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
Search Results for: FDA petition
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
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
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
RxISK drug safety petition asks AbbVie and InterMune to stop blocking access to drug clinical trial data
Toronto, Ontario — September 13, 2013 – RxISK.org, the first free, independent website for researching and reporting prescription drug side effects, has launched a drug safety petition asking two pharmaceutical giants to stop blocking the European Medicines Agency (EMA) from releasing prescription drug clinical trial data. In 2010, the EMA began releasing patient-level data … [Read more...] about RxISK drug safety petition asks AbbVie and InterMune to stop blocking access to drug clinical trial data
AbbVie Petition: Drug Hazards are Not Trade Secrets
RxISK has started a petition on Change.org which will go to Richard Gonzalez CEO of AbbVie, and Daniel Welch CEO of InterMune, who are at present taking a legal action to block the European Medicines Agency's policy of open access to clinical trial data. The reason to petition is in this post Let's do the AbbVie again and the Petition is Here. Can you take 30 seconds to … [Read more...] about AbbVie Petition: Drug Hazards are Not Trade Secrets
Ordinary or Forgotten Women and Men
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
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
No Sex – We’re on Antidepressants
No Sex Please! (We’re on antidepressants). Based on 17th Century Kama Sutra and Ragamala paintings. © 2014 created by Billiam James. Post SSRI Sexual Dysfunction (PSSD) was the first born sexual dysfunction - before its Finasteride and Isotretinoin siblings - Finasteride and Consent - Isotretinoin and Consent. This video and post give you the background to PSSD which opens … [Read more...] about No Sex – We’re on Antidepressants
Isotretinoin and Consent
Isotretinoin and Safety outlines the efforts people disabled by Isotretinoin (Accutane, Claravis) and their families have been making for a decade to get medicines regulators in Britain (MHRA) as well as in Europe (EMA) and America (FDA) to make Isotretinoin use safer. Some of those who have been injured or who have lost children or partners think nothing short of banning … [Read more...] about Isotretinoin and Consent