The FDA is being sued for allegedly ignoring evidence that antidepressants permanently ruin patients’ sex lives, even years after stopping them.
Selective serotonin reuptake inhibitor (SSRI) drugs, such as Prozac and Zoloft, began to carry a label warning their users that they could cause erectile dysfunction, low libido, vaginal dryness, and problems reaching orgasm only after patients They began complaining about sexual side effects to their doctors in the 1980s and 1990s.
But thousands of former patients say they have been left completely asexual, numb below the waist and unable to enjoy sex or maintain romantic relationships. Some patients have even experienced a reduction in their genitals.
The FDA is now being sued by a team of scientists who say the agency has ignored Your request calling for a warning about permanent sexual side effects since 2018 and is asking the agency to warn doctors and patients about the long-term risks.
The condition mentioned in the lawsuit is post-SSRI sexual dysfunction (PSSD), which can cause genital numbness, complete loss of libido, erectile dysfunction, and other sexual function problems for years after stopping. the drugs.
As the fertility rate in the US gradually declines, more and more Americans are being prescribed SSRIs, the most common type of antidepressant. These medications can cause lower sperm quality in men
An estimated one in 10 Americans ages 12 and older takes an antidepressant.
The lawsuit was filed by Dr. Antonei B. Csoka, a molecular biologist at Howard University,
The specific condition Dr. Csoka refers to in his complaint is post-SSRI sexual dysfunction (PSSD), which can also cause genital numbness, premature ejaculation, and emotional dullness.
The agency said in 2018 that it would further review the science and contact him, but never did.
The FDA’s alleged lack of follow-up contradicted its own protocol, which says that citizen requests require a response within 180 days.
While the FDA has not added the proposed warning label, regulatory agencies in Europe and Canada have already done so.
Scientists don’t know for sure how many people are affected by PSSD, although more than half of all antidepressant users have reported some degree of sexual dysfunction while taking them.
A 2018 review of the scientific literature on PSSD found that about five to 15 percent of people taking antidepressants developed sexual side effects, such as erectile dysfunction and lack of sexual desire, after taking SSRIs and SNRIs.
Dr. Csoka is an advisor to PSSD Network, an advocacy organization that encourages patients to tell their stories to raise awareness and hopefully find a cure for long-term sexual dysfunction.
Commonly prescribed antidepressants include SSRIs, which increase levels of the mood-regulating serotonin in the brain, and SNRIs, which increase levels of both serotonin and another neurotransmitter, norepinephrine, both of which currently include labeling on packages. that warn of sexual side effects.
Drug manufacturers must warn patients and prescribers that their medications could cause low libido and a decreased ability to have an orgasm, but they are not required to disclose that these effects could be permanent.
Dr. Csoka saying: “Without adequate warnings about the risk of potentially permanent damage to sexual function, patients and health care professionals cannot weigh the benefits of using the medications against the potential harms.”
Patients sharing their stories through the PSSD Network have described a variety of disorders ranging from erectile dysfunction, genital shrinkage and numbness to a lack of sense of attraction to others and an inability to feel pleasure.
One patient had been prescribed several antidepressants at different times when he was 16 years old to cope with the death of his father and was able to stop taking them in his 20s.
Now, at 25 and without taking medication, he has ‘Extreme genital shrinkage and discomfort, I have a neurological dysfunction of the smooth muscle of my penis that causes hypercontraction or a persistent arousal disorder.
“I have constant overactive bladder, urination, I have severe erectile dysfunction and premature ejaculation… I never had any of this before taking the medications.”
And he added: ‘I have seen a urologist specialized in sexual health who recognizes the existence of PSSD; ‘He did an ultrasound on my private parts and told me I have fibrosis, and he said it’s very common to see that in men who take antidepressants for a while.’
Meanwhile, one patient stopped taking her antidepressant three years ago, but said her now sexuality is gone.
She said: “My clitoris feels like a dead lump.”
And a third patient who had been taking Lexapro for about three months said that “asexual now Of medicine.’
He said: ‘I used to be able to look at people I was attracted to and feel something, but now I don’t feel anything, it’s like staring at a wall. Basically, taking away almost all the positive emotions, they went from 100 to maybe less than one, that’s how strong it is.’
He added that the hardest part of the general emotional dullness caused by the medications: ‘When you hug the people you love, your mother, your father, your nephew, you don’t feel anything… You can’t form any emotional bond at all. ‘
Dr. Csoka has been researching antidepressant-related sexual dysfunction since the early 2000s and was one of the first to postulate that the medications, as a side effect of increasing serotonin levels in the brain, caused changes in the DNA that affect the activity of genes that regulate sexual function.
He told the guardian: ‘Several scientists, including myself, have published studies showing that an SSRI can change epigenetics and human cells.
“If that happens, those cells or tissues may not immediately return to the way they were once treatment stops.” It’s like they left a mark there. However, it is still not known precisely what these epigenetic changes are. So what we have to do is narrow it down: what’s going on?
Your demand archived in the United States District Court for the District of Columbia seeks to compel the FDA to issue a decision on the petition.
The United States has seen fertility rates fall to historic lows in recent years, attributable to a large population of women who want to focus on their careers before starting a family, as well as sedentary lifestyles that decrease fertility.
But the explosion in antidepressant prescriptions over the past two decades has also been blamed for the country’s baby crisis.
A 2022 meta-analysis in Frontiers in pharmacology found that SSRIs have “a statistically significant impairment in semen quality, such as sperm concentration, sperm morphology, and sperm motility,” the researchers wrote. However, semen volume was not affected.
Since they became widespread in the 1980s, prescriptions for mood-enhancing drugs have skyrocketed, with a record high of nearly one in five adults taking them in 2020, compared to about one in 50 in early 2020. century.
This could contribute to the overall fertility rate in the United States, which has been falling steadily for decades.
In the United States, women had an average of just 1.7 children, according to the United Nations’ World Population Prospects, in 2020. In 1970, that rate was 2.3.
The global fertility rate (the average number of children born per woman) was 2.3 in 2020, compared to 4.7 in 1970. This is a staggering 51 percent drop.