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1 Question, 5 Answers: Why Is Accutane Such a Closely Monitored Drug?

Isotretinoin is better known as Accutane, even though the brand-name version was pulled from shelves in 2009. It’s a powerful and effective oral medication approved only for people who haven’t seen results from other prescription acne drugs.

A course of treatment lasts four to six months and requires close medical supervision. As with any drug, isotretinoin comes with risks: birth defects, depression and irritable bowel syndrome, in addition to more common side effects like severe skin and lip dryness. Because of this, the current process to fill a prescription is tricky and labor-intensive.

All patients taking isotretinoin must take a monthly blood test to ensure healthy cholesterol levels. Female patients additionally have to enroll in the iPledge program, a risk-management system that aims to prevent pregnancy on isotretinoin. iPledge requires female patients to report to their dermatologist’s office every month for a pregnancy test, confirm two forms of birth control with their doctor and then answer questions about birth control on the iPledge website.

What’s with all the precautionary measures? Who are they protecting? Five doctors sound off.

Dina D. Strachan, MD

Dermatologist, Aglow Dermatology
New York City

Isotretinoin is perhaps the best drug in dermatology — but it must be treated with respect.  Patients can enjoy the benefits of potentially clearing their acne for the long term. However, avoiding and managing side effects such as teratogenicity [the way it impacts fetal development], liver inflammation, visual changes and sudden severe elevations in triglycerides is important. Isotretinoin side effects are similar to those of high-dose vitamin A. It’s like going to the edge of toxicity for therapeutic benefit.

Anisha Patel, MD

Assistant professor of dermatology, McGovern Medical School

I think the main reason that it is monitored so heavily is because of the pregnancy aspect, given the age group the drug is targeted toward. That’s the genesis behind why the iPledge program exists. It’s interesting because my practice is specific to cancer patients, and there are some cancer-therapy side effects where you get really bad acne. The close monitoring of this drug makes it very difficult to give it to patients who are are elderly and/or live out of state. It limits how we can prescribe it to a patient.

Cameron Rokhsar, MD, FAAD

Associate professor of dermatology, Mount Sinai Hospital
New York City

I think it’s a life-changing drug in that it cures acne. The lab monitoring is for patients’ safety. I don’t think [administering the drug without supervision] will ever happen because of the numerous side effects. The goal of the iPledge program was to minimize the chance of a patient getting pregnant while on Accutane. Up to 25 percent of patients who take the drug and get pregnant may have birth defects.

It can also affect your triglycerides and your cholesterol, so we check for those as well in the blood work we do monthly. Dryness, including of the eyes and inside the nose, is the most common side effect. Others include muscle pain, hair loss, changes in vision, headaches and getting sunburned more easily.

There’s a lot of monitoring, but it’s a revolutionary drug.

Joshua Zeichner, MD

Director of cosmetic and clinical research in dermatology, Mount Sinai Hospital
New York City

Isotretinoin is the best treatment that we have for resistant, severe acne. It is regulated by the government because it can cause birth defects in women who get pregnant while they are on it. Despite potential side effects, it is very safe when used properly and patients are regularly monitored. It works by reducing the production of oil in the skin, lowering levels of acne-causing bacteria, preventing cells from sticking together and blocking the pores, and finally by reducing inflammation. The most common side effects are dryness of the skin and lips. The drug can also affect your liver and raise your cholesterol, so your doctor will monitor you every month.

Marc Glashofer, MD

New Jersey

It’s a fantastic medication when used appropriately. So why does Isotretinoin have bad PR, so to speak? For starters, it can cause birth defects in women who take it and get pregnant. That’s what ended up happening about 20 years ago. The iPledge program makes it so that it’s virtually impossible to get pregnant on this drug. It’s understandable that with the extra stumbling blocks created by the iPledge program, it makes people nervous. Isotretinoin is easier to get if you’re a guy, but you still have to enroll in the iPledge program. It makes prescribing the medication extremely hard, and it scares off patients.

There were a couple kids in the ‘80s who took Accutane and [died by] suicide. The press ran with that, and it turns out that there is not a correlation. Studies have been done that show Accutane does not cause depression and mood changes. You need to provide data to patients and parents. Most people come back to us down the road and say, “Thank god I went on this medication. I was depressed because my acne was so bad. Now I have more confidence.”

Responses have been condensed and lightly edited. 

Show Comments (2)
  1. Jesper Gardell

    Misleading and idiotic article. Isotretinoin cause depression through several mechanisms (mostly P53 activation.
    The author is uneducated and should catch up on some of the information available regarding isotretinoin.

  2. Travis

    I find the whole experience to be frustrating and ridiculous. They are requiring so many pregnancy tests and crap for my daughter who just turned 13. She is not even close to being sexually active, and they are asking her to go to this website and attest every month to two kinds of birth control being used? I find that to be abusive. The only birth control she is using is not having sex. I mean come on, she has taken a narcotic in the past for ADD and there wasn’t near this amount of BS associated with it.

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