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FDA panel to review safety of 16 drugs in children

Nov 15, 2006 |

A Food and Drug Administration panel is set to meet Thursday to discuss the safety review of 16 drugs, including flu drug Tamiflu, in pediatric patients.

The pediatric advisory committee will evaluate new and updated reports by the FDA staff that include information on the drugs' safety compiled over a year. The panel will then make recommendations that could include label changes or further investigation of adverse events.

The FDA isn't required to follow the panel's suggestions, but it usually does.

Although the panel was to issue an opinion on Tamiflu's label Thursday, on Tuesday its manufacturer, Roche Holding AG (RHHBY), said it would follow the FDA staff's recommendation in the report and update the label to warn patients of potential abnormal behavior during treatment, including delirium and hallucinations.

In its report, the staff said the label should be changed following a review that found 103 cases of "neuropsychiatric adverse events," including the death of a 14-year-old boy who fell after climbing on his condominium balcony's railing.

According to documents posted on the FDA Web site ahead of Thursday's meeting, eight drugs under review didn't raise any safety concerns. They include cholesterol-lowering medications Lipitor from Pfizer Inc. (PFE) and Zocor from Merck & Co. (MRK), Eli Lilly & Co.'s (LLY) cancer drug Gemzar, and Johnson & Johnson's (JNJ) Ditropan to treat bladder instability.

The other eight drugs either presented new unlabeled safety concerns or "other attributes," including labeled but "serious adverse events of interest" and past safety concerns, the FDA said.

Included in this group are Pfizer's Zyvox, GlaxoSmithKline PLC's (GSK) Zofran and Avandia, Forest Laboratories Inc.'s (FRX) Celexa, Novartis AG's (NVS) Trileptal, Wyeth's (WYE) Rapamune and Abbott Laboratories' (ABT) Norvir.

In an updated report for depression drug Celexa, the FDA staff identified three new cases associated with QT prolongation, which can cause a fatal arrhythmia, since August 2003. The FDA requested the review following a prior report that found a possible association between the drug and the problem in all ages.

"However, this updated review of three new cases didn't find any well-documented cases of QT prolongation associated with using regular doses of (Celexa) in pediatric patients," the FDA staff concluded.

On Pfizer's Zyvox, which is indicated for treatment of certain bacterial infections, the FDA staff found six unlabeled events of "cardiac nature" during the one-year review. The report, however, said the cases "cannot be definitively associated" with the drug.

In the report on epilepsy drug Trileptal, the FDA staff recorded 84 adverse events in children taking the drug in the year-long review. Those events included one death, 52 unlabeled and 31 labeled cases. The staff said the unlabeled cases were too few to "characterize any one adverse event as a potential safety signal."

On Wyeth's Rapamune, the investigation found 19 pediatric cases of adverse events, including two reports of fluid collection that develops between the lining of the heart and the heart itself, and one report of cerebral bleeding.
Rapamune is indicated for the prophylaxis of organ rejection in patients ages 13 or older receiving a renal transplant. The FDA staff, however, said the majority of children it studied were under 12 years of age.

The report found it was "premature" to determine if the drug "played a clear role" in the adverse events reported.
On Glaxo's Zofran, used to prevent nausea and vomiting associated with chemotherapy and radiotherapy for cancer, the FDA staff identified 20 adverse events over a year, including one death. The report said, however, that most patients had underlying conditions or were taking other medication, making it difficult to link the events to the use of Zofran.
In the review of diabetes drug Avandia, the staff found two adverse cases during the one-year period, one involving accidental ingestion and the other involving behavioral changes. It said there were too few reported events to draw any safety conclusion.

On Abbott Labs' Norvir, used to treat HIV patients, the review found 33 adverse events in children in a period of one year, including skin reactions, anemia and pancreatitis. There were three deaths, none directly related to the use of the drug, the FDA said, adding it didn't find any safety concerns.

In the reports, the staff said it will continue to monitor adverse events related to the drugs. The FDA panel will meet at the agency's headquarters in Rockville, Md.

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