Feldman, Fox & Morgado is pursuing claims against the manufacturer(s) of the drug Procrit for the wrongful death of a client's husband. The FDA issued new warnings in 2010 regarding the dangerous side effects of Procrit and Aranesp and Epogen. These drugs are in the class of drugs called ESAs: erythropoiesis-stimulating agents. The FDA concluded that these drugs lead to blood clots, deep vein thrombosis (DVT) and can lead to pulmonary embolism and death. Amgen manufacturers Epoetin alfa that is marketed as Procrit.
The new FDA warnings are as follows:
"You may get blood clots at any time while taking Procrit (Aranesp and Epogen). If you are receiving Procrit and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus)."
In addition, the product guide now reads:
"Perisurgery: Procrit increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis."
Procrit information on the FDA Medwatch.
"The FDA is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy (REMS), to ensure the safe use of these drugs." See the complete Safety Announcement.
Read the Amgen Aranesp REMS.
Any physician prescribing Procrit must provide the patient with the Medication Guide. In addition, the physician and hospital must disclose the dangerous side effects to each patient prior to dosing or administering this dangerous drug. As recommended in the REMS, patients should be closely monitored for many weeks following the dosing of Procrit. This includes taking blood samples and ordering lab work, taking vital signs and monitoring for the development of blood clots. It is necessary for physicians to review the need to prescribing blood thinners, and as well should prescribe and order Iron supplements for each patient.
Unfortunately, physicians were not aware of the link between Procrit, blood clots and DVT before this new Black Box warning. Physicians and hospitals have ordered Procrit post-surgery for loss of blood without educating patients to the dangerous side effects of Procrit or properly monitoring for the development of blood clots.
If a family member or loved one has died as a result of pulmonary embolism, blood clots or DVT after a surgical event or injury and treatment at a hospital, contact the firm of Feldman, Fox & Morgado, PA to discuss your case. In some instances, the physicians and hospitals dosing ESAs may have also breached the standard of care and this matter can be explored as well.
