Harman Law is investigating complaints of serious injuries and deaths resulting from severe dehydration in patients taking the MS drug Tecfidera (dimethyl fumarate). Severe dehydration may lead to blood-clotting or thrombosis, stroke, renal failure, seizure, and shock, among other things.
Tecfidera is known to cause gastrointestinal disturbance. The Manufacturer of Tecfidera, Biogen Idec, went to great lengths to conceal and downplay the extent of those side effects, as alleged in a recently unsealed federal whistleblower lawsuit (also see Harman Law Whistleblower Practice). The complaint was filed on behalf of the United States, 28 individual states, and the District of Columbia.
In the complaint a Senior Products Manager for Biogen states that after the launch of Tecfidera, he was directed to hold a series of advisory board meetings with physicians to “calm down the [healthcare provider] community and our national advisors and convince them that the GI side effects were transient.” The former Biogen Products Manager goes on to state that he, along with Biogen’s Medical Director, had “concerns” about Biogen’s “improper use of unreliable data to address concerns about GI and flushing issues.”
The whistleblower complaint goes on to allege that in response to prescribing doctors’ concerns about GI side effects, Biogen illegally promoted the extended use of lower doses of Tecfidera. The FDA has not concluded that Tecfidera at those lower doses is effective in treating MS.
Reports indicate that, in addition to nausea and vomiting, Tecfidera can cause stage 3 to 4 diarrhea according to the definitions by the National Cancer Institute. Hospitalization is recommended for stage 3 diarrhea and stage 4 diarrhea is considered a life-threatening condition.
If you have experienced serious side effects or know someone who has died while taking or after taking the MS drug Tecfidera, contact the dangerous drug attorneys at Harman Law LLC to learn your legal rights and eligibility for compensation. We offer a no cost, no obligation initial consultation to patients and families of patients.