Title:
ESA Black Box Warnings
Presenter:
Mitchell Feldman, Attorney
Content:
What are the Black Box warnings?
In February of 2010, the FDA changed the warnings on the class of drugs called ESA's which are Procrit, Epogen, and Aranesp; 3 different brand names of the same drugs. These ESA's are drugs which physicians would use in situations where someone has lost blood, to raise their blood levels. It's an alternative to giving blood transfusions, supposedly, thought to be less risk of harm occurring to the patient.
Well, In February of 2010, the FDA changed the Black Box Warnings which are the warnings that the manufacturers are required to place on the product guide that a physician would see, and what a patient would see. These are also part of the medication guides that a physician would be required to hand out to the patient if they are dosed or given this drug. These Black Box Warnings are essentially the bible that every physician needs to know, every hospital needs to know, what are the dangerous side effects, what can happen to you, and also to give guidelines for use of these drugs, protocols, follow ups, and in this case, with these class of ESA's, the FDA determined there was a causal relationship between blood clotting occurring very quickly after dosing with an ESA. Black Box Warnings now require the physician to follow up and review for Anticoagulation Therapy, the use of blood thinners, and to immediately warn the patient of the risks of developing the Deep Vein Thrombosis and the blood clotting. These are now mandated in the product guide, the medication guide, and must be discussed between the patient and the physician at the time that it is given out.
Feldman, Fox & Morgado, P.A.
855-4-FFM-LAW
En Español: 813-200-7250
www.FightForTheInjured.com
