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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
TRANSMITTED BY FACSIMILE
Lonnel Coats, President
Eisai, Inc.
100 Tice Blvd.
Woodcliff Lake, NJ 07677
RE: NDA #21-790
Dacogen
®
(decitabine)
MACMIS #18000
WARNING LETTER
Dear Mr. Coats
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a
Patient Profile Card (DAC206) (card) for Dacogen
®
(decitabine) (Dacogen) submitted by
Eisai, Inc. (Eisai) under cover of Form FDA-2253. The card is misleading because it omits
and minimizes important risks associated with the use of Dacogen, overstates the efficacy of
Dacogen, and omits material facts about Dacogen. Thus, the card misbrands the drug in
violation of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. 352(a) and 321(n).
Cf. 202.1(e)(3)(i); (e)(5); (e)(6)(i), (xviii) & (e)(7)(i), (iii), (viii).
Background
According to its FDA-approved product labeling (PI):
Dacogen is indicated for the treatment of patients with myelodysplastic syndromes
(MDS) including previously treated and untreated, de novo and secondary MDS of all
French-American-British subtypes (refractory anemia, refractory anemia with ringed
sideroblasts, refractory anemia with excess blasts, refractory anemia with excess
blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1,
Intermediate-2, and High-Risk International Prognostic System groups.
Dacogen is contraindicated in patients with a known hypersensitivity to decitabine. The PI
includes warnings against the use of Dacogen in pregnant women and advises males who
are receiving Dacogen not to father a child while receiving treatment or for two months
afterwards.
The PRECAUTIONS section of the PI states (in pertinent part):
General
Treatment with Dacogen is associated with neutropenia and thrombocytopenia.
Complete blood and platelet counts should be performed as needed to monitor
response and toxicity, but at a minimum, prior to each dosing cycle. After