FDA Warns Metuchen Pharma on Promotions
A just-released FDA Warning Letter cites Metuchen Pharmaceuticals over its promotional activities related to erectile dysfunction drug Stendra (avanafil) tablets. CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer print ad and display banners make false or misleading claims about the risks associated with the drug. The labeling does not provide adequate directions for safe and effective use of the product.
The letter says the ad includes the headline claim “Treat ED and Reduce Risk of Heart Failure with a PDE-5 Inhibitor,” which provides evidence that Stendra is intended for a new use for which it lacks approval. “Stendra is not approved for reducing the risk of heart failure, and its labeling does not contain adequate directions for such use, thereby rendering the drug misbranded,” FDA’s letter says. “This 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 [package insert] contains a warning and precaution regarding cardiovascular risks, and specifically states that Stendra is not recommended for patients with New York Heart Association Class 2 or greater congestive heart failure.”
The letter also says that the print ad and banners are misleading because they include claims or representations about the uses and benefits of Stendra, but fail to include important risk information associated with the drug. For example, the print ad includes several efficacy claims for Stendra, as well as a statement communicating the warning and precaution regarding alcohol and most common side effects of Stendra. “However,” the letter says, “the print ad fails to disclose any of the contraindications or other warnings and precautions associated with the product. By omitting risks associated with Stendra, the banners and print ad fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety. These misleading presentations are especially problematic from a public health perspective due to the multiple serious risks associated with the drug.”
OPDP’s letter requests that Metuchen immediately stop misbranding Stendra. The letter also tells the company to run corrective messages to the audiences that received the violative promotional materials. “To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated,” it says.