Tesaro, Inc.

Tesaro Accused of Failing to Reveal Substantial Health Risks Associated with its Drug  

According to the complaint, Tesaro, Inc. (TSRO) officials spoke promisingly about Varubi IV-an intravenous formulation of its existing oral version of Varubi-in the company's public filings, stating that Tesaro intended to establish the drug as part of the standard of care for the prevention of CINV.  On October 25, 2017, Tesaro announced that the U.S. Food and Drug Administration approved Varubi IV, calling it a "significant milestone" for the company and a "unique, easy-to-use option that fits well into the standard operating practices of a chemotherapy clinic or hospital."  It therefore came as a surprise when Tesaro announced on January 12, 2018, that it received reports of "naphylaxis, anaphylactic shock, and other serious hypersensitivity reactions… in the postmarketing setting, some requiring hospitalization" during or soon after the infusion of Varubi injectable emulsion.  Tesaro further revealed that it issued a Dear Healthcare Professional letter to ensure that patients and healthcare professionals are aware the drug's label had been updated.  On this news, Tesaro's stock fell $4.07 per share, or 5.85%, to close at $65.52 per share on January 16, 2018, and continues to decline.

 

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