FDA Warns Sarfez About Soaanz Promotional Materials
The CDER Office of Prescription Drug Promotion (OPDP) says promotional materials for Sarfez Pharmaceuticals’ Soaanz (torsemide) tablets for oral use make false or misleading claims and representations about the drug’s efficacy and risks. A 4/25 Warning Letter cites agency concerns about the company’s Web pages, pamphlet, and exhibit booth panel that were not submitted to OPDP at the time of initial dissemination as required by law.
The letter says the concerns about the materials’ false or misleading claims and representations “are especially concerning from a public health perspective because the promotional communications misrepresent both the efficacy and risk profile of Soaanz, a product with multiple Contraindications and Warnings and Precautions, that is indicated to treat edema associated with heart failure or renal disease in adults.”
OPDP says that in 5/6/2022 advisory comments, it addressed draft promotional communications for Soaanz. It says it is concerned that Sarfez continues to promote Soaanz as more favorable than other loop diuretics, including other torsemide products, when this has not been demonstrated, as well as failing to present the benefits and serious risks of the drug in a truthful and non-misleading manner, despite OPDP’s prior comments.
The letter cites examples of what OPDP says are false and misleading claims and presentations and says FDA is not aware of evidence to support representations and suggestions that pharmacologic differences between Soaanz and other loop-diuretic class drugs, including torsemide, result in clinically meaningful differences in diuresis, electrolyte abnormalities associated with loop diuretics, or natriuresis.
OPDP also says the exhibit panel contained benefit claims but failed to include any risk information about the drug, while statements in the Web page and pamphlet “undermine the serious risks of dehydration, blood volume reduction, hypotension, and worsening renal function associated with Soaanz.”
Sarfez was told to respond and address the concerns described in the letter, listing all other Soaanz promotional materials that contain the same or similar representations and explaining its plan for the timely discontinuation of such communications or to stop distributing the drug. Sarfez is also to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective communications about the concerns in the letter to the audiences that received the violative communications.