Is Microdosing Accutane Safe? Dermatologist Weighs In

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While isotretinoin (Accutane) is an incredibly effective acne medication, the intense side effects lead some patients to microdose the medication off-label.

Isotretinoin is a very concentrated form of vitamin A that shrinks the sebaceous glands, reducing oil production, and is most often prescribed for acne, explained Raman Madan, MD, a dermatologist with Northwell Health in Glen Cove, New York, in an interview with MedPage Today in which a press person was also present.

The medication also boosts collagen and can help with anti-aging since reducing oil production helps prevent the skin from sagging. It’s similar to the topical cream tretinoin, but Madan noted that isotretinoin works better due to its systemic nature and most patients’ persistent acne woes are solved with the oral drug.

A person’s target isotretinoin dose depends on their weight, and usually falls in the range of 120 to 150 mg/kg of body weight. Depending on how a patient responds, they may need a higher or lower dose.

“When people go a month without breaking out with acne, then they’ve kind of met their goal dose,” Madan said, adding that the timeline for reaching that dose matters less. “There’s a certain dose that everyone’s body needs, and whether it gets into your body over 6 months or over 6 years, you’re going to get to the same endpoint.”

Madan explained that he usually starts patients with 20 mg a day for the first month, and bumps it up to 40 mg a day for the second month, then 40 mg twice a day to finish the treatment. Some people are more sensitive to side effects, so this treatment plan depends on how well a patient’s body tolerates the medication. Full-dose isotretinoin can cause very dry and sensitive skin, nose bleeds, and cracked lips. Less commonly, patients experience body aches, mood changes, and upset stomachs.

“You kind of have to power through on your Accutane if you’re taking it the way you’re supposed to,” Madan noted. People may end up on the treatment for months longer than others if they have to take a lower or less frequent dose.

Madan said that microdosing isotretinoin is “very, very popular” and that people approach it in a few different ways. Some people take a dose, varying from 10 to 40 mg, every 2 to 3 days while others take it once a week or even once every other week.

“It is, in my opinion, a great way to take Accutane for a longer period of time and kind of reap all the benefits that you get from it,” he added.

However, there’s a catch. Isotretinoin is a powerful medication that can cause severe fetal defects if taken while pregnant. Patients are advised to wait 3 months after completing treatment to get pregnant. Because of these teratogenic effects, isotretinoin is highly regulated and getting a prescription is an involved process.

Patients must register in the iPLEDGE risk evaluation and mitigation strategy (REMS) program, first approved in 2005 and later updated in 2010. Earlier this year, the FDA dropped some REMS requirements for isotretinoin. Still, reproductive-age women must take pregnancy tests in a medical setting before obtaining a prescription and continue taking a pregnancy test once a month throughout treatment.

“The iPLEDGE system, in my opinion, is such a barrier to getting Accutane,” Madan said, calling the system “overkill.”

“Without the iPLEDGE system, I think people would be prescribing it a lot differently,” he added.

If a reproductive-age female patient is microdosing isotretinoin by taking it off-label less frequently for longer, Madan said “the one thing that can slip through the cracks is there’s no monitoring system to make sure you’re not getting pregnant.” He noted that higher doses are more likely to cause birth defects, “but I would never take any chances with even taking one pill if you’re planning on pregnancy.”

Because microdosing isotretinoin is off-label, patients stretch their 30-day supply, often without support and guidance from their physician. If a prescriber is caught fudging the iPLEDGE system, they can lose isotretinoin prescribing privileges. In order to microdose with the support of their dermatologist, reproductive-age women would have to take a pregnancy test every month, which many patients find tedious and time consuming.

“It is a serious medication, and you do have to be careful when you take it … but I think the barriers to patients getting it … can be a little bit burdensome,” Madan said.