Vidyya Medical News Service
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Volume 6 Issue 61 Published - 14:00 UTC 08:00 EST 1-Mar-2004 Next Update - 14:00 UTC 08:00 EST 2-Mar-2004
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Botulism IGIV approved for infants

FDA recently approved the first drug to treat botulism in infants under one year of age. The new product is Botulism Immune Globulin Intravenous (Human), and will be sold under the trade name, BabyBIG. It can be used for both type A and type B botulism.

In clinical studies, when BabyBIG was given within the first 3 days of hospitalization, it significantly reduced the length of hospital stay in infected infants. It also reduced the average length of stay in the ICU and the average length of time on a ventilator. Keep in mind, though, that BabyBIG has only been studied in infants under one year of age, so it's not known if the drug would be safe and effective for other age groups.

It's important to remember that IGIV products of this kind may be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. IGIVs that contain sucrose as a stabilizer, such as BabyBIG, have accounted for a disproportionate number of these events. These events are rare, and no cases of renal failure were seen during the trials. Still, patients predisposed to acute renal failure should receive BabyBIG at the minimum concentration available, and at the minimum rate of infusion feasible. These patients include those with any degree of pre-existing renal insufficiency, diabetes, volume depletion, sepsis or paraproteinemia, and also those on drugs that are known to be nephrotoxic.


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