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Suprane, Colazal Need New Warnings on Heart, Lung Risks, FDA Staff Says

Mar 24, 2008 | Parker Waichman LLP

Some Food & Drug Administration (FDA) advisors are pushing for new warnings on the labels of Suprane and Colazal because of potential risks these drugs may pose when used in children. An FDA safety panel is scheduled to meet tomorrow to discuss the safety of Suprane and Colazal,  as well as other medications used in children.

Suprane, an anesthetic manufactured by Baxter International, has been associated with instances of cardiac arrest when it has been used in children. According to Baxter's website, Suprane is indicated as an inhalation agent for induction and/or maintenance of general anesthesia for inpatient  and outpatient surgery.  On December 15, 2006, the FDA approved an expanded indication of Suprane, allowing its use for the maintenance of anesthesia in infants and children, after induction with other agents and tracheal intubation.

According to documents posted on the FDA website, the agency has received three reports of cardiac arrest in children who were administered Suprane.  All of the children did eventually recover with treatment.  The FDA staff said it was possible the cases were associated with Suprane. However they also said each of the patients was being treated with other drugs that may cause cardiac arrest. Despite the uncertainty, the FDA reviewers said Suprane's label "should be revised to include cardiac arrest."

The label for Suprane already carries warnings about other cardiac problems including heart attacks, irregular heart beats and unstable blood pressure.

Colazal was approved by the FDA in July 2000 for the treatment of mildly to moderately active ulcerative colitis. At approval, Colazal was the first oral new chemical entity approved in ten years and the first new therapy approved in seven years by the FDA for this indication.   Colazal was one of Salix Pharmaceuticals Ltd.'s biggest selling drugs, but sales were hit hard in December because of the introduction of the introduction of generic competitors.  The FDA staff has recommended that Colazal add new warnings on heart and lung risks to match those now carried by other drugs in the same class.

The FDA periodically reviews the safety of medicines recently approved for pediatric use, as required by the Best Pharmaceuticals for Children Act of 2002. According to the agency, outside experts on the agency's Pediatric Advisory Committee will consider the recommend label changes on Tuesday.


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