AFFY:Unusual news from the weekend in the healthcare sector came out of Affymax (AFFY) after voluntarily withdrawing all lots of their only product, Omontys. There have been 19 reports of fatal reactions in patients following the first dose of intravenous use, leading to 3 deaths amongst the affected patients.
So far, management has not identified the cause to these fatal reactions. Since their clinical trials, which received FDA approval in March 2012, approximately 27,000 patients have received Omontys. Therefore, in more than two years time (during clinical trials and post launch), there had not been any fatal reactions to the use of Omontys. The FDA found the drug to be safe enough for approval. Suddenly, 3 deaths occur due to the administration of the drug in a matter of a month.
An explanation for such highly coincidental possibilities can be an issue in the manufacturing of the drug or even matters other than the drug itself.