Drug Safety Developments

Additional Cases of PML Found Among Those Taking Tecfidera

 

Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.

 

According to the FDA drug label for Tecfidera approved on December 3, 2014, only one case of progressive multifocal leukoencephalopathy (PML) was found to be linked to the multiple sclerosis (MS) drug, Tecfidera (dimethyl fumarate), manufactured by Biogen, Inc.  

However, a fourth case was recently reported in December 2015, which led to an increased warning of this dangerous possible side effect of Tecfidera. Attorney Tom Lamb discusses the FDA's warning in his recent article, "A Tecfidera Label Change Modifying Warnings About Progressive Multifocal Leukoencephalopathy (PML) Was Done In February 2016 With Little Notice."

The first three cases of Tecfidera-induced PML occurred among patients with prolonged severe lymphopenia (low lymphocyte count), but Kristina Fiore reports in her MedPage Today article that the most recent case occurred among "a patient with only moderate lymphopenia...raising new questions about the drug's safety" (emphasis added).

Of note, these initial cases "occurred in patients treated with dimethyl fumarate who had not previously received other drugs, such as [Tysabri] natalizumab, known to be associated with a risk for PML" according to "New EMA Advice on PML Prevention With Dimethyl Fumarate (Tecfidera) in MS."  

Though the most recent case involved a patient who was previously treated with Tysabri, she stopped such treatment two months prior to starting Tecfidera, and was diagnosed with PML just shy of two years later, as discussed in this MedScape article.  Additionally, Fiore states in her aforementioned article that "the company said that prior exposure wasn't considered a confounder in this case."  

This goes to show that even though Tecfidera is typically regarded as one of the "safer" immunosuppressant agents, it still has the potential to cause dangerous adverse side effects.

As a precautionary measure, the European Medicines Agency encourages doctors to continuously monitor the lymphocyte counts of their patients, and check for the presence of JC virus infection before they consider prescribing Tecfidera.  

We will continue to monitor the medical literature concerning the link between Tecfidera and PML, and report on any new cases of PML that arise due to Tecfidera treatment.

 

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Biogen's Tecfidera sales miss estimates; confirms first PML case

Quoted from http://news.yahoo.com/biogen-profit-surges-tecfidera-sales-shy-street-view-120731126--finance.html

Biogen's Tecfidera sales miss estimates; confirms first PML case

By Bill Berkrot
October 22, 2014

(Reuters) - Biogen Idec Inc said on Wednesday sales of its big-selling new multiple sclerosis drug Tecfidera fell short of Wall Street's lofty expectations, and the company confirmed a serious brain infection in a patient who took the oral medication, sending its shares 7 percent lower.

Biogen reported the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera patient, who had been part of a clinical trial and was taking the drug for 4-1/2 years.

The patient, who died of pneumonia, had been suffering severe lymphopenia, a low white blood cell condition, for more than three years, which Biogen said was a risk factor for developing PML.

Biogen, which has notified health regulators of the PML case, said 100,000 patients have taken Tecfidera.

[Article continues at original source]

Biogen says patient death unlikely linked to new MS drug

Quoted from http://www.reuters.com/article/2013/07/22/us-biogen-tecfidera-idUSBRE96L0UA20130722

Biogen says patient death unlikely linked to new MS drug

 

Mon Jul 22, 2013 5:48pm EDT

(Reuters) - The death of a patient who had taken Biogen Idec Inc's new multiple sclerosis drug, Tecfidera, was unlikely to be linked to the medicine, the company said on Monday. 

Biogen said it was made aware last week of the death of a 59-year-old woman who had been treated with Tecfidera, and that it was actively gathering facts about the case. 

Based on the circumstances of the case and the cause of death, "a link to Tecfidera is unlikely," said Biogen spokeswoman Kate Niazi-Sai. 

"The patient was not on Tecfidera at the time of death," she added.

[Article continues at original source]