Mid-Ulster Council lit up for July 29 Dr Gerald Dal Pan druginfo@fda.hhs.gov This letter was emailed to Dr Dal Pan on July 29, 2026 See Prescribed Harm Awareness and Stolen Lives for more on this. Dear Dr Dal Pan I listened with interest to your recent interview with Dr Celia Williams in a Q & A with FDA series, where you were asked which types of adverse event … [Read more...] about Ordinary or Forgotten Women and Men
Petitions
Adverse Events Need A Human Touch
One of the most dramatic moments in the annals of adverse events was when in 2008 Audrey Bahrick, a psychologist linked to the U of Iowa, contacted her senator, Senator Chuck Grassley, telling him about Post SSRI Sexual Dysfunction (PSSD) and asking him to alert FDA to the problem in the hope that something could be done to ensure not too many people were affected. He did as … [Read more...] about Adverse Events Need A Human Touch
FDA Responds to Isotretinoin Petiton
Recap Shortly after RxISK was launched in 2012, we began receiving reports and messages from people complaining of persistent sexual dysfunction after stopping isotretinoin, a medication used in the treatment of acne. This was interesting because it seemed to have common elements with post-SSRI sexual dysfunction (PSSD) and post-finasteride syndrome (PFS). As a result of … [Read more...] about FDA Responds to Isotretinoin Petiton
FDA Sued for Failing to Act on RxISK’s Petition
In February 2018, we began work on a petition requesting warnings about post-SSRI sexual dysfunction (PSSD) and persistent genital arousal disorder (PGAD) to be added to SSRI and SNRI antidepressants. The academic literature on these conditions had been steadily increasing, and our latest case series on persistent sexual dysfunctions had just been accepted for publication - … [Read more...] about FDA Sued for Failing to Act on RxISK’s Petition
Health Canada warns about Persistent Sexual Dysfunction after SSRIs & SNRIs
Health Canada has just concluded its review of persistent sexual dysfunction after stopping SSRIs and SNRIs. Let’s look at some of the background. January 2019 On 25 January 2019, we were contacted by the Marketed Pharmaceuticals and Medical Devices Bureau at Health Canada. They had become aware of our 2018 paper, “Enduring sexual dysfunction after treatment with … [Read more...] about Health Canada warns about Persistent Sexual Dysfunction after SSRIs & SNRIs
EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs
The European Medicines Agency has just concluded a review into sexual dysfunction after the discontinuation of SSRIs and SNRIs. Before we discuss their findings, it's worth looking back over the events of the past year. RxISK petition In 2018, we put together a petition requesting changes to SSRI and SNRI product labels to warn about post-SSRI sexual dysfunction (PSSD) and … [Read more...] about EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs
Post-Retinoid Sexual Dysfunction (PRSD) Petition
There are long-standing reports of sexual dysfunction linked to the use of isotretinoin, a retinoid drug used in the treatment of acne. FDA and MHRA received the first reports of sexual dysfunction involving isotretinoin in 1983 and 1985 respectively, and according to a publication in The Lancet, Roche had received 150 reports of problems affecting the male reproductive system … [Read more...] about Post-Retinoid Sexual Dysfunction (PRSD) Petition
Enduring Sexual Dysfunction: 300 Cases
New publications 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. [Now updated with printed versions - June 11, 2018.] The first is our new paper – Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase … [Read more...] about Enduring Sexual Dysfunction: 300 Cases
AbbVie Petition Signers with a Story to Tell
This selection of quotes abbreviates in many cases what was written. The contributions come from all the continents who have signed. On statins (10) ES: Memory loss, couldn't walk very far. came off statins and back pain went within a few days. DG: My body has been damaged by the statin drug simvastatin. If I had know about all its potential side effects, I would have … [Read more...] about AbbVie Petition Signers with a Story to Tell
Extreme Petitioning
Thank you to everyone who signed RxISK's Drug Safety Petition asking pharmaceutical giants AbbVie and Intermune to stop blocking the European Medicines Agency (EMA) from releasing prescription drug clinical trial data. Only one person signed the United States Declaration of Independence – but this made a difference. The RxISK Drug Safety Petition now has 6000+ signatures … [Read more...] about Extreme Petitioning