ADR that result in revision of patient information
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| The United States: Clozapine: Drug Safety Communication - FDA modifies monitoring for neutropenia; approves new shared REMS Program |
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FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be life-threatening.
There are two parts to the changes in the requirements for treating patients with clozapine. First, FDA clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, FDA approved a new, shared risk evaluation and mitigation strategy (REMS) called the Clozapine REMS Program. The revised prescribing information and the Clozapine REMS Program will improve monitoring and management of patients with severe neutropenia. The shared REMS is also expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines. The requirements to monitor, prescribe, dispense, and receive all clozapine medicines are now incorporated into the Clozapine REMS Program.
Clozapine is an antipsychotic medicine used to treat schizophrenia in patients whose symptoms are not controlled with standard antipsychotic treatment. It is also used to treat recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.
Patients who are currently treated with clozapine will be automatically transferred to the Clozapine REMS Program. In order to prescribe and dispense clozapine, prescribers and pharmacies will be required to be certified in the Clozapine REMS Program according to a specific transition schedule starting October 12, 2015
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm462229.htm
In Hong Kong, there are 7 registered pharmaceutical products containing clozapine, and all of them are prescription-only medicines. In January and March 2012, the Department of Health (DH) issued letters to the registration certificate holders of the 7 products containing clozapine to remind them of the following registration requirements of their products:
1) the drug should only be supplied to psychiatrists with a prescribing guideline, a letter of undertaking to be signed by the psychiatrists declaring that he/she is familiar with the drug, including the restricted indications and risk of agranulocytosis;
2) patient blood monitoring programme to be implemented before, during, and after the discontinuation of the drug; and
3) patient information leaflet with warnings on the risks of the drug.
So far, DH has received two cases of adverse drug reaction after the use of clozapine, and one of them was related to agranulocytosis.
In view of the US FDA's announcement to enhance the prescribing information and risk management program for clozapine, DH will issue letters to inform local healthcare professionals about the warning, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, September 16, 2015
Issued at HKT 16:00
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