Despite the global approval of FDA to certain drugs that could supposedly help cure Multiple Sclerosis, the US Food & Drug Administration has recently warned patients and healthcare professionals of a potential link between the multiple sclerosis drug Tecfidera and liver injuries. Experts from Biogen Inc. says that Tecfidera use, the company's huge-selling oral multiple sclerosis drug, have seen a possible occurrence of liver injury that could require hospitalization. On the other hand, on its updated label, it was found that signs of liver injury were resolved when those patients stopped taking the medicine.
Tecfidera Can Cause Severe Liver Injuries
According to reports revealed by Reuters, Tecfidera is known to be the world's top-selling oral MS treatment. According to some reports, it was because of the said MS drug why the company had astounding sales of $1.03 billion in the third quarter. It was found that with regards to the liver injury information, the company claims that it is indicated in a warning section under prescribing information on Tecfidera's website. As of the press time, a Biogen spokeswoman has revealed that there have been 14 cases of liver injury reported out of some 230,000 patients treated with Tecfidera.
Biogen's Take On Liver Injury And Hospitalization
Meanwhile, as per Legal Herald, although the patients were said to have recovered, it was found that a number of patients' health condition have really required hospitalization. Furthermore, Biogen has even added that none of the liver problems led to liver failure, transplant or death. Accordingly, the warning indicated on the warning section under prescribing information, it notes that symptoms of liver injury can include significant increases in the serum level of aminotransferases and bilirubin. It was found that the warning has allegedly stated that clinically significant cases of liver injury have been reported in patients treated with Tecfidera in the postmarketing phase of the study.