FDA's OPDP Warns Metuchen Pharmaceuticals Over Misleading DTC Ads

Regulatory NewsRegulatory News
| 26 August 2019 | By Zachary Brennan 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Metuchen Pharmaceuticals earlier this month for several false and misleading advertisements for its erectile dysfunction drug.

In several print and online ads, including one in the American College of Cardiology’s magazine, the drug, known as Stendra (avanafil), is portrayed as being approved for a new use for which it lacks approval, and several misleading claims are made that fail to include risk information.

The print ad, for instance, says Stendra can: “Treat ED and Reduce Risk of Heart Failure with a PDE-5 Inhibitor” and that “Stendra is the next-generation, PDE-5 inhibitor that improves erectile function.” But FDA notes that this first claim, “which misleadingly suggests that Stendra is safe and effective for a use for which it is not approved and for which you have provided no evidence to support, is especially concerning from a public health perspective given that the PI [product information] contains a warning and precaution regarding cardiovascular risks.”

And although FDA concedes that there is evidence that PDE-5 inhibitors, including Stendra, may be safe and effective for men with some types of heart disease, FDA again notes that the PI for Stendra “contains a warning and precaution for cardiovascular risks associated with the drug.”

The print ad also fails to disclose any of the contraindications or other warnings and precautions associated with the product, FDA says.

The online ads, which were displayed on adult and other websites, create a misleading impression about the product’s safety and that the product can be used at any time, which is not the case, FDA adds. Other claims were misleading because they fail to communicate material information regarding the indication for Stendra.
OPDP requests that Metuchen immediately cease misbranding Stendra and it also seeks a written response by Friday.

Metuchen CEO Greg Ford told Focus via email: “We have received the FDA letter and will be responding and addressing the FDA’s concerns.”

This is OPDP's first warning letter of the year. The office has also issued four untitled letters this year.

Warning Letter



© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy