As Abortion Access Wanes, Taking Accutane Has Gotten Even Riskier

Even if you've never struggled with acne or set foot in a dermatologist's office, you've likely heard of Accutane. Once the only brand name of isotretetinoin, a vitamin A derivative taken orally, Accutane is now the colloquial term for the medication among patients and dermatologists alike. (Today, the brand Accutane actually no longer exists and isotretinoin is marketed under several others, including Absorica and Myorisan.) Isotretinoin works by shrinking the skin's sebaceous glands, and has been prescribed since it was first approved by the FDA in 1982 for the treatment of severe, stubborn acne, for one very simple reason: It works.

For all of its efficacy, though, Accutane comes with a list of potential side effects — dry skin, dry eyes, and dry mouth are the most common — and regular pregnancy tests are required in order to complete the monthslong treatment. That's because if you were to become pregnant while on Accutane, the side effects could be severe: birth defects, miscarriage, or stillbirth. For decades, the risks — and the surveillance — were worth it. But with new legislation threatening the privacy, reproductive freedom, and gender-affirming care of patients, some acne sufferers and health-care providers are questioning whether Accutane should still be considered the be-all and end-all solution for severe acne — especially when new devices, oral medications, and topical treatments are becoming more and more effective. 

• Shari Marchbein, MD, is a board-certified dermatologist in New York City.
• Kristel Polder, MD, is a board-certified dermatologist in Dallas.
• John Barbieri, MD, is a board-certified dermatologist and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital in Boston.
• David J. Goldberg, MD, is a board-certified dermatologist in New York City and in Hackensack and Hillsborough, New Jersey.
• Stacey Tovino, JD, PhD, is a professor who specializes in health care law at the University of Oklahoma College of Law.
• Kavita Shah Arora, MD, is a board-certified ob-gyn and bioethicist in Chapel Hill, North Carolina, and ​​an associate professor and division director of general obstetrics and gynecology at the University of North Carolina at Chapel Hill.

• The History and Benefits of Isotretinoin
• The 2023 Risks of Isotretinoin
• The Latest Alternatives to Isotretinoin

More than 40 years after its approval, many dermatologists still consider isotretinoin to be the most successful treatment for stubborn acne. "It is the medication that has our greatest chance of 'curing acne,' because we know that there is no [actual] cure," says Shari Marchbein, MD, a board-certified dermatologist in New York City who specializes in adult acne in women. "But it has the greatest chance of giving long-lasting [results] even [after going] off of it."

It's this potential for long-term success that sets isotretinoin apart from other prescription medications and over-the-counter treatments that are typically effective for mild to moderate acne. Isotretinoin is also capable of tackling cystic acne, the most severe type, which can lead to scarring and generally doesn’t respond to other treatments. "Often, at the first sign of inflammatory lesions [that are characteristic of cystic acne] and scarring, we are letting patients know they need to be thinking about Accutane," says Kristel Polder, MD, a board-certified dermatologist in Dallas.

Also contributing to its staying power is the matter of cost: Isotretinoin is often covered by insurance. For a cycle of 30 pills, there may be a small co-pay (usually under $20) or you could pay roughly $120 out-of-pocket, depending on your plan and whether you've met your deductible. Some promising new acne treatments, however, including lasers, may not be covered, says John Barbieri, MD, a board-certified dermatologist and director of the Advanced Acne Therapeutics Clinic at Brigham and Women's Hospital in Boston. (A series of three sessions with the buzzy new AviClear laser, for example, can cost $3,000.) "So even if there's something that might be an alternative, from a practical standpoint, many patients can't afford it," he adds. 

And isotretinoin can streamline your acne regimen. "What I love so much about isotretinoin is that you don't have to use any more creams. You don't need to go on an antibiotic," says Dr. Marchbein. In other words, it's the only medication you need, versus having to combine oral antibiotics or birth control with topical formulas, like prescription retinoids.

Isotretinoin, though, isn't always harmless. Because it works by shutting down your sebaceous glands, it can cause severe dryness on the lips and face. One systematic review found that this dryness affects more than half of isotretinoin patients. The same review also reported other less-common side effects including elevated liver enzymes, headache, decreased appetite, and depressed mood impacting 12 out of 760 patients enrolled in the studies. That's less than two percent of participants, but the side effects were serious enough that patients withdrew from trials. Other purported side effects (not mentioned in this study) include the risk of inflammatory bowel disease and heightened cholesterol levels. 

A key word here, though, is purported. At present, there does not actually appear to be any link between inflammatory bowel disease and isotretinoin. And according to research, isotretinoin may in fact improve mental health. "We have good studies that show us that it usually makes people less depressed and happier because they're not breaking out with bad cystic acne anymore," says Dr. Marchbein.

