Schizophrenia drug withdrawn after fatal reports

Melleril, one of the oldest drugs prescribed for schizophrenia, has been voluntarily withdrawn following ongoing reports that it affected the heart’€™s rhythm with unconfirmed reports of deaths.

Dr Tobeka Boltina, medical advisor at Novartis, the manufacturers of Melleril, confirmed that Melleril was shown to have a strong effect on QT prolongation, a specific change in the ECG that shows the rhythm of the heart.

Scientific evidence on the connection between drug treatment and QT prolongation, cardiac arrhythmias and sudden death in patients with schizophrenia emerged in the 1990s. Schizophrenia is a severe mental disorder that disrupts a person’€™s ability to think, feel and relate to others and it affects about 24-million people worldwide.

Boltina failed to confirm whether Melleril, a drug used for the past 45 years, had been directly responsible for any deaths in people using the drug. She did, however indicate that as an additional precaution a statement was added to the product information leaflet in 2001, advising that a baseline ECG should be performed before initiating treatment with Melleril to exclude patients with relevant pre-existing cardiovascular disease.

Furthermore, Melleril’€™s indication was restricted to second-line treatment of schizophrenia in 2002. Boltina said that at the time Novartis recommended that physicians switch patients to alternative treatments.

She added that the availability of new antipsychotic treatments had changed the risk/benefit profile of older antipsychotics such as Melleril over time. Melleril’€™s risk/benefit profile no longer meets current clinical and regulatory expectations, prompting Novartis to withdraw it worldwide by June 30 this year.

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