Red hand letter to the MS drug Tecfidera

Multiple sclerosis drug Tecfidera possible trigger of deadly side effects?

05/12/2014

In a recent red-hand letter, the manufacturer of the multiple sclerosis drug Tecfidera ® (dimethyl fumarate) has warned that patients with Tecfidera® who suffer from lymphopenia are careful and often show signs and symptoms of potentially fatal side effects Symptoms of neurological dysfunction should be monitored. In addition, regularly create a large blood picture.

„Tecfidera® is approved for the treatment of adult patients with relapsing-remitting multiple sclerosis“, can, however „cause lymphopenia, and in clinical studies the lymphocyte count decreased by approximately 30 percent during treatment“, reports the manufacturer Biogen Idec in the Rote-Hand-Brief. In a patient with severe and prolonged lymphopenia who has been treated with Tecfidera® for four and a half years, October 2014 is now a deadly one „progressive multifocal leukoencephalopathy (PML)“ occurred. This was the first case of PML linked to the drug and the current Red Hand Letter is intended to inform patients about the risk of this serious illness.

Brain infection as a result of lymphopenia?
Lymphopenia (lack of lymphocytes in the blood) is one of the long-standing side effects of the multiple sclerosis drug Tecfidera®. According to the manufacturer, the deceased patient also suffered from severe lymphopenia for about three and a half years. As a result of this lymphopenia, however, the risk of PML increases significantly. The PML is in turn „a rare and serious brain infection caused by the JC virus“, continues to explain the manufacturer Biogen Idec. Although this virus is widespread in the general population, it only leads to PML if the immune system has already been weakened. Like multiple sclerosis (MS), PML is a demyelinating disease that can be associated with severe neurological deficits.

First PML case related to the MS drug
If the symptoms indicate a PML or suspicion, treatment with Tecfidera ® should be stopped urgently according to the manufacturer. Here further investigations are necessary. Doctors are asked to inform their patients accordingly about the PML risk. While this is the first PML case associated with Tecfidera®, in the past, more PML cases have been reported in psoriasis patients with lymphopenia using fumaric acid esters, Biogen Idec reports. However, in the majority of cases, a causal relationship was not established. The pharmaceutical manufacturer is currently analyzing information available „Information and will work with the EMA to review any necessary changes in the Special and Use Information, including further recommendations for managing severe and prolonged lymphopenia and PML risk.“

Regular blood count checks required
To minimize the risk to health, Biogen Idec recommends careful monitoring of patients treated with Tecfidera® in the Rote-Hand-Brief. Here, a large blood count, including the lymphocyte count, should be established on a regular basis „and if clinically indicated, are determined at close intervals“, reports the manufacturer of the MS drug. In addition, attention must be paid to signs and symptoms of neurological dysfunction. Furthermore are „Healthcare professionals are encouraged to report any suspected adverse reactions associated with the use of Tecfidera ® in accordance with national requirements through the national spontaneous reporting system“, Biogen Idec says in the Rote-Hand-Brief. (Fp)