Abbott, FDA Warn About Possible Overdose Of Antiretroviral Kaletra In Children

Main Category: HIV / AIDS
Also Included In: Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 17 Aug 2007 - 1:00 PST

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FDA and Abbott Laboratories are warning health care providers to be cautious in prescribing Abbott's antiretroviral drug Kaletra to children after the death of an infant who received an accidental overdose of the drug, the AP/Forbes reports. Abbott in an Aug. 6 letter, which was posted on FDA's Web site on Tuesday, said that children should receive no more than a five milliliter dose of Kaletra. The infant who died received a 6.5 milliliter dose (AP/Forbes, 8/14). According to Dow Jones/CNNMoney.com, the infant received an oral solution of Kaletra, which contains 80 milligrams of lopinavir and 20 milligrams of ritonavir per milliliter. Kaletra also is available in tablet form.

The letter will be distributed to health care providers to remind them about proper dosing of the drug for children. According to Abbott, the proper dose of Kaletra for children should be based on body weight (Corbett Dooren, Dow Jones/CNNMoney.com, 8/14). "Special attention must be paid to accurate calculation of the dose, transcription of the medication order, dispensing information and dosing instructions to minimize the risk of medication errors," Abbott said (AP/Forbes, 8/14).

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