Abbott warns on risk of overdose with Kaletra liquid

Keith Alcorn
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This article is more than 17 years old.

Abbott, the manufacturer of the protease inhibitor Kaletra, has warned healthcare professionals about the risk of overdosing infants and small children when using the liquid formulation of Kaletra, following the death of an infant who was given ten times the recommended dose.

The death occurred after a 44 day-old infant was given 6.5ml of Kaletra oral solution, the equivalent of giving 520mg of lopinavir and 130mg of ritonavir. Each millilitre of oral solution contains 80mg of lopinavir and 20mg of ritonavir.

The infant died nine days later of cardiogenic shock.

Glossary

oral

Refers to the mouth, for example a medicine taken by mouth.

equivalence trial

A clinical trial which aims to demonstrate that a new treatment is no better or worse than an existing treatment. While the two drugs may have similar results in terms of virological response, the new drug may have fewer side-effects, be cheaper or have other advantages. 

paediatric

Of or relating to children.

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

Infants weighing 7kg -15kg should receive a dose of oral solution equivalent to a drug dose of 12mg/kg – 1.25ml twice daily for those wighing 7 – 10kg and 1.75ml for infants weighing more than 11 - 15kg. Dosing should be reviewed after each occasion on which an infant is weighed.

Abbott emphasises in a letter to health care professionals that Kaletra oral solution is highly concentrated, containing 80mg of lopinavir and 20mg of ritonavir per ml, not per bottle.

Errors in paediatric dosing may arise when the dose for the appropriate body weight is incorrectly calculated.

Abbott announced last month that a heat stable tablet version of Kaletra containing 100mg of lopinavir and 25mg of ritonavir is currently being reviewed by the European medicines regulatory body (EMEA) and by the US Food and Drug Administration. Abbott hopes that approvals will follow in developing countries; the paediatric tablet will cost $500 a year in countries already eligible for the low and lower middle income countries price reduction.

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