Isotretinoin: Treatment for severe acne

Acne can diminish quality of life: Studies show that acne can decrease self-confidence and cause one to avoid social situations.

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:

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

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

Take required pregnancy tests before and while taking isotretinoin.
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:

Disease that affects your immune system, such as HIV, AIDS, rheumatoid arthritis (RA), psoriasis, or graft vs. host disease.
Allergies.
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:

Any medicine (include ones you buy without a prescription, such as aspirin).
Vitamins.
Minerals.
Herbal supplements.
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:

iPLEDGE Program
AADA position statement on isotretinoin
BeSafeRx: Know your online pharmacy

Before and after taking isotretinoin: This woman treated cystic acne for years without success (left). After taking isotretinoin, her skin cleared (right).

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:

Do not start taking isotretinoin while pregnant.
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:

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

Take the required pregnancy tests.
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:

Severe birth defects.
Miscarriage (baby dies before birth).
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:

Bad headache.
Blurred vision.
Dizziness.
Nausea or vomiting.
Seizures (convulsions).
Stroke.

More common and less serious side effects are:

Dry eyes.
Dry skin.
Chapped lips.
Nasal passage so dry that nosebleeds occur.
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:

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

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

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

Isotretinoin: Patient safety

News of lawsuits and frightening side effects can make one wonder why a dermatologist would prescribe isotretinoin (eye-soh-tret-in-OH-in)¹. Furthermore, why would anyone take it to treat acne? There really is more to the story.

Effective when nothing else works

Dermatologists prescribe isotretinoin for severe acne. Severe acne is often very painful. When the painful cysts and nodules of severe acne clear, they leave permanent scars. Many people who have severe acne feel depressed. Some feel anxious. Low self-esteem often develops. Grades can plummet, and job performance can suffer.

Clearing severe acne greatly improves many people’s lives. Most acne treatments, however, have little effect on severe acne.

Isotretinoin can clear severe acne when other treatments fail. With just one treatment, isotretinoin can permanently clear the skin. One treatment typically lasts 4 to 5 months. If a dermatologist prescribes a lower dose of isotretinoin, the treatment may last longer. About 85% of patients see permanent clearing after one treatment.

Isotretinoin is strong medicine. It has the potential to cause some serious side effects. That’s why dermatologists carefully evaluate each patient. They weigh the pros and cons before prescribing isotretinoin. They carefully monitor every patient taking this medicine.

Dermatologists carefully evaluate patients

Before prescribing isotretinoin, dermatologists ask questions about the patient’s physical and mental health. They ask what medicines, vitamins and herbal supplements the patient takes. If everything looks okay, the patient must get a few medical tests. Everyone needs a blood test. Women who can get pregnant must have pregnancy tests. Women need 2 negative pregnancy tests before isotretinoin can be prescribed.

Before prescribing isotretinoin, the dermatologist looks at the test results. If the results are okay, the dermatologist will discuss possible side effects of isotretinoin. After learning about isotretinoin, a patient must decide whether to take this medicine.

If the patient wants to take it, the patient must agree to the strict terms of the iPLEDGE program. iPLEDGE was created to help patients take this medicine seriously. The terms that the patient must agree to include:

See the dermatologist every 30 days.
Take the necessary medical tests.

Patients carefully monitored

The office visits and medical tests allow a dermatologist to look for early warning signs of possible side effects and determine how well the medicine is working. The dermatologist will look for signs of depression, inflammatory bowel disease, and other possible side effects.

Before writing the next prescription, the dermatologist must be convinced that the patient is doing well and following iPLEDGE.

Depression and isotretinoin

Many people worry that isotretinoin can cause mental health conditions. There have been reports of patients developing depression, seeing and hearing things that are not real, and having thoughts of suicide while taking isotretinoin. You may have heard such reports in the news.

Dermatologists take these reports seriously. That’s why dermatologists are conducting research studies to find out whether isotretinoin is directly responsible. Proving or disproving this is not as easy as it sounds. One reason is research shows that people who have severe acne often become depressed. This is true for people who have never taken isotretinoin.

Because we do not have enough evidence to tell whether this medicine can cause depression and other mental health conditions, dermatologists carefully monitor their patients for warning signs of depression and other mental health conditions.

Dermatologists also recommend taking precautions. If a person taking isotretinoin has any symptoms of depression or another mental health condition, the person must stop taking isotretinoin right away.

Inflammatory bowel disease and isotretinoin

Inflammatory bowel disease (IBD) is another concern. There have been reports of patients developing IBD while taking isotretinoin. Again, there is not enough scientific evidence to determine whether isotretinoin is actually the cause. More research is needed.

If a patient develops any of the following signs or symptoms of IBD, the patient must stop taking isotretinoin and see a doctor:

Severe stomach or bowel (intestines) pain.
Diarrhea.
Bleeding from rectum.
Yellowing of skin or eyes.
Dark urine.

Patient safety is the first priority

Isotretinoin is an important medicine. It can clear severe acne that does not respond to any other treatment. As acne clears, a patient’s quality of life often greatly improves. Dermatologists are committed to the safe and responsible use of this medicine. Patient safety is a dermatologist’s first priority when prescribing isotretinoin.

¹Isotretinoin is the generic name for this drug. Many people know this drug by the brand name Accutane, which is no longer available. Isotretinoin is available through other brand names.

References

American Academy of Dermatology and AAD Association, “Position Statement on Isotretinoin, (last update November 13, 2010).
American Academy of Dermatology, “AADA introduces updated isotretinoin position statement.” News releases issued November 22, 2010.
Chiu V, Cheng A, Oliver D, “Isotretinoin and association with depression.” Presented as a poster (P704) at the 68th Annual Meeting of the American Academy of Dermatology, March 2010; Miami.(Commercial support: None identified).
Hodgkiss-Harlow CJ, Eichenfield LF, Dohil MA. “Effective monitoring of isotretinoin safety in a pediatric dermatology population: A novel "patient symptom survey" approach.” J Am Acad Dermatol; 2011; 65: 517-24.
Crockett SD, Gulati A, Sandler RS et al. “A causal association between isotretinoin and inflammatory bowel disease has yet to be established.” Am J Gastroenterol 2009; 104: 2387-93.
Goldsmith LA, Bolognia JL, Callen JP et al. “American Academy of Dermatology Consensus Conference on the safe and optimal use of isotretinoin: summary and recommendations.” J Am Acad Dermatol 2004; 50: 900-6.
Magin P, Pond D, Smith W. “Isotretinoin, depression and suicide: a review of the evidence.” Br J Gen Pract 2005; 55: 134-8.
Strauss JS, Krowchuk DP, Leyden JJ et al. “Guidelines of care for acne vulgaris management.” J Am Acad Dermatol 2007; 56: 651-63.
U.S. Food and Drug Administration (FDA), “The iPLEDGE Program Patient Introductory Brochure” (pdf), December 2007.
Wysowski DK, Beitz J. Methodological limitations of the study "Isotretinoin use and risk of depression, psychotic symptoms, suicide, and attempted suicide". Arch Dermatol 2001; 137: 1102-3.
Wysowski DK, Pitts M, Beitz J. “An analysis of reports of depression and suicide in patients treated with isotretinoin.” J Am Acad Dermatol 2001; 45: 515-9.

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