Drugs/Therapy

Tecfidera from Biogen Associated with Possible Liver Injuries

By Joie M Gahum | Update Date: Jan 26, 2017 09:40 AM EST

Warnings about the potential liver injury that could require hospitalization have been released by Tecfidera drug manufacturer Biogen Inc. The said oral drug is being used to treat sclerosis and has been discovered to bring potential liver injuries as a side effect of its use.

Reuters reports that Biogen Inc's Tecfidera presently includes in its prescription label a warning about the possible liver injuries that it may bring to its user. However, an updated label of the prescribed drug indicates that the signs of the injuries in the liver were resolved immediately after a patient stops taking the medicine.

Tecfidera is an oral drug that is being used to treat sclerosis. The drug also happens to account around one-third of Biogen Inc's company revenues. In the third quarter of 2016, it reached a total sale of $1.03 billion.

The latest liver injury information is now found in the warning section of the drug's website tecfidera.com. The said label changes were finalized by the U.S. Food and Drug Administration last Jan. 19 as confirmed by Biogen.

At present, there have been 14 cased of liver injuries observed from the 230,000 sclerosis patients that are being treated with Tecfidera. Biogen is scheduled to report its fourth-quarter results on January 26 and will discuss the implications of the new warning included in Tecfidera's labels.

Meanwhile, Biogen reportedly increased the U.S. price of the MS drug Tecfidera, Avonex and Plegridy by 8% each this January as reported by BizJournal. Parallel to the increase, Cambridge Biotec is also reportedly increasing the price of its top sclerosis treatments including Tecfidera. Prior to the January increase, Tecfidera, Avonex and Plegridy already increased its retail price by 4 percent late in December 2015 and five percent in May 2016.

With the recent revelations of the potential liver damage that the Tecfidera drug can bring to its users, Biogen is also expected to address the issue of the price hikes, in relevance to the risks that come with the consumption of the drug, in its upcoming fourth-quarter financial reports. 

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