Besides Hepatotoxicity, Progressive Multifocal Leukoencephalopathy, Renal Toxicity, And Other Safety Issues Have Surfaced Since Clinical Trials
Tecfidera (dimethyl fumarate) was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS).
In February 2016 a rare but potentially fatal neurological disorder, progressive multifocal leukoencephalopathy (PML), was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera.
A more recent major change came in January 2017, with this one adding liver injury to the Warnings and Precautions part, as seen in the current Tecfidera drug label (accessed 2/7/17):
5.4 Liver Injury
Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients....
From this January 25, 2017 article published by Reuters, "Possible liver injury added to label of Biogen MS drug", we get the news report about this new drug safety issue for Tecfidera:
The prescribing label for Biogen Inc's big-selling oral multiple sclerosis drug Tecfidera has been updated to include a warning of potential liver injury that could require hospitalization, the company said on Wednesday.
However, the updated label says signs of liver injury resolved when those patients stopped taking the medicine.
Tecfidera, the world's top-selling oral MS treatment, accounts for about a third of Biogen revenue. It had sales of $1.03 billion in the third quarter....
A Biogen spokeswoman said there have been 14 cases of liver injury reported out of some 230,000 patients treated with Tecfidera.
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We get additional background information and some commentary from this February 1, 2017 Medscape Medical News article, "Dimethyl Fumarate for MS: Liver Injury Warning Strengthened":
The prescribing information for the oral multiple sclerosis (MS) medication dimethyl fumarate (Tecfidera, Biogen) has been updated to include a warning of potential liver injury that could require hospitalization.
The new information notes that clinically significant cases of liver injury have been reported in patients treated with the drug in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment....
MS experts contacted by Medscape Medical News did not think the labeling change would make much difference to its use.
"The incidence of liver function abnormalities appears to be rare, but the new labeling informs prescribers that monitoring will be necessary," said Edward Fox, MD, MS Clinic of Central Texas, Round Rock. "I would expect that this will lead to more frequent laboratory testing early in the course of treatment, but would be very unlikely to affect prescribing patterns. Personally, it won't change what I have already been doing. Most disease-modifying treatments for MS, including all approved oral therapies, have labeling reflecting a risk of hepatic injury."...
But Mark S. Freedman, MD, Ottawa Hospital, Ontario, Canada, noted that this was another side effect to have shown up with the drug since it reached the market.
"Tecfidera is not the 'honey' it was reported to be from the clinical trials," he commented. "Progressive multifocal leukoencephalopathy and other opportunistic infections (herpes), hepatotoxicity, renal toxicity, and other issues have all surfaced since the trials were reported."
We will continue to monitor the medical literature and adverse event reports for significant cases of liver injury associated with the use of Tecfidera by MS patients.
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