Accutane: Your face or your future (part one)
Many people have heard of Thalidomide babies, but how many people have heard about Accutane babies?
And how many people have heard about all the babies that will never be born because of Accutane, a drug that can cause not only infertility, but also the inability to engage in reproductive behavior?
Chemotherapy for your skin
Isotretinoin, the active substance in Accutane and other similar drugs, was first tested in the 1960s, for treating not acne but certain types of skin cancer. In 1971, researchers at Roche pharmaceutical laboratories in Switzerland realized that the drug cleared people’s skin in a quite exceptional manner — but they also found that it was a teratogen, a drug that causes birth defects, far worse than thalidomide. This being just a few years after the thalidomide scandal, they dropped further research into isotretinoin.
Four years passed, and American researchers at the government NIH (National Institutes of Health) also came across isotretinoin. They too were aware of the associated risks, but decided that if effective measures were taken to prevent pregnant women from taking it, the benefits outweighed the risks.
So it was that Roche, learning of these developments, resumed its research. In 1981, isotretinoin gained FDA approval.
And so begins the spin
When submitting its clinical trial results to the FDA in order to receive approval, Roche proposed that a class C label should be applied to Accutane, which signifies that “studies in animals have revealed adverse effects of the fetus and there are no controlled studies in women ... Drugs should be given only if the potential benefit justifies the potential risk to the fetus.”
Roche justified this request based on the fact that no human babies had been exposed to the drug during its trials. However, one trial volunteer did accidentally become pregnant and Roche strongly advised her to abort the baby, which she did.
The FDA, however, insisted on an X category which indicates that the risk to the fetus outweighs any potential benefit from using the drug during pregnancy.
Dear Doctor, why aren’t you listening?
Over the ensuing years, multiple attempts were made to have the drug pulled from the market due to its dangers, or to have the FDA impose stricter controls on it. In Europe, far more cautious governments and healthcare workers ensured that access was limited and usage monitored. In the United States, the FDA — but not only the FDA — resisted stricter controls.
Roche itself, anxious to avoid lawsuits, offered to pay for contraceptive counseling for anyone using the drug. Doctors were addressed using “Dear Doctor” letters in which they were educated about Accutane’s risks and told that women of childbearing age should be on at least two forms of effective contraception while taking the drug. But studies conducted periodically showed that regardless of all the efforts, women were still becoming pregnant while using Accutane, and babies with extremely severe birth defects were being born.
In 2000, the FDA revisited the issue and reviewed evidence from Roche showing that almost 2,000 women had taken Accutane while pregnant, despite the measures that had been implemented to prevent this from happening. Among these women, a third had not used contraception at all. 14 percent had been pregnant without realizing when asking their doctor for a prescription, and their doctors had failed to require a negative pregnancy test before prescribing, as the recommendations stipulated.
Doctor: Why should I listen to you?
It was clear that relying on doctors to keep unborn children safe from the effects of Accutane was not working. Nonetheless, Dr. Barbara Reed, a member of the Board of the American Academy of Dermatology who spoke during the FDA consultations, chose to highlight the importance of keeping relatively free access to Accutane, saying that,
There is no single disease which causes more psychic trauma, more maladjustment between parents and children, more general insecurity and feelings of inferiority and greater sums of psychic suffering than does acne.
Another dermatologist complained that stricter controls represented unwarranted government intrusion into the medical profession:
As an individual practitioner, it was my decision that this patient be treated with Accutane, and it should remain my decision and not that of the manufacturer or pharmacist, or anyone else ... I am convinced that education ... is the way to accomplish this.
Hundreds of new Accutane Babies every year
Six years passed before the FDA took further action. This time, it came in the form of iPLEDGE, a registry program for anyone seeking a prescription for Accutane. One of its requirements is that pharmacists may not dispense the drug unless the customer has a negative pregnancy test result from within the preceding 7 days.
Potential users must also sign an informed consent form which includes 13 sections on the dangers of the drug for a fetus, the importance of using contraception, and confirmation that the doctor has explained the drug’s risks and benefits to the patient. The doctor must also sign the form which is then inserted into the patient’s medical records.
