Smoking ? Since the initial launch of the product in 2012, more than 25,000 patients have been treated with Omontys.
"To date, fatal reactions have been reported in approximately .02 percent of patients, following the first dose of intravenous (IV) administration," Orwin said. "The reported serious hypersensitivity reaction have occurred within 30 minutes after such administration of Omontys. Three cases of serious anaphylactic reaction associated with fatal outcomes were reported in February."
Prior to February, two deaths were reported but were deemed to be "cardiovascular in nature."
"In these two cases, patients symptoms were not consistent with hypersensitivity reactions and in consultation with outside experts these events at the time were not considered likely to be results of drug-related hypersensitivity. These cases were reported to the Food and Drug Administration in accordance with regulations," Orwin said.
All cases are being considered during the recall and investigation. Orwin said that the cases that have occurred, occurred on a "first-dose phenomenon" and only with an IV administration of the drug.
"In the post -marketing setting, there have been no reports of such reactions following subsequent dosing in patients who have completed their dialysis session or in patients receiving the drugs subcutaneously—although the subcutaneous patient numbers are limited," Orwin said.
The case is being investigated and currently there is no timing on the next steps of the investigation.
MedWatch Online Voluntary Submission Form 3500
Public reporting burden for this collection of information is estimated to average 36 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of the Chief Information Officer
1350 Piccard Drive, 420A
Rockville, MD 20850
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.