The FDA extends access to clozapine, key treatment of schizophrenia

Food and Drug Administration has taken a key step towards increasing access to Klozapine antipsychotics, the only drug approved for treatment with resistant treatment, among the most destructive mental illness.

The agency announced on Monday that this eliminated the requirement that patients would submit blood tests before filling in the prescription.

Klozapina, which was approved in 1989, is considered by many doctors to be the most effective available schizophrenia treatment and Studies show that the drug significantly reduces suicidal behavior. Clezapine is also associated with a infrequent side effect called neutropenia, a decrease in white blood cells, which in the most severe form can endanger life.

In 2015, the Federal Regulatory Authorities imposed a diagram known as risk and limitation assessment strategies, or REMS, which required patients to undergo weekly, two -week and monthly blood tests, which had to be sent to the database and verified by pharmacists.

Doctors have long been complained of that as a result, Klozapine is grossly unused.

Dr. Frederick C. Nuciforny, director of the Schizophrenia Clinic for adults at Johns Hopkins School of Medicine, said that he thinks that about 30 percent of schizophrenia patients would benefit from the crosapine – much more than 4 percent who are currently taking it.

“I had many patients who did terribly, who fought for functioning outside the hospital and went through many drugs,” he said. “If they go to Klozapina, they are really not hospitalized again. I had people who graduate and work. It’s quite amazing. “

The change of FDA took place after years of lobbying by pharmacists, clinicists and relatives of people with schizophrenia, who cataloged the cases of patients who deteriorated after losing access to crosapine.

“There were patients who ended with psychosis, patients who finished hospitalized, patients who became violent,” said Raymond C. Love, a retired professor at the University of Maryland School of Pharmacy, who helped organize the effort.

When the FDA Advisory Committee reviewed this requirement at the meeting in November, the agency had to extend the public document to accommodate the number of people who wanted to speak.

“Such was outrage,” he said. “There were people in tears.”

In a statement published on its website on Monday, FDA stated that it determined that the test scheme “was no longer necessary to ensure that the benefits of the drug exceeded” the risk of severe neutropenia. Its dissemination is estimated at about 0.9 percent around the world and decreases after the first six months of treatment.

But Dr. John M. Kane, a leading schizophrenia researcher, said that he did not expect a significant change in rewriting as a result of change. He said that even without a test of testing, many doctors hesitates to prescribe clozapine, because this requires strict monitoring in the early months of treatment.

“Probably 1 out of 8 patients in the USA who could operate Clozapine,” said Dr. Kane, a professor of psychiatry at the Zucker School of Medicine in Hofstra/Northwell. He said that for them drugs “change life”.

Psychotic disorders such as schizophrenia affect 1 to 3 percent of the adult population, but the disease is a crushing burden on society. The disease usually occurs in the delayed puberty and characterizes butsychotic symptoms, such as hallucinations or illusions, as well as by social withdrawal, cognitive impairment and lack of motivation.

Research suggests that the risk of suicide of people with schizophrenia is at least 10 times more As for the general population.

Although many people deal with symptoms with the facilitate of their families, others go through imprisonment, homelessness and brief hospitalizations. Analysis of economic loads related to the disease published in the Journal of Clinical Psychiatry. estimated annual cost After $ 343.2 billion, mainly out of care, premature mortality and unemployment.

The first antipsychotic drugs, chlorpromazine, became available 70 years ago, and then two waves of modern treatment methods designed to change the trails of dopamine in the brain. But then the pace of discovery slowed down, because the huge sum of financing was devoted to the examination of the genetics of the disease. In September, the FDA approved Cobenfy, TFirst innovative antipsychotics In decades.