The death toll among people who have taken the schizophrenia drug Xeplion has climbed to 21, prompting the health ministry on Thursday to order the manufacturer to warn patients about its risks. The death toll was reportedly 17 on April 10.
Although a causal link between Xeplion and the deaths has not been established, the Health, Labor and Welfare Ministry ordered Janssen Pharmaceutical K.K., a unit of the U.S.-based Johnson & Johnson group, to revise its package insert, considering the unusually high number of deaths since the drug’s recent release.
An estimated 10,900 patients have been prescribed Xeplion since the drug was released last November, the ministry said.
Xeplion, which is injected, uses paliperidone palmitate to control symptoms of schizophrenia in adult patients. The chemical remains in the body for at least four months, it said.
To prevent further deaths, Janssen Pharmaceutical said it has instructed doctors to stay alert and refrain from prescribing the drug to patients whose treatment requires the use of more than one anti-psychotic medication.
While some of the 21 on Xeplion died from cardiac infarction or pneumonia, the cause of the other deaths hasn’t been determined. All died within three to 107 days of the first injection.
The reports also said some of the 21 patients were taking other anti-psychotic medications before trying Xeplion.
In Japan, the substance is injected every four weeks because it affects the body slowly over a few weeks.
Among its most frequently reported side effects are insomnia, headaches, respiratory tract infection, parkinsonism, increased weight, nausea, muscle and bone pain, tachycardia, tremors, abdominal pain, vomiting and diarrhea.
Schizophrenia is a chronic and severe mental illness that usually appears in late adolescence. Symptoms include disorganized thinking and speech, hallucinations, suspiciousness and delusions. In Japan, schizophrenia is the second-most prevalent mental disease after depression. About 800,000 people are undergoing treatment for the illness, the ministry said.