NeutroSpec, a technetium-based radiotracer approved by the FDA for the diagnosis of equivocal appendicitis, has been yanked from the market and recalled from provider shelves after reports of death and other serious adverse effects shook FDA officials' confidence in the safety of the drug.
NeutroSpec developer Palatin Technologies and its marketing partner Tyco Healthcare Mallinckrodt announced the actions Dec. 19, following a meeting they had last week with the FDA. During the meeting, regulatory officials requested a recall of NeutroSpec from customer inventories, as well as an end to marketing, sales, and distribution of the agent until serious adverse effects, particularly the death of two patients stricken soon after the drug was administered, could be further reviewed.
The FDA plans to convene an advisory panel early next year to discuss the use of NeutroSpec. The addition of safeguards will be among the issues discussed, according to Palatin executives, who plan to present evidence supporting its continued use in the diagnosis of equivocal appendicitis. (FDA reviewers approved marketing of NeutroSpec for this application in July 2004.)
The advisory panel will also discuss the possible use of the drug for currently off-label applications, such as the diagnosis of osteomyelitis. The two deaths associated with NeutroSpec involved off-label administration to patients with severe underlying cardiopulmonary compromise.
"We do not believe this is at all widespread," said Carl Spana Ph.D., company cofounder, CEO, and president. "I think there is a good possibility of us coming out of the advisory panel in a very strong position and being able to reintroduce the product to the marketplace."
Editor's Note: How Spana hopes to convince the FDA to support a return of NeutroSpec to the market and why the company's regulatory woes have had only a minor effect on its share price will appear in the Jan. 9 issue of DI SCAN.