Regulator moves to require SSRI antidepressants to carry product warnings on the risk of long-lasting sexual side effects

Drug companies will be required to include product warnings that antidepressant medication may cause long-lasting sexual dysfunction that could persist for years.

Escitalopram (Lexapro) is a selective serotonin reuptake inhibitor medication.

Drug companies will be required to include product warnings that antidepressant medication may cause long-lasting sexual dysfunction that could persist for years even after stopping the pills, as patients around the world report rare but severe ­adverse effects.

Australia’s medical regulator, the Therapeutic Goods Administration, has followed the European Medicines Agency in recognising that sexual dysfunction – which is a relatively common side effect of selective serotonin reuptake inhibitor medications – can in very rare cases persist for months or years.

All SSRI and similar serotonin norepinephrine reuptake inhibitor antidepressant medications sold in Australia now must carry the warning that the drugs “may cause symptoms of sexual dysfunction … there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of the SSRIs/SNRI.”

The reported incidence of post-SSRI sexual dysfunction is increasing around the world as rates of SSRI use reach astronomic proportions. One in seven Australians is now taking an antidepressant daily and there is now a mainstream push within psychiatry for deprescribing, particularly in the light of the drugs’ low rates of efficacy.

The TGA said it had received 89 reports describing sexual dysfunction with an SSRI or SNRI in its adverse event database. So far the authority has only received four reports of persistent sexual dysfunction after stopping the drugs, three in men and one in a woman. But it believes there are more people suffering the condition who haven’t ­reported it to the regulator amid hundreds of adverse reports recorded in Europe.

“Reported symptoms included difficulty reaching orgasm, weakened orgasms, erectile dysfunction and reduced penile sensation. The effects persisted for 12 months to 3½ years,” the TGA said in an update. “Persistent sexual dysfunction after treatment is stopped is thought to be rare. However, these symptoms are likely to be underreported and their prevalence is not currently known. Health professionals should be alert to this issue and consider if current or previous antidepressant use could be a factor in patients reporting sexual dysfunction … and report if they are suspicious of an association.”

Patients – tens of thousands around the world who identify with PSSD – have banded together in online groups, saying they believe the symptoms may be permanent.

Rosie Tilli from the PSSD Network said the TGA’s statement was a step in the right direction but still inadequate, and some drugs that may cause PSSD had not been included in the update. “Saying ‘sexual dysfunction may persist after stopping’ really waters down the severity of PSSD, which is permanent chemical castration for most people dealing with this,” she said. “People have missed out on the opportunity to find a partner, hold down relationships and start a family … we’ve had too many suicides because of this.”

The TGA’s move comes after a lawsuit was filed against the FDA in the US over its inaction on requiring the revision of product labels.

Several manufacturers of SSRIs had already moved in Australia to issue product warnings on a potential risk of persistent sexual dysfunction, but now all SSRI medications are subject to the requirement. The EMA acknowledged the risk some time ago.

Neurologist Julia Thompson. Picture: Supplied

It is notoriously difficult to establish scientifically whether PSSD symptoms are attributable to SSRIs. Australian consultant neurologist Julia Thompson welcomed the TGA’s statement but expressed some caution.

“There’s a signal now that there’s a reason to watch out for it, but it needs to be emphasised that the mechanisms are not understood,” Dr Thompson said.

“The exact reason why sexual dysfunction would linger is not fully understood. We are now trying to understand the pathogenesis. This is a difficult space when it comes to sexual function.

“I think it’s crucial to not state the drugs are the cause because people might have numbness from abuse or other things. The confounders are that those symptoms are also symptoms of depression and symptoms of chronic pain.”

Sydney obstetrician and gynaecologist Bronwyn Devine said the issue was a topic of active conversation among doctors. “I haven’t seen it in my practice but I have heard of SSRI-induced sexual dysfunction persisting even after cessation of these medications,” Dr Devine said.

“Many people have benefited from the use of these medications and they are very widely prescribed, but it’s important to recognise that some people are left with profound effects on their sexual responsiveness as a result of taking them.”