Preliminary report of a toxicity study of hydroxyurea in sickle cell disease. French Study Group on Sickle Cell Disease.
OBJECTIVE
To evaluate the tolerance of hydroxyurea in children affected with sickle cell disease.


METHODS
Questionnaire study of French physicians likely to treat patients with sickle cell disease. Data were collected on 101 children with sickle cell disease, treated for a median of 22 months, 36 of whom were treated for more than three years. 13 children were younger than 5 years of age at inclusion.


RESULTS
Hydroxyurea was stopped for medical reasons in 11 patients: 6 failures, 1 pregnancy, 1 cutaneous rash, 1 leg ulcer, 1 lupus. Acute lymphoblastic leukaemia occurred in a girl treated for 1.5 months with hydroxyurea, this short interval arguing against a causative association. One 17 year old boy had paraparesis after 8 years of treatment.


CONCLUSIONS
No major short or medium term toxicity was related to hydroxyurea in this cohort of 101 children. However, the number of children treated for more than 3 years is too few to make firm conclusions on the long term tolerance of this drug.
de Montalembert
M
M
Site Transfusionnel, Hôpital Necker, 149 Rue de Sevres, 75015 Paris, France. Mariane.Demontal@nck.ap-hop-paris.fr
Bégué
P
P
Bernaudin
F
F
Thuret
I
I
Bachir
D
D
Micheau
M
M
D000293:Adolescent; D000328:Adult; D000755:Anemia, Sickle Cell / Q000188:drug therapy*; D000986:Antisickling Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D006801:Humans; D006918:Hydroxyurea / Q000009:adverse effects*; D007871:Leg Ulcer / Q000139:chemically induced; D008297:Male; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic; D017211:Treatment Failure
D000986:Antisickling Agents; D006918:Hydroxyurea