Any further safety concerns could hinder ultrasound contrast agent delivery, manufacturer warns
Publicly traded Lantheus Holdings Inc. is warning investors that a recent U.S. Food and Drug Administration safety alert could impact the use of its signature ultrasound contrast agent.
The North Billerica, Massachusetts-based firm shared its forecast in a quarterly financial report published Tuesday. Lantheus acknowledged an FDA warning related to Definity — along with competitor Bracco’s version of the injectable imaging enhancement, Lumason — following several severe allergic reactions to the drugs and two deaths.
If additional safety issues arise, the feds may force “unfavorable” changes in labeling, restrictions on the product’s approval, or its removal from the market, Lantheus said.
“Lingering safety concerns about Definity among some healthcare providers or future unanticipated side effects” could potentially limit expanded use, company officials wrote in the May 4 filing with the Securities and Exchange Commission. Such a scenario, they added, might produce “a material adverse effect” on both sales and the firm’s fiscal condition.
Lantheus also reported its first quarter financials May 4, highlighting a “strong” start to 2021, with solid revenue and earnings mainly driven by Definity. Sales of the contrast agent hit $56 million, 6.6% higher than the same three months in 2020. President and CEO Mary Anne Heino said ultrasound heart-scan volumes appear to be returning to pre-COVID levels and labeled echocardiography as a 35 million procedures-per-year market that’s growing 2%-3% annually.
The FDA first issued its safety warning on April 22 after 11 cases of anaphylaxis and 2 deaths that appeared related to Definity or Lumason. The two drugs contain polyethylene glycol or “PEG,” which is derived from petroleum, and providers should not administer them to patients with known or suspected allergies to this compound, the FDA said.
Following the safety warning, the International Contrast Ultrasound Society urged providers to continue using these agents, estimating that allergic reactions occur in 1 of every 10,000 doses. In its own statement May 3, the American Society of Echocardiography also endorsed continued use because the risk-to-benefit ratio remains “extremely low.” The society did not advocate for any changes to laboratory policy following the MedWatch alert.
Bracco did not respond to a Radiology Business request for comment on the FDA alert, while Lantheus issued a brief statement Wednesday.
“We believe the responses from the International Contrast Ultrasound Society and the American Society of Echocardiography accurately characterize the continued diagnostic value and safety of ultrasound enhancing agents and Definity’s well-documented safety profile established over two decades of use in more than 14 million echo studies,” Lantheus said May 5.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.