April 2005 "Dear Doctor" Letter Also Addressed an Increased Risk of AML
In late May 2005 the FDA warned patients of the risk of heart damage from Serono's multiple sclerosis drug Novantrone. In a MedWatch alert, the FDA said congestive heart failure, a potentially fatal condition, could occur either during Novantrone therapy, or months to years after termination of Novantrone therapy. The May 2005 MedWatch alert also included information about an increased risk of developing treatment-related leukemia due to Novantrone use.
An April 2005 "Dear Doctor" letter sent out by Serono, the drug company responsible for Novantrone, provided additional information concerning the risks of cardiotoxicity associated with Novantrone. The April 2005 Serono letter to doctors and other healthcare professionals also provided supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with Novantrone.
A pharmaceutical sector financial analyst, Karl-Heinz Koch, of Lombard Odier Darier Hentsch, opined that this new warning will likely have little impact on Novantrone sales:
The drug is burdensome already because it has a large side effect catalog.... It is only used in very severe cases anyway. I don't believe it will have a big effect on Serono or a large impact on the use of the drug.
A spokesman for Serono concurred about the impact of this new set of warnings on Novantrone sales; "We believe it is not going to have an effect on the product. The product is for very severe forms of MS, for people who have no choice," the spokesman said.
(Posted by: Tom Lamb)