Accutane Users Are “Terrified” In The Wake Of Roe v. Wade Reversal

As we live through the scary and uncertain time following the Roe v. Wade reversal, women across the country are concerned about how the ruling might affect their access to abortion, birth control, and, now, skin-care medication like Accutane.

Accutane, also referred to as isotretinoin (Accutane is the brand name for the drug isotretinoin), was first introduced in 1982 — so, almost a decade after Roe v. Wade was passed. It's an oral retinoid prescription drug that, for millions of people, has cured severe, debilitating acne that has not responded to other medications. Among other drawbacks, like chapped lips and muscle soreness, Accutane carries a notorious black-box warning — taking it while pregnant can cause a miscarriage or severe birth defects.

Accutane is "incompatible with pregnancy," prescribing dermatologist Michele Farber, MD, FAAD underlines. Yet, many users are expressing concerns about a troubling potential reality: accidentally getting pregnant while on Accutane and not having access to abortion care. Following the recent Supreme Court ruling, Accutane users active in the subReddit community /r/Accutane have been questioning their protections — How can [doctors] ethically prescribe teratogenic black-box warning drugs in states where women aren't protected?; as well as their access to skin-care medication — Will Accutane get banned?

While some of the specifics remain unsettled, one thing is certain: Accutane will be prescribed at an increased risk as access to abortion continues to dwindle. One Redditor replied to the thread, sharing, "I’m sick to my stomach at the thought of getting pregnant during my course and not being able to get an abortion." Another out of Texas echoed, "I'm terrified of having sex now that Roe v. Wade has been overturned."

There are myriad reasons the Roe v. Wade reversal will be dangerous and affect people's health in negative ways. And yes, this also includes Accutane users. Here's what you need to know.

Generally, yes, Accutane is safe; however, it can be dangerous if the person taking it were to become pregnant or is pregnant. According to the FDA's 1979 Pregnancy-Risk Assessment, Accutane is a Category X drug (the highest risk classification) as human and animal studies have demonstrated it to cause fetal abnormalities in the case of pregnancy. Which is to say, it has always, and will continue to be prescribed judiciously.

According to the FDA, a patient on Accutane must prevent pregnancy before, during, and one month after stopping isotretinoin. There are a lot of safeguards in place, which we'll get to. Still, it's important to acknowledge that for so many people, getting an Accutane prescription is the last-ditch effort to clear their skin. "If someone is choosing Accutane, most often, they've exhausted other options," says Dr. Farber. "In choosing to do Accutane, it's not a first try, it's because they're not responding to other [medications] and they need it." 

Even in this Post-Roe world, whether you live in a state with an abortion ban or not, candidates for Accutane — people who have tried other acne treatments with little or no success, and those who have cystic acne that leaves scars — have to go through a standardized process called the iPledge Risk Evaluation and Mitigation Strategy (REMS), which is "intended to prevent fetal exposure to isotretinoin and inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe use conditions," explains a Chanapa Tantibanchachai, M.S., a Press Officer from the FDA.

To begin a course of Accutane, which typically runs an average of six to nine months, a doctor must first verify that the person is not pregnant. "You have to take two negative pregnancy tests thirty days apart, just to even get your first prescription," Dr. Farber says, "and you have to have a negative pregnancy test each month to renew your prescription."

Following the two confirmed negative pregnancy tests, a patient has to go through counseling on contraception. Accutane users have to use two effective forms of birth control together all the time — or practice abstinence — to prevent pregnancy while on Accutane. For a sexually-active person, two forms of birth control might be having an IUD and always using condoms. The doctor and patient agree on the patient's contraception plan and input the two forms in the online iPledge portal separately. The birth control plans have to match up exactly — to verify counsel and a plan for effective contraception — before the Accutane medication can be ordered.

Once the prescription has been administered, the patient will have to visit their dermatologist at least once a month for blood work to monitor liver enzymes and cholesterol, and will take pregnancy tests to ensure that they remain not pregnant. At home, the patient will take one pill twice a day. On the pill box, there's a silhouette of a pregnant person with a large 'X' through the center, a daily reminder of the importance of pregnancy prevention.

With these protections in place, Dr. Farber says, "If you're careful and taking your two forms of birth control, pregnancy on Accutane is very rare because there is a system in place. With that said, it's not impossible."

This is worst-case scenario. Given that Accutane is a Category X drug, if accidental pregnancy occurs, most physicians would recommend that the pregnancy be terminated due to the risk to the fetus. "There are known defects," Dr. Farber explains. "Accutane is teratogenic, so a fetus could have heart defects, craniofacial defects — there are a lot of issues if someone's on it and they become pregnant." 