One side effect that's undisputed, however, is isotretinoin's potential to cause severe birth defects, which research has shown to include both congenital defects and cognitive impairments. It's categorized as a teratogenic drug, which describes any agent that causes abnormality after a fetus is exposed to it. "The data that we have for isotretinoin [shows] that it is absolutely not safe in pregnancy at any amount," says Kavita Shah Arora, MD, a board-certified ob-gyn and bioethicist in Chapel Hill, North Carolina.

This teratogenic classification means that, before starting isotretinoin, a patient must undergo a rigorous screening process in order to access the drug. The screening program, known as iPledge, requires two pregnancy tests (either urine or blood tests), typically spaced 30 days apart — the first done in the doctor’s office and the second at a certified lab, like Quest Diagnostics or Labcorp (or your doctor's office if they have their own lab). Once an isotretinoin regimen has begun (it typically lasts six months but can be shorter or longer depending on the response), patients must have monthly, in-office pregnancy tests. And these testing requirements also apply to women who are not in a heterosexual relationship or people with uteruses who do not identify as women. Dr. Marchbein points out how harmful this can be for the latter group in particular. "For patients who [transitioned from] female to male and are on testosterone, the treatment of choice is often isotretinoin," she explains. “If you identify as a male and you are [undergoing] testosterone therapy, which may cause severe cystic acne, how would you like it if I had to have you come into my office every month, pee in a cup so I can do a urine pregnancy test, give blood so I can do a blood pregnancy test, and have me make you take contraception?” 

And then there's this: All this testing creates a permanent record of a person's menstrual cycle — which can create a fraught situation if you're someone of childbearing age in states where last year's overturning of Roe v. Wade has restricted abortion access. And with abortion bans that classify legal abortions based on the recorded date of conception, a medical record of one's cycle could potentially be used as evidence against someone who's accused of having had an illegal abortion — even after that person's Accutane treatment is completed. 

While HIPAA, a federal law that governs patient privacy, offers some level of protection, it is not guaranteed, says Stacey Tovino, JD, PhD, a professor who specializes in health care law at the University of Oklahoma College of Law. "A health care provider may — but is not required to under the HIPAA Privacy Rule — disclose a patient's medical record to a court pursuant to a court order," explains Dr. Tovino. And if they don't disclose it, the provider could be held in contempt of court, "the consequences of which can vary depending on the judge presiding over the case," says Dr. Tovino. "A particular judge may impose fines and/or jail time, for example, to persuade the party to comply with the court order. Once the contemnor complies (in this case, by turning over records), they will be released from jail."

Some states are particularly litigious: Texas's SB 8 law enables and encourages Texans to report their fellow citizens if they suspect a terminated pregnancy, and doctors are concerned that hospitals in Louisiana will withhold care for a patient who has had a miscarriage for fear of prosecution. 

So, if you live in a red state, is it just too risky to take isotretinoin? In a recent issue of the Journal of the American Academy of Dermatology, a group of dermatologists shared commentary on this exact question and discussed the ethics of prescribing Accutane in a country that's become increasingly hostile toward abortion rights. "Abortion bans limit patient autonomy by preventing pregnant patients on a teratogenic medication the free and informed decision of terminating their pregnancy," write the article's authors. "Therefore, we may harm our patients and their offspring when prescribing teratogenic medications in states where abortion is restricted because these women will have no alternative option if/when contraception fails." The authors, who are all based in states in which abortion access hasn't been impacted by the recent Supreme Court decision, make the argument that dermatologists should consider alternative treatment plans for states in which abortion has been banned.  

Despite its serious drawbacks, isotretinoin has unwavering popularity among the dermatologists we spoke with — including Dr. Polder, who has no qualms about prescribing it to patients despite practicing in Texas, a state that bans abortion at all stages of pregnancy.

For one, she says, pregnancies while on isotretinoin are still relatively rare. "In our practice, we have not experienced a pregnancy on isotretinoin," she says, noting that her practice has been operating for nearly 30 years. (According to a 2019 study of FDA data, the rate of pregnancies among isotretinoin users ranged from 0.33% to 0.65% between 1997 and 2017.)

Part of Dr. Polder's confidence in prescribing it is also due to other safeguards she has in place, such as extensive counseling about its side effects. In addition to iPledge, "I always give patients their options, educate them," she says. "The bottom line is: If a patient needs isotretinoin because of severe acne, we are going to do everything we can to make sure that patient has access to that medication."

This sort of counseling may be key when it comes to navigating the ethics of prescribing isotretinoin in a state where abortions have been banned or limited. Dr. Shah Arora says this medical practice is called "shared decision-making" and it's a core tenet of making ethical health care choices. "In shared decision-making, a patient is given whatever information they need in order to make a sound, informed decision and it's a bidirectional conversation between the patient and their clinician about risks and benefits," says Dr. Shah Arora. "[From an ethics standpoint] it should be a conversation that's tailored to the patient rather than [only] a monthly pledge, a monthly urine pregnancy test, et cetera." And, despite the current strategies in place, she adds that accidental pregnancy does take place. "Every now and then, pregnancies do happen on the iPledge program, which is actually a testament to the fact that no matter what somebody is doing and how safe they are, there still are unintended pregnancies," she says.

