Contrast agent developer Palatin Technologies said it is voluntarily suspending sales, marketing, and distribution activities of its NeutroSpec radiopharmecutical imaging agent as a result of recently raised safety concerns. The Cranbury, NJ-based firm is also recalling all existing customer inventories of NeutroSpec, which is designed for imaging equivocal appendicitis.
As a result of the previously reported serious adverse events, including two deaths, involving patients with severe underlying cardiopulmonary compromise that had received NeutroSpec for off-label uses, Palatin and marketing partner Mallinckrodt had proposed revised labeling for NeutroSpec to the FDA.
At a December 15 meeting with the FDA, the agency had informed the firms that it had reconsidered the risk/benefit assessment of NeutroSpec, and that it has determined that the product should not be administered to patients until a further understanding and review of the relationship between NeutroSpec and the serious events is complete. Although the firms said they believe that these safety concerns could be addressed in other ways, they've voluntarily agreed to take the actions requested by the FDA.
The FDA will be convening an advisory panel early next year to discuss the use of NeutroSpec with additional safeguards and evidence needed to continue use of the product for equivocal appendicitis, as well as plans for other indications, including osteomyelitis, Palatin said.
By AuntMinnie.com staff writers
December 19, 2005
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Mallinckrodt, Palatin extend partnership, June 6, 2005
Palatin reports higher sales, lower net loss, May 10, 2005
Palatin nets Medicare reimbursement code, January 24, 2005
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