This post has two parts – updated labeling requirements from the FDA last month and a new marketing campaign from Sprout Phamraceuticals (thanks to redbeardace for flagging it!)
I’m going to address the FDA changes first because I’ve had more time to read up on it, but I think the latter is going to be a bigger concern for ace activists moving forward.
Part 1: FDA Recommends Labeling Changes for Addyi
I missed this earlier, but apparently the FDA released updated labeling requirements for Addyi/Flibanserin last month:
I’ve only had a chance to skim it for now, but it looks like they are downgrading the original warning (which stated that women should not drink alcohol at all while using the drug) to a statement that women should avoid alcohol within a few hours of taking the pill, but may not need to avoid it entirely:
Based on the results of postmarketing studies, the FDA has determined that changes must be made to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely. Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.
The FDA is ordering a safety labeling change requiring Sprout to make these changes because the agency was not able to reach an agreement with the company, which was continuing to request removal of the boxed warning and contraindication about alcohol completely from the product labeling. The FDA determined, based on a careful review of available data, that removing this important safety information was not acceptable for the protection of public health.
These changes were based on the results of two additional post-market studies of Addyi/Flibanserin, whcih sprout had requested, as well as additional lobbying from Sprout Pharmaceuticals (which sells Addyi) which wanted to remove alcohol warnings entirely. The FDA’s April 11 post stated:
In the FDA-required postmarketing trial in women who took Addyi and drank alcohol at the same time, there were missing or delayed measurements for blood pressure from when the women were first laying down to when they stood up that are critical in determining the risk of hypotension and syncope when taking Addyi and alcohol together. The FDA’s specific concerns with the trial included:
- While there were no reports of syncope or hypotension needing intervention amongst women in the trial, the safety precautions built into this trial did not allow for an adequate assessment of this risk. For example, women with low blood pressure while lying down or with symptoms that could be related to low blood pressure (such as dizziness) were not permitted to stand up to have blood pressure measurements taken or had to have repeated blood pressure measurements while lying down until they were high enough for the women to safely stand up. As a result, the data collected had missing or delayed blood pressure measurements from these women while standing.
- Many more women had missing or delayed blood pressure measurements when they took Addyi and alcohol together compared to when they received alcohol alone or Addyi alone.
- The amount of missing blood pressure measurements peaked around the time when Addyi’s blood levels were highest in those taking Addyi with alcohol.
The pattern of the missing or delayed measurements provides further evidence of an interaction between Addyi and alcohol that can increase the risk of hypotension and syncope. Given these results, the FDA has determined that the boxed warning and contraindication continue to be warranted. Women at home will not have the safety measures that were included in this trial or necessarily have access to immediate assistance if they were to experience severe hypotension or syncope, which can lead to serious outcomes including falls, accidents and bodily harm.
Part 2: New marketing campaign from Sprout Pharmaceuticals
Addyi has launched a new “Right to Desire” campaign website [content warning: I strongly recommend not taking any medical advice or trusting any claims from this new site.].
This CNN Health article discusses the campaign in more depth and has some initial criticism.
It features a quiz that you can take, which I’m especially worried about based on what they did the last time they decided to have a quiz as part of the very misleading “Find My Spark” campaign.
I’m still looking into the new campaign and will probably need to make another post to actually evaluate it, but I’m like 3 questions into the quiz and we’re already off to a pretty bad start – despite the first questions at least allowing me to state that I have no sex drive* and no problem with that, Addyi doesn’t want to let me think of it as anything except a problem:
It also still uses “HSDD” as their label for the low desire that they are trying to treat, despite the fact that as of the DSM 5 (released in ~2013), low desire is categorized as [M]HSDD only in men, and low desire in women is referred to as FSIAD or “Female Sexual Interest/Arousal Disorder”. Addyi is only marketed to and approved for women. (props to David Jay for pointing that out to me).
Also, I’m still mad that they decided to use purple for this. Adding insult to injury much?
*Technically I do personally consider myself to have a sex drive / libido, just not towards other people, but I don’t think that’s what Addyi’s asking about and I also wanted to see how it treats the many aces who really don’t have anything along those lines.