Peginesatide pulled from the market

All lots of the injectable anemia drug peginesatide (Omontys) have been recalled, due to new postmarketing reports of serious hypersensitivity reactions, some fatal.

To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration, according to an FDA alert. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of the drug. There have been no reports of such reactions following subsequent doses or in patients who have completed their dialysis session.

More than 25,000 patients have received the drug, and hypersensitivity reactions have been reported in approximately 0.2%, with about a third of these categorized as serious, including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.

The drug should be returned to the manufacturers, Affymax and Takeda, the FDA said.