That was 2006. A few years ago, research using the FDA’s public database of reports of drug adverse events revealed that between 1997 and 2017, there had been almost 7,000 Accutane-exposed pregnancies. In the first year of iPLEDGE, there were 768 Accutane pregnancies; in every year since, there have been between 200 and 300.
If all these babies are aborted, can we pretend they never existed?
In 2014, Roche pulled Accutane from the market due to indications that it was linked to inflammatory bowel disease; at least one study showed double the likelihood of developing this syndrome in Accutane users. But there are plenty of other forms of isotretinoin on the market, and one doesn’t even need a doctor’s prescription, given the ease of buying the pills on the internet.
Toward the end of 2023, a study came out confirming the dangers of Accutane exposure for a fetus. Many mothers (around two-thirds, in this study) abort such babies while others continue with the pregnancy for a variety of reasons. Among those babies allowed to be born, almost 30 percent had congenital abnormalities compared with 1.4 percent in the control group (no Accutane exposure, ever). 12 percent of these “Accutane babies” were born prematurely. 13 percent of the pregnancies ended in miscarriage (compared to 4 percent in the control group).
But there was a third group examined in this study, comprising mothers who had taken Accutane only prior to becoming pregnant.
After using some form of statistical analysis, the researchers succeeded in concluding that the number of damaged babies in the "prior exposure" group was insignificant:
While evaluating congenital anomalies, we detected statistically significant differences between isotretinoin exposure vs control, but we did not detect any statistical differences between isotretinoin exposure before the pregnancy and controls.
Safe a month later? Where’s the evidence?
While women planning to start a family might welcome a glance at the graph above and interpret it somewhat differently from the researchers, official advice to such women coming off Accutane recommends waiting a month before trying to become pregnant and fails to warn of any long-term consequences of use, as the questions and answers in this NIH “Mother to Baby Fact Sheet: Isotretinoin” show:
I am taking isotretinoin, but I would like to stop taking it before pregnancy. How long does it stay in my body?
[Answer:] People eliminate medication at different rates. In healthy adults, it takes up to 6 days, on average, for most of the isotretinoin to be gone from the body. However, it is recommended that a person wait one month after stopping isotretinoin before trying to get pregnant.
What about Accutane Non-Babies — that is, infertility?
The same Fact Sheet belittles the notion that use of Accutane could impact fertility at all:
I take isotretinoin. Can it make it harder for me to get pregnant?
[Answer:] People who are trying to get pregnant should not be taking isotretinoin. There have been reports of changes in the menstrual cycle (periods) in some people taking isotretinoin. There are no reports of problems getting pregnant while taking isotretinoin.
In fact, there are many anecdotal reports from women who find themselves unable to become pregnant after using Accutane. They, and their doctors, have no idea why this should happen. And no one has a cure for them.
According to one renowned naturopath,
I can’t help these women. They come to me crying that they can’t get pregnant. I’ve tried many things, but nothing seems to work. By now, once I find out that they used Accutane, I virtually despair of their chances. Don’t take this drug!
Studies have not been done... Why not?
On the question of male fertility, the NIH is more cautious in its language:
If a male takes isotretinoin, could it affect fertility or increase the chance of birth defects?
[Answer:] There have been a few reports of erectile dysfunction (trouble with getting and keeping an erection) and ejaculatory failure (no seminal fluid comes out of the penis) in males taking isotretinoin. This can affect fertility (ability to get partner pregnant). Studies have not been done in males to see if isotretinoin could increase the chance of birth defects.
This statement is untrue in many respects.
There have been a few reports...
There have been many reports, certainly in the thousands, though not always to the FDA or other authorities, related to sexual dysfunction related to use of Accutane.
This can affect fertility...
In such cases, fertility is a far-off dream. Males who use or have used Accutane cannot even engage in reproductive behavior, let alone imagine fertilizing their partner.
If a male takes isotretinoin...
The problems caused by taking any drug containing this substance are not restricted to the period of treatment. Sexual dysfunction can persist for months, years, and even decades afterward.
To be continued...
The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial or legal advice. Always consult a physician, lawyer or other qualified professional regarding any questions you may have about a medical condition, health objectives or legal or financial issues. If you are struggling with suicidal thoughts, you can call a qualified free mental health helpline or seek help from a qualified therapist.
