Executives at Lantheus Medical Imaging say they are surprised that the U.S. Food and Drug Administration (FDA) has included the North Billerica, MA, company's Definity echocardiography contrast agent on a list of pharmaceuticals being evaluated for safety issues.
On September 5 the FDA issued a list of 20 pharmaceuticals for which the agency identified potential safety issues during the first quarter of 2008. The list includes a variety of drugs such as Oxycontin and Cymbalta and can be viewed on the FDA's Web site. For Definity, the list identifies "cardiopulmonary reactions" as the "potential signal of serious risk" for the product.
"The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk," the Web site states. "It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk."
The pharmaceutical safety list is a new initiative designed to alert the public to pharmaceuticals that the FDA has identified as having "potential signals of serious risks/new safety information" under the agency's Adverse Event Reporting System (AERS). The list reflects FDA actions from January 2008 through March 2008.
The FDA was evaluating Definity during that period due to the agency's decision in October 2007 to require Definity and another echo contrast agent, Optison from GE Healthcare of Chalfont St. Giles, U.K., to carry black box warnings in their product labeling information. The agency took the action after receiving reports of deaths and serious reactions following echo contrast administration.
The new list apparently reflects the FDA's actions following the implementation of the original black box warning, rather than any new information about Definity, according to Dr. Mark Hibberd, senior medical director of global medical affairs at Lantheus
"Earlier this year following the labeling change, there were evaluations for Definity and other agents during the first quarter of the year; that's why it made the list," Hibberd said. "It didn't make the list because something new has happened during 2008."
Hibberd said that Lantheus was surprised by Definity's inclusion on the list, especially because there have been no new developments regarding the product's safety profile since a series of meetings in May 2008 resulted in changes to the labeling information for Definity and Optison. Definity's presence on the list is even more confusing, Hibberd said, because the list doesn't include Optison.
"We were surprised to see it [on the list] because the evaluation of potential safety issues with Definity, and for that matter with other similar products, has been done already, and a plan is in place," Hibberd said. "It's old news to bring to the attention of the public the fact that the FDA is evaluating these products and has made some conclusions about them."
GE spokesperson Brian McKaig said that GE believes that Optison was not included on the list because there were no adverse event reports on Optison during the first-quarter period covered by the safety list. GE resumed shipments of Optison in November 2007 after resolving good manufacturing practice (GMP) issues at the agent's manufacturing facility.
"There are no reports on Optison [during the period] and that's why Optison is not on the list," McKaig said.
Looser labeling
The FDA has eased up somewhat on its labeling requirements for both Definity and Optison, following a meeting with members of the echo contrast community in May. The FDA in July enabled Lantheus and GE to remove a number of contraindications from the labeling of their products, stating that for some patients the benefits of the diagnostic information that could be obtained through the use of Definity or Optison outweigh the risk of serious cardiopulmonary reactions.
Hibberd said that the fact that Definity has been included on the new safety list may cause some confusion for healthcare professionals regarding the product's safety profile. The company is planning to communicate with providers regarding Definity's status to clear up any misunderstandings.
"We are prepared to speak to healthcare providers to answer questions about this and to clarify any concerns they have," Hibberd said. "The healthcare community should understand that this refers to a situation earlier this year that has been effectively resolved."
Lantheus is continuing its effort to collect outcomes data under a patient registry called Contrast Echocardiography REgistry for Safety Surveillance (CaRES), which tracks potential adverse events following Definity administration. Since launching the registry in February 2008, researchers have collected data on several hundred patients, and very few adverse events have been reported, even minor ones, Hibberd said. Researchers are planning to publish data from the registry later this year or in 2009.
By Brian Casey
AuntMinnie.com staff writer
September 8, 2008
Related Reading
FDA formally updates echo contrast black box warning, July 18, 2008
FDA ultrasound contrast safety meeting sparks discussion, hope for the future, July 10, 2008
More study of heart imaging agent risks urged, June 25, 2008
Concerns remain over heart imaging agents: U.S. FDA, June 20, 2008
GE revises Optison's prescribing information, June 11, 2008
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