[Evaluation of the pharmacovigilance follow-up of zidovudine].
A therapeutic committee was established in Toulouse Regional University Hospital in order to prescribe zidovudine in patients suffering from AIDS. Using an informatic card, the side effects were evaluated in the 125 patients treated by Zidovudine since the creation of the Committee (from July 1987 to January 1989). Zidovudine was prescribed from May 1987 to June 1988 at the total dose of 1,200 mg daily from June 1988 at 900 mg daily. The most frequent side effects were hematologic: zidovudine used alone (or associated with non hematotoxic drugs) elicited in 21.2% of patients a neutropenia (defined as a number of neutrophils less than 1,000/mm3), in 2.4% anaemia (haemoglobin less than or equal to 9 g/100 ml) and in 4.8% neutropenia associated with anaemia. When zidovudine was administered with hematotoxic drugs, neutropenia, anaemia or the association of both were observed in 12.0%, 3.2% and 2.4% of patients respectively. These hematologic side effects were always regressive after drug cessation. However, it is important to underline the low incidence of hematological side effects on red cells of zidovudine in the present study. This result is unexpected. The other side effects of Zidovudine (used alone) did not led to modification in drug treatment: gastrointestinal disturbances (30.4%), headaches (16.8%), insomnia (13.6%), somnolence (6.4%).... These side effects appeared during the four first months and decreased with the continuation of drug treatment. Their imputation was difficult to define and differentiate to evolution of the disease.
Gimenez
S
S
Hôtel Dieu, Toulouse.
Bagheri
H
H
Marchou
B
B
Massip
P
P
Lafont
J
J
Sorbette
F
F
Armengaud
M
M
Montastruc
J L
JL
D003201:Computers; D005500:Follow-Up Studies; D005602:France; D006785:Hospitals, University; D006801:Humans; D011358:Product Surveillance, Postmarketing; D015215:Zidovudine / Q000009:adverse effects*
D015215:Zidovudine
Bilan d'un suivi de pharmacovigilance de la zidovudine.