The Food and Drug Administration has taken a decisive step towards expanding the scope of access to Kluzapin antipsychotic drugs, which is the only drug adopted for treatment -resistant schizophrenia, among the most devastating mental illnesses.
The agency announced on Monday that it was eliminating the condition of providing blood tests before filling their medical prescriptions.
Kluzapin, Which was approved In 1989, many doctors are the most effective treatment available for schizophrenia, and Research shows that the drug greatly reduces suicide behavior. Closabin is also associated with a rare side effect called neutrophils, a decrease in the census of white blood cells that can be life threatening in the most severe.
In 2015, Federal Organizers imposed a system known as risk evaluation strategies, or REMS, which require patients to undergo blood tests per week, every two weeks and monthly it had to be loaded on a database and verified by pharmacists.
Doctors have long complained about that, as a result, Kluzapin is not very exploited.
Dr. Friedrich C Nokifura, director of the schizophrenic clinic at Johns Hopkins College of Medicine, said he believed that about 30 percent of patients with schizophrenia will benefit from Clozapin – much more than 4 percent who are currently taking it.
He said: “I had many patients who were doing terribly, who struggled to work outside the hospital, and toured many medications.” “If they went on Kluzapin, they really tend to not enter the hospital again. I had people going to finish the college and work. It is very cool.”
The Food and Drug Administration (FDA) turned after years of pressure by pharmacists, doctors, and relatives of people with schizophrenia, who classified the cases of patients who deteriorated after the loss of Closapin.
“There were patients who ended up relapse in psychosis, the patients who ended up to the hospital, and the patients who became violent,” said Raymond C Loew, a honorary professor at the College of Pharmacy at the University of Maryland, who helped organize the effort.
He said that when a consulting committee reviewed the FDA at a November meeting, the agency had to expand the general list to accommodate the number of people who wanted to speak.
He said: “This was how screaming was.” “There were people crying.”
In a statement posted on its website on Monday, the FDA said it had decided that the test system “is no longer necessary to ensure the superiority of medicine” at the risk of severe Borbinia. Its spread is estimated at about 0.9 percent all over the world and decreases after the first six months of treatment.
But Dr. John M. Kane, a pioneer in schizophrenia, said he does not expect a major shift in his description as a result of change. Even without the test system, he said, many doctors hesitate to prescribe Clozapin because it requires close monitoring during the first months of treatment.
“One out of 8 patients in the United States who may benefit from Clozapin will occur,” said Dr. Kane, a professor of psychiatry at the Faculty of Medicine at the Zucker School at Hofstra/Northwel. He said that for a part of them, the drug “changes life.”
Mental disorders such as schizophrenia affect 1 percent to 3 percent of the adult population, but the disease is a burden of crushing on society. The disease usually appears in late adolescence and is characterized by psychotic symptoms, such as hallucinations or delusions, as well as through social withdrawal, cognitive weakness and a lack of motivation.
Studies indicate that the risk of suicide for people with schizophrenia is at least 10 times height As for the general population.
Although many people run their symptoms with the help of their families, others are studying through records, displacement and brief hospitalization. 2022 analysis of the economic burden associated with the disease published in the Journal of Clinical Psychiatry The annual cost was estimated At $ 343.2 billion, to a large extent of providing care, early death and unemployment.
The first antipsychotic drug, Chlorpromazine, became available 70 years ago, followed by two waves of new treatments designed to change dopamine paths in the brain. However, the pace of discovery slowed down, as large amounts of research funding were allocated to investigate the genetics of the disease. Last September, the Food and Drug Administration approved Cobenfy, R.The first anti -psychotic treatment novel In decades.
