After a great deal of work, we are pleased to announce details of two new publications in the International Journal of Risk & Safety in Medicine. The pre-print versions are currently available.
The first is our new paper – Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase inhibitors and isotretinoin: 300 cases.
In 2014, we were the first group to publish details in the medical literature about persistent sexual dysfunction after using isotretinoin. Our new paper once again includes this problem. In fact, isotretinoin was the single most commonly reported drug in our study.
The journal would normally charge a fee of $35 USD to access the full paper unless you are a subscriber. In order to make it available to everyone, rather than hidden behind a paywall, it has cost around $1500 USD to buy open access rights. This did not come from the RxISK Prize fund. However, we would be grateful if everyone who reads the paper could consider donating $10 to the RxISK Prize as a gesture of support to those living with enduring sexual side effects.
In addition to the paper, we have also been putting together a petition to the Food and Drug Administration (FDA), requesting changes to SSRI and SNRI product labels to warn about post-SSRI sexual dysfunction (PSSD) and persistent genital arousal disorder (PGAD). The petition sets out in detail the nature of the problem, the history of the conditions, and what needs to be done about it.
As an extra measure we also sent it to the journal, and they accepted it for publication. This means the petition itself becomes a publication in a peer-reviewed journal and adds to the literature on PSSD and PGAD. The journal also very generously agreed to make it open access at no additional cost.
Citizen petition: Sexual side effects of SSRIs and SNRIs is available for download.
We consulted the FDA website for details on what to include, so if the wording looks stilted at some points, this stems from FDA requirements rather than our design.
In addition to FDA, we have also submitted the petition to the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), to request changes to European and UK drug labels.
We will be sending details of the new paper and petition to as many groups as possible, but we also need your help to promote them via social media, online forums, or any other networks that you have. You might want to print out copies and give them to your doctor. Another idea might be to print out several copies and mail them to every GP at your local medical practice – or maybe every urologist at your local hospital. If you have links to the media or other groups that might take an interest in these issues, please send them a copy.
We would like to thank the PFS Foundation for giving us the idea for the petition in the first place.
It has been nearly eight months since we launched the RxISK Prize, and we have seen some impressive efforts so far, both in terms of helping to spread the message and also raising funds.
Some people have contacted various medical groups to make them aware of the issues. One volunteer designed and printed a batch of business cards advertising the campaign, which she distributed within the community – on bulletin boards, in hospital waiting areas, in shop windows, etc. Another volunteer spent several days visiting a large number of pharmacies and doctors surgeries, providing them with information from the website. Someone else commissioned a piece of artwork which was auctioned, with all proceeds going to the Prize fund.
Donations have been received from 21 countries. The four videos that we made to support the campaign have received a total of over 6700 views.
Thank you to everyone who has contributed so far. Please keep your donations coming.