Drug developer Palatin Technologies Inc. said Monday that it is recalling its NeutroSpec medical imaging agent and suspending sales of the product until adverse events can be studied further.
The company said that the imaging agent, which had been approved by the Food and Drug Administration in July 2004 for imaging appendicitis, was linked to two deaths and several adverse events after being used for unapproved uses. Palatin said the deaths occurred in patients with heart problems.
At a meeting with the FDA on Dec. 15, the agency told Palatin and its marketing partner Tyco Healthcare Mallinckrodt the product should not be given to patients until a better understanding of the adverse events was complete.
The companies sent letters to doctors warning of the possible risk in November.
The FDA also said they would convene an advisory panel in 2006 to reconsider the use of the imaging agent.
NeutroSpec, Palatin’s only marketed product, has had sales of about $9.8 million since being launched in September 2004.