FDA News/Product Recalls

Changes Made To Vaccine’s Prescribing Information

The Food and Drug Administration has made changes to the Adverse Reactions and Post-marketing sections of the RotaTeq (Rotavirus, live, oral pentavalent) vaccine’s prescribing information. The Adverse Reactions section was updated to include six cases of Kawasaki disease that were observed during the Phase III clinical trial. There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. The postmarketing section of the prescribing information was revised to reflect three reports of Kawasaki disease to the Vaccine Adverse Event Reporting System (VAERS) since licensure in February 2006. There is not a known cause and effect relationship between receiving RotaTeq (or any vaccine) and the occurrence of Kawasaki disease.

The FDA describes Kawasaki disease as a “serious, but uncommon illness in children that is not well understood. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart.” The FDA and the Centers for Disease Control and Prevention will continue to monitor the safety of RotaTeq and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq be reported to VAERS. To read more about the label change, visit www.fda.gov/cber/label/rotateqLBinfo.htm

Infant Formula With Iron Is Recalled

Abbott, in conjunction with the Food and Drug Administration (FDA), recently announced a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital.

The three lots of formula were recalled because they do not contain as much iron as indicated on the label. The formula was distributed in the United States between November 2006 and May 2007. Premature infants fed this formula for more than a month after discharge could be at increased risk of developing anemia due to insufficient iron intake. If parents have concerns about their baby’s health, they should contact their baby's pediatrician or healthcare professional. No other liquid or powdered Similac Infant formulas were affected.

The stock code and lot numbers for formula affected by this recall are as follows: Stock code number 59582 with lot numbers 46815D5, 47847D5 or 52023D5 printed on the outside carton and case and the lot numbers 44427X8, 4427X81 or 50005X8 printed on the bottom of the bottles. These lots were distributed in the US between November 2006 and May 2007. Consumers who purchased Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron from any of the lots mentioned above should contact Abbott’s Ross Products Division at 1-888-899-9182. Ross will make replacements free of charge. The impacted product is not used in hospitals. The press release can be accessed at www.fda.gov/oc/po/firmrecalls/abbott05_07.html.

Cerebral/Respiratory Stimulant Recalled

Spectrum and the FDA informed healthcare professionals of a nationwide recall of three lots (TS0225, UK0821, and VI1203) of Caffeine Citrated, Powder, Purified. The product was recalled because of complaints about potential subpotency, when blood levels of caffeine in patients were determined to be significantly lower than would be expected. Caffeine citrated is a cerebral and respiratory stimulant used primarily to treat “short-term idiopathic apnea” of premature infants between 28 and 33 weeks gestational age.

The use of subpotent compounded preparations may lead to subtherapeutic caffeine blood levels and an unacceptable risk of respiratory depression. Healthcare professionals should examine their inventory, discontinue dispensing and using the product, quarantine the referenced lots of the product, and call the manufacturer to return the product for credit or replacement. For more information, visit www.fda.gov/medwatch/safety/2007/caffeine_recall.htm.

Additional Safety Information Added To Iron Overload Drug

Novartis and the FDA have notified healthcare professionals of changes to the Warnings and Adverse Reactions sections of the product labeling for deferasirox (Exjade) tablets for oral suspension. The drug used to treat chronic iron overload due to transfusional hemosiderosis in patients 2 years of age and older.

Cases of acute renal failure, some with a fatal outcome, have been reported. Most of the fatalities occurred in patients with multiple comorbidities, and who were in the advanced stages of hematological disorder. There have also been reports of cytopenias, including agranulocytosis, neutropenia, and thrombocytopenia, but the relationship of these episodes to treatment with Exjade is uncertain. Most of these patients had pre-existing hematologic disorders that are frequently associated with bone marrow failure. Cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions (including anaphylaxis and angioedema) have also been reported. A copy of the “Dear Healthcare Provider” letter from Novartis is available at www.fda.gov/medwatch/safety/2007/Exjade_DHCPL_May2007.pdf.