“Another big implosion is taking place in the world of biotech and biohealth. Affymax Inc. (NASDAQ: AFFY) and Takeda Pharmaceutical announced over the weekend that they are going to voluntarily recall all lots of the Omontys injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions.
The reaction cited was anaphylaxis, which can be life-threatening or fatal. The companies have worked actively with the U.S. Food and Drug Administration (FDA), which has indicated its agreement with this decision. The companies also have issued a letter to health care professionals indicating that no new or existing patients should receive Omontys.
Affymax said that fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. These serious hypersensitivity reactions occurred within 30 minutes after such administration of Omontys. The companies said that there have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session….”
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