation with Dr Grundy after sending this letter. "I can take Joel back, I am the family GP, I know him very well and I will recall (him)," the GP told her, according to her evidence. But on Thursday, he denied that this conversation took place. By mid-2019, Cauchi was completely off the antipsychotics and he became detached from the mental health system early the following year after moving to Brisbane. The inquest continues on Monday. Lifeline 13 11 14 beyondblue 1300 22 4636
New York Times
26-02-2025
- Health
- New York Times
F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia
The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses. The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled. Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that the drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening. In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists. Physicians have long complained that, as a result, clozapine is grossly underutilized. Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it. 'I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,' he said. 'If they go on clozapine, they really tend to not be hospitalized again. I've had people go on to finish college and work. It's quite remarkable.' The F.D.A.'s shift came after years of lobbying by pharmacists, clinicians and relatives of people with schizophrenia, who cataloged the cases of patients who deteriorated after losing access to clozapine. 'There were patients who ended up relapsing into psychosis, patients who ended up hospitalized, patients who became violent,' said Raymond C. Love, a professor emeritus at the University of Maryland School of Pharmacy, who helped organize the effort. When an advisory committee to the F.D.A. reviewed the requirement at a meeting in November, he said, the agency had to expand the public docket to accommodate the number of people who wanted to speak. 'That was how much the outcry was,' he said. 'There were people in tears.' In a statement published on its website on Monday, the F.D.A. said it had determined that the testing regimen was 'no longer necessary to ensure that the benefits of the medicine outweigh' the risk of severe neutropenia. Its prevalence is estimated at around 0.9 percent worldwide and decreases after the first six months of treatment. But Dr. John M. Kane, a leading schizophrenia researcher, said he did not expect a substantial shift in prescribing as a result of the change. Even without the testing regimen, he said, many physicians are hesitant to prescribe clozapine because it requires close monitoring during the early months of treatment. 'Probably 1 in 8 patients in the U.S. who might benefit from clozapine are getting it,' said Dr. Kane, a professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell. For a portion of them, he said, the medication is 'life-changing.' Psychotic disorders like schizophrenia affect 1 percent to 3 percent of the adult population, but the disease is a crushing burden to society. The illness typically emerges in late adolescence and is characterized bypsychotic symptoms, like hallucinations or delusions, as well as by social withdrawal, cognitive impairment and a lack of motivation. Studies suggest that the risk of suicide for people with schizophrenia is at least 10 times as high as that for the general population. Though many people manage their symptoms with the help of their families, others cycle through incarcerations, homelessness and brief hospitalizations. A 2022 analysis of the economic burden associated with the disease published in The Journal of Clinical Psychiatry estimated the yearly cost at $343.2 billion, largely from caregiving, premature mortality and unemployment. The first antipsychotic medication, chlorpromazine, became available 70 years ago, and was followed by two waves of new treatments designed to alter dopamine pathways in the brain. But the pace of discovery slowed after that, as vast sums of research funding were devoted to investigating the genetics of the disease. Last September, the F.D.A. approved Cobenfy, the first novel antipsychotic treatment in decades.
