Washington, DC - The FDA has ordered Centocor, a division of Johnson & Johnson, to correct a series of statements on promotional materials for reteplase (Retavase®, Centocor) that have been found to "contain false and/or misleading claims about Retavase or its competing products." The claims in question involve misleading statements as to safety and efficacy and a dosing chart comparing reteplase with tenecteplase and alteplase that exaggerates the complexity of dosing the other two drugs.
In terms of safety and efficacy, the FDA objects to the claims "RetavaseEfficacy Confirmed in GUSTO V" and "RetavaseSafety Confirmed in GUSTO V." Both are false and/or misleading because GUSTO V did not provide substantial evidence for efficacy of either the reteplase or the reteplase and abciximab arms. Also, "the GUSTO V trial data do not constitute substantial evidence or substantial clinical experience," according to the FDA.
The FDA said the statement "Superior Reperfusion in AMI" under the Retavase logo falsely implies that reteplase is superior to all reperfusion therapies in AMI, which is not proven.
A claim of superiority vs tPA in restoring TIMI 3 flow is considered misleading because it does not specify which tissue plasminogen activator reteplase is superior to.
The FDA also said it is unaware of any data establishing that the molecular design of reteplase correlates with the speed and safety of reperfusion and therefore Centocor must change its claims of a "Unique Molecular Design for Rapid and Safe Reperfusion." The FDA would accept the "Unique Molecular Design" as a description of reteplase.
In all cases of missing data, Centocor has until the end of June to provide data confirming the claim to the agency. In absence of such data, the company is instructed to respond with details on how and when it will discontinue the misleading materials.
A spokesperson for Centocor told heartwire , "We are going to work with the FDA to resolve these issues." Centocor needs to examine the letter's comments and then decide how to respond to the FDA, the spokesperson said.
Heartwire from Medscape © 2003
Cite this: FDA orders Centocor to change reteplase claims - Medscape - Jun 05, 2003.