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Isotretinoin: Treatment for severe acne

Isotretinoin: Overview

Brand names: Absorica®, Accutane®, Amnesteem®, Claravis®, Myorisan®, Sotret®, and Zenatane™

Isotretinoin (eye-soh-tret-in-OH-in) is a prescription medicine for severe acne. This type of acne causes deep, painful cysts and nodules. These can be the size of a pencil eraser — or larger. As this acne clears, scars often appear.

Severe acne can be difficult to treat. When other treatments fail to clear the skin, isotretinoin may be an option. About 85% of patients see permanently clear skin after one course of treatment with isotretinoin.

Warning: You put your health at serious risk when you buy this medicine from an online site that does not require a prescription.

One course of treatment takes about 4 to 5 months. Sometimes, one course of treatment takes less time or a bit more time. Dermatologists tailor the treatment to each patient. 

Due to possible side effects, your dermatologist can only prescribe this medicine if you: 

  1. Enroll in iPLEDGE™, a program from the U.S. Food and Drug Administration (FDA).
  2. See your dermatologist for follow-up visits.
  3. Sign forms that state you know the risks of taking isotretinoin.

Patients who can become pregnant must take a few extra precautions:

  1. Take required pregnancy tests before and while taking isotretinoin.
  2. Avoid getting pregnant.

Patient safety is a dermatologist’s first concern. If this medicine is an option for you, your dermatologist will talk with you about how to take this medicine safely and what you can expect. You and your dermatologist should jointly decide whether this medicine is right for you.

If isotretinoin is an appropriate treatment for you, you will be under close medical supervision while you take this medicine.

Isotretinoin: Benefits and risks

This medicine treats many patients safely and effectively. It is, however, not right for everyone. You should discuss the benefits and risks with your dermatologist.

When you talk with your dermatologist about isotretinoin, be sure to tell your dermatologist if you have any of the following:

  1. Disease that affects your immune system, such as HIV, AIDS, rheumatoid arthritis (RA), psoriasis, or graft vs. host disease.
  2. Allergies.
  3. Plans to become pregnant — or are pregnant or breastfeeding.

“Isotretinoin offers our patients who have severe acne significant, life-changing benefits. Providing this medicine safely is our top priority.”— Dermatologist William D. James, MD, FAAD

You also should tell your dermatologist if you take:

  1. Any medicine (include ones you buy without a prescription, such as aspirin).
  2. Vitamins. 
  3. Minerals.
  4. Herbal supplements. 
  5. Any other acne treatment, including antibiotics.

Be sure to tell your dermatologist about all acne treatments that you have used in the past and the results from each.

Talk with your dermatologist about concerns

If you have any concerns about taking isotretinoin, you should tell your dermatologist. Dermatologists have been prescribing this medicine for years. In fact, dermatologists led many of the clinical trials for isotretinoin. This makes dermatologists very familiar with the medicine and knowledgeable about who it can help.

Dermatologists continue to lead research studies that look at how isotretinoin can help improve the lives of their patients.

Related resources:

  1. iPLEDGE Program
  2. AADA position statement on isotretinoin
  3. BeSafeRx: Know your online pharmacy

Isotretinoin FAQs

Will isotretinoin cure me?

About 85% of patients see their skin permanently clear after one course of treatment. A course of treatment generally lasts about 4 to 5 months. It can run shorter or longer. 

Some patients do not clear after one course of treatment, and a second course of treatment may be an option. Studies show this helps some patients see clear skin. You should wait at least 8 weeks between treatments. The skin often continues to clear for a while after patients stop taking the medicine. 

How do I use isotretinoin?

This medicine comes in pill form. You will take one or two pills a day as your dermatologist prescribes.

Before taking isotretinoin, you must enroll in the iPLEDGE™ program. Created by the U.S. Food and Drug Administration (FDA), this program helps to ensure that patients:

  1. Do not start taking isotretinoin while pregnant. 
  2. Do not become pregnant while taking isotretinoin.Because iPLEDGE™ informs patients about other possible side effects, all patients must enroll in this program before taking isotretinoin.

How long will I have to take isotretinoin?

One course of treatment generally takes about 4 to 5 months. You may need a shorter or longer treatment time.

