Enfants concernés par le VIH | Kaletra
A baby dies of Kaletra® oral solution overdose: who’s responsible?
20 August 2007 (papamamanbebe.net)
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LA COURNEUVE, 20 August 2007 (papamamanbebe.net) — A 44-day-old baby died nine days after receiving a massive dose (10 times normal) of Kaletra® oral solution.
In France, this antiretroviral drug is not prescribed, even at normal dosage, for children under two years of age.
Abbott sent a letter to prescribers on 6 August (translated and distributed by the French regulatory authority, AFSSAPS), without explaining the circumstances of this death. The country, the parents’ situation, and the context for treatment have not been revealed by the pharmaceutical company. In addition, the letter went almost completely unnoticed by media and by health information web sites in Europe.
Families living with HIV:
denounce the silence and the opacity around this death, and
demande accurate information on the toxicity of antiretrovirals and their adaptation to the needs of children with HIV-positive mothers.
The Comité des familles pour survivre au sida (Committee of Families United to Survive AIDS) wrote today to the French AFSSAPS secretariat on pharmacovigilance and to the medical information service at Abbott so the circumstances and the responsibility of the laboratory and the doctors in this death may be brought to light.
If the benefit of post-natal preventive antiretroviral treatment is clearly established when maternal treatment is suboptimal, the toxicities of antiretrovirals taken during pregnancy or given to newborns are an important issue for all parents and future parents living with HIV and their partners, and require particular vigilance about recent molecules.
The Comité des familles [pronunciation: Ko-mee-tay day Fa-mee], based in the suburbs of Paris, France, is the first organization founded and run by families of diverse backgrounds living with HIV. Its statutes expressly forbid it from receiving funding from the pharmaceutical industry. Papamamanbebe.net is a web site by and for parents facing HIV. Learn more about the Comité des familles...