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FDA Warns Of Risks To Babies From HIV Drug Kaletra

Law360 (March 8, 2011, 5:12 PM EST) -- The U.S. Food and Drug Administration issued new warnings last month for Abbott Laboratories' Kaletra after serious health problems were reported in premature babies receiving the oral anti-HIV drug.

A new warning on the Kaletra label approved by the FDA on Feb. 24 says premature babies should not be given Kaletra until 14 days after their original due date — not their actual date of birth — and that infants younger than 14 days of age should only receive the drug if a doctor believes the...
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