Monday, February 25, 2013

Affymax, Takeda pull Omontys after fatal allergic reactions

Severe hypersensitivity reactions in Omontys patients prompted Affymax ($AFFY) and Takeda Pharmaceutical to recall all lots of the anemia drug, designed for use in dialysis patients. Some of the reactions were fatal, though it's unclear how many. The companies reported the deaths in percentage terms: 0.02% of more than 25,000 patients who have received their first Omontys injections.

Ten days ago, the dialysis provider Fresenius said it would stop expanding an Omontys pilot program, after seeing "infrequent" allergic reactions in patients after their first dose. A "small number" of those were serious, the company said in a letter filed with the Securities and Exchange Commission.

Now, Takeda and Affymax say the reported reactions occurred within 30 minutes after a patient's first dose. None of the reported reactions followed subsequent doses.

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