Procrit: Products Liability Claims And Wrongful Death

“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. You can also read Procrit information on the FDA Medwatch.

In February 2010, the FDA issued Black Box Warnings for all ESA drugs. These drugs were regularly prescribed to patients to build red blood cells following surgery and cancer treatment.

If your loved one died from complications after being prescribed an ESA, contact a Florida ESA wrongful death attorney at Feldman Legal Group at 877-946-8293 today.

The FDA notes that complications include:

“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). The common names used to market the ESA drugs: Epogen, Procrit, and Aranesp.”

If you have lost a loved one following surgery where they were prescribed an ESA drug, the death may have been caused by that drug.

What Is an ESA drug?

ESAs, or erythropoiesis-stimulating agents, are manufactured in two variations: Epoetin alfa and Darbepoetin alfa. Epoetin alfa, marketed as Procrit, is manufactured by Janssen, while Amgen manufacturers Aranesp (darbepoetin alfa) and Epogen (epoetin alfa).

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What Is the REMS for ESA drugs?

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, as well as prescribing and ordering iron supplements for each patient.

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:

“Pre-surgery: Procrit increased the rate of deep venous thrombosis in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.”

Federal Actions Related to ESAs

“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.

The Food and Drug Administration has called on doctors to scale back their dosing of ESAs. This class of medications, including Procrit, is used to treat anemia often stemming from chemotherapy treatment in cancer patients. These drugs work by stimulating a patients’ bone marrow to produce more red blood cells. The FDA has said that high doses of the drugs carry an increased risk of heart attack, stroke and other cardiac events. Therefore, the FDA has recommended prescribing the lowest possible dosage to improve the patient’s red blood cell count.

What Are Physician Requirements When They Prescribe ESAs?

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 as to 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 a Tampa attorney for ESA cases at the firm of Feldman Legal Group. We offer free assessments.