How does isotretinoin work?

 This is the only acne treatment that attacks all four causes of acne — excess oil production, clogged pores in the skin, too much of the bacteria P. acnes, and inflammation. This makes isotretinoin very effective.

Do I need to take any precautions while using isotretinoin?

Yes. You will need to learn about the potential side effects before you decide whether to take isotretinoin.

If you and your dermatologist decide that this medicine is right for you, you will need to do the following: 

  1. Enroll in the iPLEDGE™ program.
  2. Return to your dermatologist every month for a follow-up appointment. 
  3. Immediately report any possible side effect to your dermatologist.
  4. Do not wax to remove hair while taking this medicine — and for 6 months after you stop taking isotretinoin.
  5. Protect your skin from the sun and do not use a tanning bed, sun lamp, or other indoor tanning device. 
  6. Do not donate blood while taking isotretinoin and for 30 days after you take your last pill.

Females only

Patients who can get pregnant also need to take the following precautions:

  1. Take the required pregnancy tests.
  2. Use 2 approved forms of birth control.

What are possible side effects?

A number of possible side effects can occur while taking this medicine. It is essential that a woman not take this medicine while pregnant and not become pregnant while taking this medicine. Isotretinoin can cause:

  1. Severe birth defects. 
  2. Miscarriage (baby dies before birth).
  3. Premature birth.

Other potential side effects include:

Depression: A connection between taking isotretinoin and developing symptoms of depression/anxiety has been suggested. Dermatologists take reports of depression seriously. Results from some studies, however, show that sometimes patients treated with isotretinoin have fewer symptoms of depression and anxiety. These patients also have improved quality of life.

Inflammatory bowel disease (IBD): There have been reports of patients developing IBD after taking isotretinoin. IBD includes Crohn’s disease and ulcerative colitis. To date, research has not found strong evidence to prove this. Results from a recent, large-scale study that looked at this possible connection suggest otherwise. In this study, which involved thousands of patients, taking isotretinoin did not increase the risk of IBD.

The risk of developing IBD may be linked to having severe acne. More studies are required.

Thoughts of hurting yourself or suicide: Research is needed to find out whether these would have occurred if the person had not been taking isotretinoin.

Other serious side effects that have been reported include:

  1. Bad headache.
  2. Blurred vision.
  3. Dizziness.
  4. Nausea or vomiting.
  5. Seizures (convulsions).
  6. Stroke.

More common and less serious side effects are:

  1. Dry eyes.
  2. Dry skin.
  3. Chapped lips.
  4. Nasal passage so dry that nosebleeds occur.
  5. Diminished ability to see in the dark.

The AAD believes that this medicine can be appropriate treatment for severe acne, as long as prescribing doctors educate their patients about the potential risks. Patient safety is dermatologists’ primary concern. Dermatologists monitor their patients for IBD, depression, and other possible side effects.

Is it safe to remove hair with wax while taking isotretinoin?

No waxing, please. Waxing can cause permanent scars in people taking isotretinoin. To avoid scarring, you must not wax while taking isotretinoin and for 6 months after you stop taking isotretinoin. This applies to hot wax and cold wax.

Does isotretinoin increase risk of sunburn?

If you plan to spend time outdoors, it is important to know that isotretinoin can make your skin more sensitive to the sun. You can sunburn unexpectedly and quickly. To protect your skin, dermatologists recommend that people taking isotretinoin:

  1. Seek shade when outdoors.
  2. Wear a shirt, wide-brimmed hat, and pants.
  3. Apply sunscreen to all skin that will be exposed.

The type of sunscreen you use is important. Be sure to use sunscreen that offers:

  1. Broad-spectrum protection (bottle may say “UVA/UVB protection”).
  2. An SPF of 30 or greater.
  3. Water resistance.

Because isotretinoin can make your skin more sensitive, it is especially important that you not tan. This includes not using indoor tanning (sunlamps and tanning beds) while taking isotretinoin.

References:

Elminan M, Bird ST, Delaney JA et al. “Isotretinoin and Risk for Inflammatory Bowel Disease.” JAMA Dermatol. 2013 Feb 1;149(2):216-20.

Images used with permission of the American Academy of Dermatology National Library of Dermatologic Teaching Slides.