There's good news wrapped up in all of this, too. The latest advances in acne treatment now offer alternatives to isotretinoin, meaning patients who are wary of the drug no longer have to choose between risking its side effects or living with cystic acne. Take in-office laser AviClear, which uses a 1762 nanometer laser to reduce the output of sebaceous glands: Clinical studies determined that 91 percent of patients responded to a series of three treatments, with 80 percent seeing half their acne clear. "We now have six-month results on that group and all are even better at six months after the third treatment," David J. Goldberg, MD, a board-certified dermatologist in Hackensack, New Jersey (who participated in studies that led to the laser's FDA approval), previously told Allure. "We have some early data at nine months that shows the results are staying." Of course, there is significantly more evidence — decades-worth — to back up isotretinoin's long-term results but "it does seem like the 1726 nanometer laser can induce a durable remission of acne similar to isotretinoin," says Dr. Barbieri. Although Dr. Barbieri also notes that AviClear is probably not as powerful as isotretinoin and could be better suited to cases of moderate versus severe acne. Cost, too, can be an obstacle: AviClear is not currently covered by insurance, and the three recommended sessions can cost about $3,000, depending on your provider.

Then there's the hormonal approach that Dr. Marchbein relies on to treat people with uteruses, in particular. "Hormones play a very large role in contributing to the breakouts that we get as adult women," she says. "For that, we use things like birth control pills and spironolactone, which is an anti-hormonal medicine." Birth control pills are FDA-approved for the treatment of acne. Spironolactone, which blocks androgen's effect on the skin that ultimately triggers excess sebum production, is not. But it's emerged as an effective way to control adult female acne — so much so that Dr. Marchbein sometimes prefers it to isotretinoin. "If you put a woman on isotretinoin and then take her off — and this is just my own personal experience from doing this for almost 20 years — there's a much higher likelihood of her acne coming back," she says. "I do not consider isotretinoin a cure for adult female cystic hormonal acne because we need hormonal control for these women." Instead, she points to spironolactone and birth control for long-term breakout control and will incorporate isotretinoin as a supplement to these medications if they don’t do the trick. (However, all three work are only options if you're not pregnant or trying to get pregnant.) A birth control prescription can range from $0 to $50 per month, while a spironolactone prescription can cost about $5 for 30 pills, depending on your insurance and pharmacy. 

Losing steam, meanwhile, are oral antibiotics, which were once considered to be a safe bet for treating certain types of acne. "But they come with some risks of disrupting the microbiome or antibiotic resistance," says Dr. Barbieri. As we've learned more about the microbiome of both the skin and the gut — and the essential role it plays in bolstering the immune system, regulating mood, and more — bacteria have taken on outsize importance. And oral antibiotics, as their name implies, work by obliterating bacteria, including (but not limited to) the C. acne strain that contributes to breakouts. They've proven to be an inelegant approach that Dr. Barbieri and Dr. Marchbein occasionally use for a month or two, depending on the patient, but don’t see as a long-term solution. 

And there are elegant topical formulas that tend to be best for mild to moderate acne, according to Dr. Barbieri. "Or you could have someone who has more severe acne, but they don't want to have side effects or they're scared of pills," he says. "So, let's try the best topical regimen we can do. And if we get good enough results, great." These topical treatments are often used together, using different active ingredients to target the various contributors to acne: over-the-counter benzoyl peroxide tackles bacteria, while topical retinoids prevent dead skin cells from piling up in pores and eliminate a food source for bacteria. ​There's also a new prescription topical treatment called clascoterone (brand name Winlevi). "It's a topical anti-androgen that addresses the role of hormones on the sebaceous glands," says Dr. Barbieri, who has found a one-two-three punch of benzoyl peroxide, a retinoid, and Winlevi make for "a really good topical regimen." You can often find benzoyl peroxide cleansers for less than $10, and retinoids like Differin cost around $20. The cost of Winlevi is steeper, and will vary depending on your insurance, but could range from $482 to $672. 

Ultimately, whether you're interested in a new skin-clearing laser or decide you're willing to tolerate isotretinoin's new risks, you have more choices than ever before — on the acne-treatment front, at least.

Acne is hard — and when you're an adult with acne, it can be especially frustrating when much of the information out there doesn't take into account the nuances of treating it in adulthood. This story is part of Allure’s Adult Acne Guide, which includes the best tips and product recommendations for treating adult acne. From the products dermatologists use on their own breakouts to first-person reviews of the newest, most promising in-office treatments for stubborn hormonal acne, we’ve got you covered. 

Read more about acne treatments here: 

• How To Treat Every Type of Adult Acne at Home
• 5 Dermatologists with Acne Share Their Own Skin-Care Routines
• My Hormonal Acne Journey With Winlevi

Now, watch a Howard University dance captain's beauty routine: