Clinicians Urge U.S. to Adopt Antidepressant Warning on Persistent Sexual Dysfunction
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Editorial Dept.
The U.S. Food and Drug Administration (FDA) has recently debated the need to release a boxed warning for the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, citing the risk of autism and cognitive issues to the developing fetus. Many medical experts, however, noted that such harm has insufficient evidence.
While the need for the regulation remains under debate, doctors from Flow Neuroscience, the company behind a brain-stimulation device for depression, say the FDA is overlooking an immediate and well-documented risk to adults: persistent sexual dysfunction, which continues after the medication is stopped, and sometimes indefinitely.
Up to 80% of people taking antidepressants experience sexual dysfunction, which includes loss of libido, genital anesthesia, and anorgasmia. In some cases, these symptoms persist long after the medication is stopped.
Research shows that irreversible sexual dysfunction affects 1 in 216 people taking SSRIs. Various studies, case reports, and drug-safety reviews have documented the condition.
“We see patients unable to feel any kind of sexual sensations for years, sometimes decades after they stopped taking antidepressants. Most of them weren’t warned that the drug could cause long-term damage,” says Dr. Hannah Nearney, clinical psychiatrist and UK Medical Director at Flow Neuroscience.
Dr. Nearney adds that persistent sexual dysfunction is most often irreversible, as there’s currently no universally effective and definitive treatment for it.
“When a drug can leave sexual function impaired after treatment ends, it should be called a serious, potentially life-long physical injury, not a side-effect,” adds Dr. Nearney. “Patients have the right to know about such risk, and to choose whether they are willing to accept it.”
In the U.S., SSRIs as a drug class carry no warning about the risk of persistent sexual dysfunction – not on the packaging, in patient leaflets, or in prescriber guidelines.
By contrast, regulators in Europe, Australia, and Canada require all SSRI labels to carry such a warning in patient information and instructions for clinicians.
The only drug that has such a warning in the U.S. is Prozac (fluoxetine). The warning appears in the patient leaflet and was added by the manufacturer in response to findings from its own trials.
“Class-wide warnings about persistent sexual dysfunction are the only way to ensure consistent disclosure across the medical community,” says Dr. Nearney. “Warnings make it standard practice for doctors to discuss risks with patients and consider alternative treatments.”
On the other hand, clinicians already treat mental health conditions with non-drug therapies that don’t cause sexual side effects. For example, in the UK, the Flow brain stimulation device is used and prescribed in NHS clinics to treat depression.
“Brain stimulation is one of the safer alternatives. Such treatments don’t disrupt the natural balance of neurotransmitters that supports healthy sexual arousal and response. Nor do they alter testosterone or estrogen, hormones directly influencing libido,” explains Dr. Nearney.
Neurostimulation therapies utilize gentle electrical currents or magnetic fields to regulate specific brain circuits associated with mood regulation, stress, and anxiety.
“Patients in the U.S. should get the same disclosure about persistent sexual dysfunction as seen elsewhere. With a class-wide SSRI warning, every person would have a fair chance to weigh alternatives before starting treatment,” says Dr. Nearney. “Medication isn’t the only way – emerging non-drug therapies offer evidence-based options with minimal health risks.”
About Flow Neuroscience
Flow Neuroscience is a healthcare company that focuses on tDCS therapies and devices. In 2016, it was co-founded in Sweden by Daniel Mansson, a clinical psychologist, and Erik Rehn, an engineer. Erin Lee joined as CEO in 2022, having previously worked at Google, Uber and Babylon, and the company is now based in the UK. Flow is the only at-home medical tDCS device with clinically proven effectiveness in treating depression. It is not only used by the National Health Service (NHS), but also available and has passed regulations in Europe, Norway, Switzerland, and Hong Kong.
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