FDA sued for failing to warn that sexual dysfunction caused by anti-depressants can persist even after withdrawal

Spot the odd one out: Cymbalta, Prozac, Paxil, Zoloft, Lexapro.

These are all commonly prescribed anti-depressants, but the odd one out is Prozac, as it's the only one listed here whose patient insert includes the information that the sexual dysfunction caused by the drug can persist even after treatment has ceased.

Now the FDA is being sued for its failure to warn the public of this devastating adverse effect. 

Six years and how many thousands of ruined lives?

“Now” is misleading, however, because the FDA was first petitioned on this issue (and asked to encourage doctors to issue warnings to their patients) back in 2018. Six years later and nothing has happened.

Prozac's patient insert only includes the warning, cautiously phrased, because its manufacturer, Eli Lilly, actually asked the FDA to add a few words, back in 2011. 

The FDA complied, but for some reason omitted to draw the logical conclusion that all drugs in the SSRI or SNRI class should have a similar warning attached, even though the dangers of these drugs have been known for decades (as a recent Frontline News article describes) and an estimated one in ten Americans over the age of 12 are taking them.

Why is the United States lagging behind the rest of the world?

Dr. David Healy and 21 other professionals submitted their original petition not only to the FDA, but also to the European Medicines Agency (EMA). The EMA responded in 2019 with a “New product information wording” which stipulated the language to be used in patient inserts, warning potential users of SSRI and SNRI drugs of “long-lasting sexual dysfunction where the symptoms have continued despite discontinuation” of the drugs.

In 2021, Health Canada followed suit, declaring that it would henceforth “work with manufacturers to update the product safety information” and that it was urging healthcare workers to “inform patients about the potential risk of long-lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.”

Earlier this year, the Australian health authorities also decided to require the amendment of patient inserts, “to reflect the risk of sexual dysfunction persisting in some patients after drug cessation.”

The FDA, however, has declined not only to take action but also to answer the petition, even though U.S. law requires it to respond within 180 days of receiving a petition. Patients who submitted case reports to the FDA have not been contacted by the agency.

FDA blocking informed consent

Now the Public Citizen organization has filed a lawsuit against the FDA, on behalf of Dr. Antonei Csoka, a researcher into PSSD (post-SSRI sexual dysfunction) and a scientific advisor for PSSD Network. The suit alleges that the FDA has behaved unlawfully in failing to act on the petition, and it asks the court to order the FDA to issue a decision.

“The FDA needs to act in a timely way to inform the public about the risks associated with use of these drugs,” said Michael Kirkpatrick, an attorney with Public Citizen and lead counsel. “The FDA’s failure to act exposes consumers to potentially life-long harm.”

Josef Witt-Doerring, a psychiatrist and former FDA medical reviewer, says he has spoken to dozens of patients with the condition who describe it as “torture.”

“It’s not just the sexual dysfunction that persists for years after stopping the drug, they also feel totally dissociated from life, almost as if they’re watching their life play out on a screen. They can’t feel anything,” explained Witt-Doerring.

Even though the risk of PSSD may be rare, the condition is severe enough to sway someone’s decision to take the drug. They might have mild depression and decide they’ll do talk therapy instead of taking the small risk of permanent sexual dysfunction. It’s important for people to have informed consent.

Not just anti-depressants

According to Dr. Healy, the widely prescribed drugs Accutane (which treats acne) and finasteride (taken to treat hair loss) can also cause PSSD. He stresses that the numbing effects (both physical and emotional) of the drugs can be felt as soon as 30 minutes after taking them, although many people will fail to recognize the symptoms. He also notes that PSSD can become worse after the drug is stopped, and that in some cases, an “opposite” condition can result where the person experiences persistent heightened feelings.

In 2021, Public Citizen sued the FDA for ignoring a petition (filed four years previously) calling for finasteride's withdrawal, after it was linked to depression, anxiety, and suicidal ideation. It took the FDA another nine months to respond, at which time it declined to withdraw finasteride (plus its generic forms) and instead required patient inserts to warn patients that there had been reports of “suicidal behavior” in people using the drug.

Brain Death

PSSD researchers frequently stress that the cognitive and particularly the emotional effects are described by sufferers as more debilitating than the physical effects. Dr. Healy's theory is that the underlying cause for all the various adverse events is a “loss of reactivity.”

This is why [SSRIs] are good with OCD [obsessive-compulsive disorder]. People aren't as reactive to [triggers] … they're not as bothered…

But it's the emotional numbness that people talk about, where their sensations aren't lighting the brain up as they should. There seems to be less imput to the brain; it's like the brain is dead, not processing things the way it should do.

Dr. Witt-Doerring concurs, adding that,

The people I talk to tell me things like, "I'll hug my mom or my dad or my child and I won't feel those same feelings that I used to feel. I'll listen to my favorite album from childhood that usually brings back nostalgia and memories and joy and it's just blunted.

Doctors don't know?

The original petition to the FDA demands not only that manufacturers alter the wording of patient inserts but also that they alert healthcare providers, via “Dear Doctor” letters, to the fact that the drugs they prescribe “pose a significant public health concern.” 

Commenting on the latest lawsuit, Maryanne Demasi, PhD said,

This should force the FDA to rule on whether it believes there is evidence that SSRIs can, in some cases, cause PSSD and update the label; it's important for sufferers that the condition is acknowledged, but may also be important for establishing whether people receive informed consent - and may even have legal consequences.

Multiple patient accounts report how their doctors knew nothing about PSSD. Even when doctors do have some knowledge of the symptoms, they can be dismissive of the suffering they cause, seeing them as minor tradeoffs for the greater benefit of depression relief. Others assume that loss of feeling is a result of the “underlying depression,” and that the answer could be a higher dose of the drug.

The answer provided by many sufferers has been to end it all, as Dr. Healy describes:

Many people who are left with PSSD conclude that if they're going to feel this way for the rest of their lives, what's the point in living?

Where is justice?

According to Lawsuit Information Center, Dr. Healy has been the “single most powerful voice” behind SSRI-based lawsuits over the past few decades.

He … was willing to take on the pharmaceutical industry 20 years ago … [which] led to the FDA conducting a review of clinical trial data and issuing a black box warning for all antidepressants, including SSRIs, for the risk of suicide … the strictest warning the FDA can require for prescription drugs…

This effectively ended litigation [against the SSRI manufacturers] because this was the warning Dr. Healy was saying was needed. But there are still SSRI malpractice lawsuits for failing to see the signs of SSRI-induced suicide.

Although thousands, and potentially millions, of people have been harmed, often irreversibly, by these drugs, legal experts are pessimistic regarding the chances of victims obtaining compensation, or justice.

Could this lead to a potential SSRI sexual dysfunction class action lawsuit? Probably not.  But this is something to keep an eye on.