What Your Doctor May Not Be Telling You About Dacogen
What is Dacogen?
Dacogen was approved by the Food and Drug Administration to treat a condition called acute myelodysplastic (myel= from the spine or bone marrow + displastic= developing incorrectly) syndromes, a blood cell disorder that, if left untreated, can turn into leukemia.1 Dacogen is sold in the United States by Esai, Inc.2
Does Dacogen work? Are advertising claims about it true?
Studies have shown Dacogen has improved blood cell counts in a percentage of patients with acute myelodysplastic syndrome (AMS).3
In 2009, the Food and Drug Administration sent Eisai, Inc. a warning letter regarding a patient profile card the company had created and distributed on Dacogen. This card exaggerated results from the drug, claimed results that weren’t supported by research and minimized or omitted adverse effects of Dacogen.4
In the card presentation, Eisai claimed blood cell count response rates that were much higher than the actual rates in the study it cited. They also claimed response rates that weren’t supported at all, seriously overstating the effectiveness of Dacogen. While they emphasized the unsupported high claims of response rate, they failed to include that there was no statistically significant improvement in patients' progression to AML (leukemia) or death, which the FDA stated was a more important outcome than cell count responses alone.5
The card included a series of patient profiles that implied that patients taking Dacogen would experience recovery from fatigue and return to the normal activities in their lives. The FDA pointed out that there was no support for these claims, that no research showed Dacogen to have these effects on patients. The card made the claim that a proportion of patients were red blood cell “transfusion independent,” but failed to disclose that a percentage of those patients were already independent of transfusion before the study, incorrectly implying that Dacogen was responsible.6
The card encouraged the continued use of Dacogen “until disease progression” and failed to include important, required safety information, including specific guidelines for delaying or reducing Dacogen in patients experiencing liver impairment.7
The card itself did not include any of the required safety, side effects and risk information on Dacogen. Instead, a small line of type at the bottom advised the reader to “Please see accompanying full prescribing information and Important Safety Information.”8
What should I go over with my doctor before I decide to take Dacogen?
Some patients have a hypersensitivity to Dacogen and should not use it. Dacogen affects genes, so pregnant women should not use Dacogen. Women should not get pregnant while taking Dacogen, and men should not father children for at least two months after receiving Dacogen. Patients with liver impairment may be advised by their doctor not to take Dacogen.
Dacogen has some side effects, including anemia, neutropenia (a lack of white blood cells which are part of the immune system), thrombocytopenia (a lack of platelets in the blood), pulmonary edema (fluid in the lungs), gastrointestinal disorders and many more.9
What if I’m already using Dacogen?
Never stop taking a prescription medicine without discussing it with your doctor. If you have experienced any adverse effects, tell your doctor. Your doctor can help you evaluate the risks or benefits of using Dacogen and whether there is an alternative that might be better for you.
Learn everything you can about Dacogen before you start taking it.
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1 Food and Drug Administration approval letter 2 May 2006, http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021790s000_Dacogen_Approv.pdf
2 http://www.dacogen.com
3 Food and Drug Administration, Center for Drug Evaluation and Research, Approved Labeling (2 May 2006), http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021790s000_Dacogen_PrntLbl.pdf
4 Food and Drug Administration Warning Letter (6 November 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM190441.pdf; Forbes, Ruiz R., “Ten Misleading Drug Ads” (2 February 2010), http://www.forbes.com/2010/02/02/drug-advertising-lipitor-lifestyle-health-pharmaceuticals-safety_slide_11.html
5 Food and Drug Administration Warning Letter (6 November 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM190441.pdf
6 Ibid.
7 Ibid.
8 Ibid.
9 Food and Drug Administration, Center for Drug Evaluation and Research, Approved Labeling (2 May 2006), http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021790s000_Dacogen_PrntLbl.pdf