According to a 2007 research article following pregnant women exposed to isotretinoin published in Jama Dermatology, a monthly peer-reviewed medical journal published by the American Medical Association, in the years between 1982 and 2007, over 2,000 U.S. pregnancies were affected by fetal exposure to isotretinoin, most resulting in spontaneous or elective abortions. However, for those cases which abortion was not elected, the study found the main fetal abnormalities to be craniofacial, cardiac, central nervous system, and thymic — that could look like a cleft palate or a lifelong cognitive challenge. Additionally, the article asserted, "there is no safe level of exposure: any exposure can cause malformation." As for the risk to the pregnant person who carries an exposed fetus to term, the article found that they would "require careful support and monitoring."

For the past 40 years that Accutane has been prescribed, abortion has always been an option in the case iPledge safeguards fail. Now, some practitioners have questions about what could happen if they have to see a pregnancy through.

"With monthly pregnancy tests, it's highly likely that someone would find out about pregnancy very early," Dr. Farber admits. "While this is incredibly helpful, there's no safe level of exposure to Accutane and it is possible to have birth defects even with short exposures." She practices in Pennsylvania, a state where abortion is still legal, though there are notable restrictions. If there was a case where a patient had an accidental pregnancy while on Accutane — which she tells me has never happened in her decade-long career — they would be able to terminate. "While it is possible that a [fetus] may be healthy at birth, there is a definite risk, no matter how briefly one is taking Accutane during pregnancy. I'd also be concerned about later developmental issues[...]even in the absence of obvious birth defects. While there are reports of people who have chosen to continue pregnancies on Accutane, it's so important that they have the choice and can make an informed decision based on facts."

So, we know the chance of pregnancy is statistically unlikely, given the safeguards and iPledge. Still, I asked Tantibanchachai, what's the FDA's official guidance to a person who is on Accutane right now and gets pregnant? Their answer: How to proceed is up to you (the FDA will not recommend an abortion). "There are no statements in the enrollment form or other provisions in the iPledge REMS that require or recommend that a patient agree to an abortion should they become pregnant," Tantibanchachai explains. The practical guidance is to stop Accutane immediately and seek out an OB/GYN: "If the patient becomes pregnant, they must stop taking isotretinoin immediately. The patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling."

Refinery29 reached out to Accutane for comment but representatives from the drug company maintained all of the information on protections are available on the iPledge website.

Wherever you live, in the case of an accidental pregnancy, stop your Accutane, tell your doctor right away, and seek evaluation from an OB/GYN. If you're in a state where abortion is banned, you may be forced to seek care out of state or look into other options like self-managing an abortion.

In the case that you're in the early phases of considering Accutane as an acne treatment, the potential consequence of potential fetal birth defects with no option of abortion may outweigh the benefits, especially if you're in a conservative state that's restricting abortion access . It may be best to proceed with more caution. Even clinics in more liberal states may be more overwhelmed with incoming out-of-state patients, and it may be more difficult to book care in a timely fashion. Even before Roe v. Wade, abortion was inaccessible to many for all kinds of reasons — costs, abusive partners, being a minor with an unsupportive parent, or logistical reasons like getting time off work or finding childcare — more and more people are finding themselves in these situations now.

Though people in states where abortion is totally inaccessible are certainly most at risk. "It's very concerning if you're in a state where abortion is not legal anymore," Dr. Farber admits. In states with abortion bans or trigger laws, Accutane may become too risky to prescribe safely. "I think it's going to be a lot harder to write prescriptions when, at the end of the day, the risk-benefit conversation is very different," Dr. Farber explains. "Because now, the risks include, potentially, a pregnancy that has to be carried to term when there's known birth defects and no access to abortion."

Still, the decision to take Accutane remains a person's prerogative. TikTok user Hailey4874 lives in a red state and is currently on Accutane to treat acne she's dealt with since middle school. "I chose the absolute worst time in human history to be on Accutane," they shared publicly on TikTok. When those in the comments section asked questions, offering alternative, topical therapies, the creator responded: "Yeah, I understand the risks and I still want to take Accutane."

Refinery29 reached out to several dermatologists in Texas and Florida (two states where abortions are prohibited or restricted) but all have declined to comment.

There are many alternative therapies to Accutane. The trouble is that most people who are good candidates for Accutane have already tried them. According to Dr. Farber, the alternative therapies — oral or topical — depend on the patient. She says a prescription medication like Spironolactone is frequently prescribed, as it often helps with the hormonal component of acne. Though it's important to note that Spironolactone has risks as well.

At the end of the day, an Accutane prescription requires a doctor to educate and care for the patient, mitigate the risks, and make sure they understand the potential consequences. "There are a lot of times when Accutane is appropriate, and a lot of times when it isn't," Dr. Farber explains, "and it's my job to tell the patient. What's very frustrating as a physician is to end up in this scenario where [Accutane] is appropriate, but it may become a very different conversation if patients do not have the choice to abort an accidental pregnancy. It is so important that people who can become pregnant have access to the healthcare they need and are able to make informed decisions about what is best for them personally."