Some rare good news regarding one of our post-drug conditions.
After prompting by RxISK and many PSSD patients, the EMA’s pharmacovigilance committee has accepted persistent sexual side effects as a potential risk of SSRI and SNRI medications, as outlined in the recent RxISK newsletter:
The European Medicines Agency (EMA) has just concluded a review of Post SSRI Sexual Dysfunction (PSSD) and Persistent Genital Arousal Disorder (PGAD) after the discontinuation of SSRIs and SNRIs.
This follows a submission by RxISK of a petition in 2018 to EMA and FDA requesting changes to product labels to warn about PSSD and PGAD, and we have since been in touch with Health Canada. The petition covered the clinical literature on these conditions, was endorsed by a majority of the peer-reviewed authors of the medical literature on these conditions, and was accompanied by a RxISK publication on 300 cases.
One of the reasons that regulators may have been so slow to act in the case of PSSD and PGAD, despite significant numbers of reports to them, is because those reports are usually anonymous. This means there is no opportunity to follow them up and they can easily be dismissed as hearsay.
EMA indicated a willingness to consider individual named reports. After submission, therefore, we contacted more than 300 people who had reported PSSD or PGAD to RxISK, and within the tight time-frame permitted, managed to submit a total of 82 named reports, of which 32 contained supporting documentation from healthcare professionals.
On May 31, 2019, we received the following message from EMA:
Dear Professor Healy,
We are writing to you to inform you that the review by EMA’s safety committee PRAC into sexual dysfunction with SSRIs and SNRIs has now concluded. We would like to take this opportunity to thank you and the patients involved for your important contribution in supporting EMA in its role of supervising medicines’ safety in Europe. Patient reports such as the ones you submitted are essential to gain a better insight into a medicine’s safety profile and were a valuable contribution to this review.
On Thursday 16 May, PRAC concluded that sexual dysfunction, which is known to occur with treatment with SSRIs and SNRIs and usually resolves after treatment has stopped, can be long-lasting in some patients, even after treatment withdrawal. In addition to the patient reports provided, PRAC also assessed data from the published literature, clinical and non-clinical studies, as well as data gathered by the marketing authorisation holder in its safety databases and reports collected through the Eudravigilance database.
Based on this data it is currently not known how long these symptoms can persist, and the issue will continue to be closely monitored.
The outcome of the review was made public on EMA’s website on 11 June 2019:
You can view the document here.
We hope you find this information useful and we would like to take this
opportunity to thank you for your important contribution to public health.
European Medicines Agency
EMA’s public statement is now available at the above link. We are hoping for movement soon from FDA and Health Canada.
We would like to thank everyone who has been involved in this effort over the last year, including those who agreed to be signatories on the petition, everyone who completed a named report for EMA, everyone who attempted to get a supporting letter from a healthcare professional, and those healthcare professionals who agreed to write one, along with everyone who has contributed to the RxISK Prize or otherwise supported RxISK.
Your feedback, as always, is greatly appreciated.
David Healy, MD
This can be considered a huge victory brought forth by the efforts of active members of the PSSD community.
Meanwhile, the MHRA will not accept that Accutane’s sexual side-effects can remain indefinitely and the FDA’s Center for Drug Evaluation and Research still refuses to acknowledge the persistent nature of SSRI/SNRI sexual side-effects and flagrantly ignores Acctuane’s sexual side-effects.