Maker of “Female Viagra” Deceives Women With Misleading Radio Ad

In an effort to resurrect sales of flibanserin (ADDYI) — a drug intended to increase sexual desire in premenopausal women with hypoactive (low) sexual desire disorder that is often erroneously dubbed the “female VIAGRA” — Sprout Pharmaceuticals has engaged in aggressive direct-toconsumer marketing of the drug.[1],[2]

But according to a Food and Drug Administration (FDA) warning letter sent to Sprout in August, the company’s marketing blitz has included the airing of an illegal radio ad that made “false or misleading claims about the risks associated with Addyi” and omitted key information regarding the scope of the drug’s approved use.[3]

We have designated flibanserin as Do Not Use because its life-threatening risks far exceed its extremely minimal benefit. Notably, the product labeling for flibanserin includes a black-box warning — the strongest warning that the FDA can require — indicating that the drug can cause severe hypotension (low blood pressure) and syncope (fainting), especially in patients who recently consumed alcohol, have liver problems, or take certain other prescription medications.[4] These adverse effects may lead to serious accidents or injuries.

The FDA’s warning letter first admonished Sprout for omitting from the radio ad essential risk information found in the black-box warning for flibanserin, thus creating a misleading impression of the drug’s safety.[5] For example, although the ad presented some information about the risk of low blood pressure and fainting in certain settings, it failed to mention that use of the drug soon after consuming alcohol increases the risk of severe hypotension and syncope. Likewise, the ad failed to disclose that use of flibanserin with certain other prescription drugs or in patients with liver problems heightens these same risks.

The FDA also warned Sprout for airing an ad that created “a misleading impression regarding the scope” of the drug’s approved use and its effectiveness. The agency cited the following problematic claims: “1 in 10 premenopausal women suffer from frustrating low libido, also known as HSDD [hypoactive sexual desire disorder]… Meet Addyi — the first and only FDA-approved non-hormonal pill for…HSDD in premenopausal women. In other words: An FDA-approved pill for women frustrated by their low libido.” The FDA found these claims to be particularly troubling because they falsely suggest flibanserin is approved for “all women ‘frustrated by their low libido’ when this is not the case.”

The FDA requested that Sprout release new ads that corrected each misleading statement. For some women, however, these corrections will come too late or will be missed. To prevent the harm caused by such illegal ads, Congress must grant the FDA the authority to review and approve all direct-to-consumer TV and radio ads before they air.
 

References

[1] Sprout Pharmaceuticals. Addyi (flibanserin). https://addyi.com/. Accessed September 29, 2020.

[2] Avoid the ‘pink pill’ flibanserin (ADDYI) for low female sexual desire. Worst Pills, Best Pills News. April 2020. /newsletters/view/1326. Accessed September 29, 2020.

[3] Food and Drug Administration. Warning letter to Sprout Pharmaceuticals, Inc. August 31, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-610569-08312020. Accessed September 29, 2020.

[4] Sprout Pharmaceuticals. Label: flibanserin (ADDYI). October 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf. Accessed September 29, 2020.

[5] Food and Drug Administration. Warning letter to Sprout Pharmaceuticals, Inc. August 31, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-610569-08312020. Accessed October 1, 2020.