(CN) – Shareholders of biopharmaceutical company Tesaro Inc. claim in a class action that the company covered up health risks associated with a cancer drug until forced by the U.S. Food and Drug Administration to report the drug’s serious adverse effects.
The action was filed in the U.S. District Court for Massachusetts against Tesaro and several of its top officers on behalf of investors who purchased Tesaro stock from March 16, 2016 to Jan. 12, 2018.
Based in Waltham, Ma., Tesaro develops and markets cancer therapeutics and oncology supportive products, one of which is Varubi, an intravenous drug used for the prevention of chemotherapy induced nausea and vomiting.
According to the lawsuit, Tesaro announced the FDA’s approval for an oral version of Varubi in 2015, but allegedly withheld damaging information about the drug in quarterly reports and press releases.
This January, Tesaro announced updates made to the drug’s package insert which notifies users that “anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization.” The company also revealed that the reactions occurred during or soon after taking the drug, most within the first few minutes of administration.
The revelation caused Tesaro’s stock to fall $4.07 per share to close at $65.52 on Jan. 16.
The class is represented by Glen DeValerio and Daryl Andrews of Andrew DeValerio LLP in Boston, Mass.