Other safety alerts
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European Union: Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera |
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The European Medicines Agency (EMA) has issued new advice for doctors and patients in order to minimise the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with the multiple sclerosis medicine Tecfidera (dimethyl fumarate).
Tecfidera is a medicine used to treat adults with multiple sclerosis, a disease in which inflammation destroys the protective sheath around the nerves. Tecfidera is used specifically in adults with relapsing-remitting multiple sclerosis, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
PML is a rare brain infection caused by John Cunningham (JC) virus. This virus is very common in the general population and is normally harmless. However, in persons whose immune system is compromised it can lead to PML, with symptoms that may be similar to those of a multiple sclerosis attack, and it may result in severe disability or death.
So far, 3 cases of PML have occurred in patients treated with Tecfidera who had not been treated before with other medicines known to be associated with a risk of PML. These cases occurred after long treatment in patients who had very low levels of lymphocytes, a type of white blood cell, over an extended period of time. Very low lymphocyte levels are known to develop in a small proportion of patients receiving Tecfidera. EMA started a review of this risk in November 2014, after the first case of PML was reported.
EMA has now recommended that a complete blood count should be performed before starting treatment with Tecfidera, and every 3 months during treatment. Additionally, a baseline MRI should be available (usually within 3 months) as a reference. If during treatment the levels of lymphocytes drop to very low levels for more than 6 months, the doctor should consider stopping Tecfidera. If treatment is continued, patients should be closely monitored.
EMA also reviewed cases of PML which occurred with two other fumarate-containing medicines, Fumaderm and Psorinovo, used to treat psoriasis. Related recommendations have been issued.
Detail information for patients and healthcare professionals can be found in the EMA's website.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002423.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there is no registered pharmaceutical product containing dimethyl fumarate. Related news has been issued by the US FDA, Health Canada and the MHRA, and was posted on the Drug Office website on 26 November 2014, 7 February 2015 and 31 March 2015 respectively.
Ends/ Saturday, October 24, 2015
Issued at HKT 12:00
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