Sept. 9, 2019 – In its first Warning Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP), continues to call out the omission of risk information cited in previous Untitled Letters this year, stating that Metuchen Pharmaceuticals LLC’s direct-to-consumer (DTC) print ad and display banners for its erectile dysfunction (ED) drug include claims about the benefits of the drug but fail to include important risk information, among other issues.
In the Aug. 14 Warning Letter, OPDP notes that a DTC print ad for Stendra® (avanafil) tablets, approved to treat ED, “includes several efficacy claims for Stendra, as well as statement communicating the warning and precaution regarding alcohol and most common side effects of Stendra. However, the print ad fails to disclose any of the contraindications or other warnings and precautions associated with the product.”
Claims made in the display banners are similarly described, with OPDP also stating that several efficacy claims made in one banner “fail to communicate any risk information about the product’s safety, [and] create a misleading impression about the product’s safety, which is further exacerbated by the efficacy claim.” OPDP also states that although another banner includes a statement about common side effects of the drug, it fails to include “any of the contraindications or warnings and precautions of the drug, creating a misleading impression about the safety of Stendra.”
OPDP also remarks in the letter that although the ad and banners include statements such as “Ask your doctor for more information” and “Learn more at BIT.LY/STENDRA,” these statements “do not mitigate the misleading impressions regarding Stendra’s safety created by the omission of risk information from the banners and print ad.”
Further, the print ad includes a headline claim – “Treat ED and Reduce Risk of Heart Failure with a PDE-5 Inhibitor” – which, according to OPDP, “provides evidence that Stendra is intended for a new use for which it lacks approval and for which its labeling does not provide adequate directions for use.” This claim, OPDP asserts. “is especially concerning from a public health perspective given that the PI 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 heart failure.”
A claim in the print ad states that Stendra is “safe and effective for those with heart disease,” which is false and misleading, according to OPDP, because there are groups of patients with heart issues for which the drug is not recommended. OPDP also takes issue with a claim that Stendra is the “next generation” ED drug, which implies that the product is safer or more effective than its competitors.
“Promotional materials are also misleading if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information related to the efficacy of the drug” the Warning Letter states. In this case, the print ad presents efficacy information in “large, bolded font size and colorful graphics surrounded by a significant amount of white space,” while the “limited” risk information is presented in “much smaller font size, surrounded by little white space, and in single-spaced format at the bottom of the ad.”
Finally, a banner claim about the use of Stendra fails to specify that the product is meant for individuals with ED, not for those who do not have the condition. “The omission of the indication is particularly concerning from a public health perspective due to the serious health risks associated with Stendra,” OPDP states.
Thus far in 2019, OPDP has issued a total of five enforcement letters – one Warning Letter and four Untitled Letters. It issued seven enforcement letters in 2018.