Epoetin alfa
| Clinical data | |
|---|---|
| AHFS/Drugs.com | monograph |
| MedlinePlus | a692034 |
| Pregnancy cat. | Unknown |
| Legal status | ℞-only (US) |
| Routes | IV or subcutaneous |
| Identifiers | |
| CAS number | 113427-24-0  |
| ATC code | B03XA01 |
| DrugBank | DB00016 |
| UNII | 64FS3BFH5W  |
| ChEMBL | CHEMBL1201565 |
| Chemical data | |
| Formula | C815H1317N233O241S5 |
| Mol. mass | 18396.1 g/mol |
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Epoetin alfa (rINN) (
/ɛˈpoʊ.ɨtɨn/) is human erythropoietin produced in cell culture using recombinant DNA technology.[1] It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anemia, commonly associated with chronic renal failure and cancer chemotherapy. Epoetin is marketed under the trade names Procrit and Epogen. Its annual cost to U.S. patients is $8,447 per patient per year.[2]
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[edit] Adverse effects
Epoetin alfa is generally well-tolerated. Common side effects include high blood pressure, headache, joint-pain and clotting at the injection site. Rare cases of stinging at the injection site, skin rash and flu-like symptoms (joint and muscle pain) have occurred within a few hours following administration. More serious side effects, including allergic reactions, seizures and thrombotic events (e.g., heart attacks, strokes, and pulmonary embolism) rarely occur. Chronic self-administration of the drug by two individuals caused increases in blood hemoglobin and hematocrit to abnormally high levels, resulting in dyspnea and abdominal pain.[3] e
[edit] Controversy
The publication of an editorial questioning the benefits of high dose epoetin was canceled by the marketing branch of a journal after being accepted by the editorial branch highlighting concerns of conflict of interest in publishing.[4]
In 2011, author Kathleen Sharp published a book, Whistleblower’s story,[5] alleging drug maker Johnson & Johnson encouraged doctors to prescribe epoetin in high doses, particularly for cancer patients, because this would increase sales by hundreds of millions of dollars. Former sales representatives Mark Duxbury and Dean McClennan, claim that the bulk of their business selling epoetin to hospitals and clinics was Medicare fraud, totaling $3 billion.[6] In a lawsuit, Duxbury alleged his employer wrongfully terminated him in 1998. He lived in Gig Harbor, Washington. He was born on March 23, 1960 and died on Tuesday, October 13, 2009, at age 49, while his case was still in litigation.
[edit] See also
[edit] References
- ^ Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp.39-41.
- ^ Balancing innovation, access, and profits -- marketing exclusivity for biologics, Alfred B. Engelberg et al., N Engl J Med 361:1917
- ^ R. Baselt, Disposition of Toxic Drugs and Chemicals in Man, 8th edition, Biomedical Publications, Foster City, CA, 2008, pp. 547-549.
- ^ Hardell L, Walker MJ, Walhjalt B, Friedman LS, Richter ED (March 2007). "Secret ties to industry and conflicting interests in cancer research". Am. J. Ind. Med. 50 (3): 227–33. doi:10.1002/ajim.20357. PMID 17086516.
- ^ Maryann Napoli (October 5, 2011), Whistleblower’s story: New book reviewed, Center for Medical Consumers, http://medicalconsumers.org/2011/10/05/whistleblowers-story-new-book-reviewed/, retrieved 2012-02-12
- ^ Edwards, Jim (August 17, 2009), Drug Rep in $3B Procrit Case: "80% of My Sales Were Medicare Fraud"; Carried $400K in "Cash", CBS news, http://www.cbsnews.com/8301-505123_162-42842558/drug-rep-in-3b-procrit-case-80-of-my-sales-were-medicare-fraud-carried-400k-in-cash/, retrieved 2012-02-12
