Mallinckrodt pulls radiotracer from market

Article

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.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
SNMMI: Emerging PET Insights on Neuroinflammation with Progressive Apraxia of Speech (PAOS) and Parkinson-Plus Syndrome
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
Related Content
© 2025 MJH Life Sciences

All rights reserved.