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FDA Negligence and Big Pharma The 'Criminal' Truth About Antidepressants and Other Drugs
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The FDA and Big Pharma are under scrutiny for poisoning patients through lax testing and regulations, resulting in lasting harm. Pharmaceutical companies, thanks to their powerful lobbying, essentially govern themselves, leading to a never-ending series of hard lessons learned by patients who suffer from the long-term, ill effects of medications they were assured were safe.
Photo credit: Dim Hou
Highlights
5/23/2024 (4 months ago)
Published in Health
Keywords: FDA, Big Pharma, antidepressants, SSRIs, Prozac, Zoloft, sexual dysfunction, PSSD, fertility, patient harm
Currently, the FDA is being sued for allegedly ignoring evidence that certain antidepressants permanently damage patients' sexual health, even years after they stop taking the medication. Drugs like Prozac and Zoloft only began carrying labels warning of sexual side effects--such as erectile dysfunction, low libido, vaginal dryness, and trouble orgasming--after patients started complaining to their doctors in the 1980s and 1990s.
Despite these warnings, thousands of former patients now report being left completely asexual, numb below the waist, and unable to enjoy sex or sustain romantic relationships. Some have even experienced genital shrinkage. The FDA is now being sued by scientists who claim the agency has ignored their petition since 2018 to include a warning about permanent sexual side effects. They are demanding the FDA warn doctors and patients about these long-term risks.
The condition in question is Post-SSRI Sexual Dysfunction (PSSD), which can cause genital numbness, complete loss of libido, erectile dysfunction, and other sexual function issues that persist for years after discontinuing the medication. As fertility rates in the US drop, more Americans are being prescribed SSRIs, the most common type of antidepressant, which can also lower sperm quality in men.
An estimated one in ten Americans aged 12 and up takes an antidepressant. The lawsuit, filed by Dr. Antonei B. Csoka, a molecular biologist at Howard University, highlights the FDA's failure to follow its own protocol, which requires a response to citizens' petitions within 180 days. Despite promising to review the science in 2018, the FDA has not added the proposed warning label. In contrast, regulatory agencies in Europe and Canada have already done so.
While the exact number of people affected by PSSD is unknown, more than half of all antidepressant users report some degree of sexual dysfunction while taking these medications. A 2018 review of scientific literature found that 5-15% of people on antidepressants developed sexual side effects like erectile dysfunction and lack of sex drive after taking SSRIs and SNRIs.
Dr. Csoka, an advisor to the PSSD Network, which advocates for patients to share their stories and raise awareness, has been researching sexual dysfunction linked to antidepressants since the early 2000s. He was among the first to suggest that these medications, by increasing serotonin levels in the brain, cause DNA modifications that affect the genes regulating sexual function.
One male patient, prescribed various antidepressants as a teenager to cope with his father's death, now suffers from extreme genital shrinkage, severe erectile dysfunction, and premature ejaculation at 25, years after stopping the meds. Another woman, off her antidepressant for three years, says her clitoris feels like a "dead lump." A third patient who took Lexapro for three months reports feeling asexual, unable to feel attraction or pleasure, and experiencing general emotional blunting.
Dr. Csoka's lawsuit seeks to compel the FDA to issue a decision on the petition. The surge in antidepressant prescriptions over the past two decades, with nearly one in five adults taking them in 2020, coincides with the country's declining fertility rates. A 2022 meta-analysis found that SSRIs significantly impair sperm quality, contributing to the overall fertility decline in the US, where the average number of children per woman has fallen from 2.3 in 1970 to 1.7 in 2020.
The FDA's negligence and Big Pharma's self-regulation highlight a systemic failure that leaves countless individuals to suffer the consequences. It is a stark reminder of the urgent need for rigorous oversight and transparent communication in the pharmaceutical industry. The health and well-being of the public depend on it.
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