Epogen and Procrit Side Effects Linked to Death for Stroke Patients

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Preliminary data from a study funded by Johnson & Johnson’s Ortho Biotech unit found that individuals who were given Procrit (which is also marketed as Epogen) following an ischemic stroke had a greater incidence of death than those who received a placebo.

The study evaluated the side effects of Epoetin alfa, which is a drug marketed in the United States as Procrit by Johnson & Johnson’s Ortho Biotech and Epogen by Amgen. Outside the U.S. it is sold as Exprex or Erypo. Although the drug is not approved for treatment following an ischemic stroke, the data raises serious concerns about the potential side effects of Procrit, Epogen and other drugs containing Epoetin alfa.

Epogen and Procrit are anemia drugs that the FDA has approved for treatment of patients with chronic kidney failure who are undergoing dialysis, cancer patients under going chemotherapy, HIV patients whose anemia is caused by AZT (zidovudine) and for patients scheduled for major non-heart surgery, to reduce the number of transfusions. However, the drugs have been widely prescribed off-label for a number of uses.

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Johnson & Johnson released a statement yesterday disclosing the preliminary findings from an experimental study designed to evaluate the effects of Epoetin alfa in patients who suffered an acute ischemic stroke. Among patients who were given the drug within six hours of suffering from symptoms of stroke, data revealed that there was a higher rate of death than among those who had taken a placebo.

 
The U.S. FDA and European regulatory authorities have been notified about the findings, and Johnson & Johnson indicated in their statement that the drugs should only be used strictly in accordance with their approved indications and dosing recommendations.

Procrit and Epogen are members of a class of medications known as erythropoiesis stimulating agents (ESAs), which also includes Amgen’s Aranesp (darbepoetin alfa) . A number of concerns about potential side effects of these widely used drugs have emerged over the past two years.

In March 2007, the FDA added a “black box” warning to Epogen, Procrit and Aranesp about potential side effects which could increase the risk of blood clots, strokes, heart attacks or death when given at high doses. They have also been linked to an increased rate of tumor growth when given to patients with certain types of cancers.

The manufacturers of these drugs have also faced intense scrutiny surrounding the promotion of these drugs, which has led to wide overuse for unapproved conditions, such as symptoms of anemia. The drug makers have been accused of paying doctors hundreds of millions of dollars each year in return for prescribing the anemia drugs to their patients.

Tags: Anemia, Aranesp, Epogen, Johnson & Johnson, Procrit
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5 Comments

Anthony
My 92 year old has been anemic for many years a local doc. referred him to a hemotologist ,he received many 40k doses of procrit,with many terrible side effects rashes,swollen lower leg,rapid regrowth of tumors with mose surgery to correct it,,chest congestion,finally a trip to the ER. because of extreme bone n joint pain,then terrible bed sores from the hospitals neglect,I discovered later 40k units is 3 x the regular dose for anemia,,and after only one bad reaction the drug should not be given again,I trusted the doctor with my dads health,,now im giving him b12 shots at home & his blood #s are great,he went thru 1 1/2 years of terrible pain also hit has rapidly advanced his dementia because of this doctor & drug,patient’s beware please !!!!!
Kathryn
My husband, a kidney transplant patient, was given epogen and aranesp for anemia. After beginning treatment, he began to experience many difficulties. To name a few — poor coordination, illegible writing and a decreasing ability to compute simple math. He suspected these were somehow connected to the injections, but was told repeatedly by medical personnel that there were no problems with the drug. His symptoms worsened and after four months, he was admitted to the hospital for tests. I was told the MRI of his brain did not indicate a stroke, but an inflamation in the brain stem. He was sent to rehabilitation and continued to receive the arenesp injections. He became worse and experienced conjestive heart failure. After more tests I was told he had a large blood clot in the aortic arch which was pinging off small pieces and causing strokes. On March 11th, 2007 at age 64, my husband died -two days after the drugs were issued a black box warning by the FDA.
Beth
My mom is 68 and recently suffered a left lunar infarct within 48 hours of receiving a procrit injection for anemia. Then, to make matters worse, while she was being prepared to be sent to the ER for eval of the stroke, the RN administered a second injection of Procrit within 3 days of the 1st injection. She had no previous neuo history prior to this injection. Also, I worked for a group of Neurologists for 8 yrs, and I know that lunar infarcts are only caused by sudden, severe rise and fall of blood pressure. My mom has orthostatic HYPOtension (low blood pressure). Before the stroke, her BP was avg. 70/50. Immediately after the Procrit injection, her BP soared to 200/100. The doctors refuse to acknowlege the correlation and instead, are pushing to continue with the Procrit injections! This flies in the face of all sound medical judgement. In posting this, I hope I can prevent another person from suffering at the hands of the greedy pharmaceutical and medical industries. God bless all who read this.
FDA Reviewing Epogen and Procrit Side Effects After Study Identifies Risk of Death : AboutLawsuits.com
[…] an “Early Communication” about their ongoing safety review of a potential increased risk of death associated with Procrit and Epogen, which are used to treat […]
renee
This is a very informative and interesting article. It is very helpful to me in trying to decide whether or not to allow my DR to use this drug on me for my severe anemia.

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