- Isotretinoin (Claravis, Amnesteem, Absorica, Myorisan, and formerly Accutane) is a powerful, oral retinoid treatment for severe or recalcitrant cases of acne.
- Oral isotretinoin comes with a host of side effects, and has been proven to cause birth defects when taken by pregnant women.
- Talk to your doctor about isotretinoin’s risks, benefits, side effects, and drug interactions before making the decision to undergo this treatment.
If you’ve long struggled with chronic acne, there’s a good chance that you’ve already discussed Accutane (isotretinoin) with your healthcare provider. This treatment can provide dramatic benefits for people with cases of moderate to severe acne. In fact, according to the American Osteopathic College of Dermatology (AOCD), isotretinoin can fully clear away acne within four to five months.
But if you’ve looked into the medication, you also know that it also has some serious downsides. Birth defects, depression, suicidal thoughts, nosebleeds, vomiting: all of these side effects have been associated with the drug.
The brand-name Accutane, from Hoffmann-La Roche, was actually discontinued in the United States. However, there are still various generic versions and one brand available (Absorica) that have been approved by the U.S. Food and Drug Administration (FDA).
What is Isotretinoin?
Isotretinoin (13-cis-retinoic acid) is a naturally-occurring derivative of vitamin A. The difference between the vitamin A that naturally occurs in your body and the kind found in isotretinoin is that the latter is much more potent.
The full pharmacologic activity, or method of action, of isotretinoin is not yet fully understood, but there are several things we do know about the drug and how it works. The high doses of vitamin A help to thoroughly reduce sebum (oil) production that can clog the pores and cause acne. It also effectively shrinks oil glands and delays the production of cells that clog the pores, while simultaneously killing bacteria that leads to blemishes and acne.
Retinoids also provide anti-inflammatory effects, which can help curb some acne symptoms like redness, irritation and puffiness.
Isotretinoin can be used to treat various types of acne. It’s particularly beneficial for people with the most severe forms of the condition, like cystic acne and nodular acne. The drug is also used to treat skin issues such as erythema dyschromicum perstans and dissecting cellulitis.
Your doctor may prescribe topical or oral isotretinoin, depending on the severity of your acne and health record.
The Upsides of Accutane
Accutane can quickly and effectively cure some of the most hard-to-treat skin disorders and has transformed the lives of many patients, with few reported side effects.
The medication has especially been touted as a wonder drug for severe acne sufferers, and has the unique ability to target stubborn acne cysts. Approximately 80% of patients who take the medication achieve remission from acne.
For most people the risks of taking Accutane appear minimal, with the pros far outweighing the cons. This is especially true for those who suffer from debilitating cystic acne and other extreme forms of the condition, all of which can compromise a person’s self-esteem and sense of well-being.
Isotretinoin and Pregnancy: iPledge
One of the most concerning adverse effects associated with isotretinoin is its effect on pregnant women.
According to the U.S. Food and Drug Administration (FDA) and the Birth Injury Guide, isotretinoin is classified as a Category X drug — meaning it should never be taken by pregnant women — because it has been shown to cause a high numbers of birth defects when taken at any point during pregnancy.
In fact, women of childbearing age who agree to undergo isotretinoin therapy must enroll in a risk management program called the iPledge Program. Under this program, female patients must agree to be abstinent or use two forms of birth control, and procure negative pregnancy tests every month they take the medication.
Once the patient has taken a pregnancy tests showing negative results, a healthcare provider can begin the treatment. However, it can’t be started until she answers some basic sex education questions and enters two forms of birth control into the iPledge Program, either online or by calling their hotline.
Each additional month of treatment and 30 days after the treatment has been completed, the patient is required to prove she isn’t pregnant, consult with her provider, and answer the iPledge questionnaire. Female patients may also have to sign a consent form in order to take the medication every month.
Under regulations set by iPledge, a negative pregnancy test is required 30 days after the treatment has ended. At that point no additional tests are required. Note that the treatment has no effect on future pregnancies, since the body quickly and effectively rids itself of the drug within days. Because of this, one can assume the medication has completely exited the body and will not inflict harm on a future fetus.
If a female patient is unable to get pregnant (i.e. post-hysterectomy, postmenopausal, transgender from male to female), then the regulations are lightened to those required by male patients. Bloodwork is still advised on a monthly basis, however.
Isotretinoin and Mental Health
One of the most disconcerting side effects associated with isotretinoin is that many patients experience depression.
Case reports have linked the medication with suicide attempts and serious psychiatric disorders. In 1998, the FDA issued a warning to physicians regarding the link between the drug and depression, psychosis and suicide.
In 2000, former Rep. Bart Stupak [D-MI1, 1993-2010] claimed that his son — a football star and popular student — committed suicide because of his treatment with Accutane, citing no other plausible triggers.
While there remains no proven link between isotretinoin and suicidality, studies suggest anywhere between one and 11 percent of isotretinoin patients report feelings of depression.
High amounts of vitamin A can lead to toxicity (hypervitaminosis A), which can alter the way our bodies and brains function. Consequently it’s sometimes recommended that patients curb their intake of vitamin A while on the medication.
Some doctors also recommend avoiding large amounts of leafy greens like kale, multivitamins containing vitamin A, and eating too many carrots and sweet potatoes while undergoing isotretinoin treatment.
Some providers will agree to prescribing isotretinoin to patients with an existing or prior history of mental health issues, so long as the patient has a mental health professional agreeing to monitor them while they’re on the medication.
The most important thing to consider before determining whether a drug can affect your mental health is to talk with your doctor about existing symptoms and discuss whether a new medication could worsen them.
Isotretinoin and Inflammatory Bowel Disease
According to recent studies, there is no clear evidence of a causal link between isotretinoin and inflammatory bowel disease (IBD).
In one study, it was determined that higher doses of isotretinoin appear to augment the risk of ulcerative colitis — a chronic bowel disease causing inflammation of the digestive tract — but do not cause Crohn’s disease or IBD.
Isotretinoin may have temporary negative effects on the gastrointestinal system, such as nausea, dry throat and diarrhea.
More Common Side Effects of Isotretinoin
The majority of the cases noted above are considered extremely rare due to the FDA requirement for clear labeling and programs such as iPledge.
However, many more patients experience less severe side effects from taking isotretinoin, the most common being dry skin, dermatitis, dry eye and the occasional bloody nose.
Note that the following list is by no means comprehensive, and that you should request a complete list of side effects from your doctor before taking the medication.
- Skin Disorders
One of the most common side effects associated with isotretinoin is dry skin. Other common conditions include hair loss, cheilitis (inflamed or dry lips), dermatitis (rash), pruritus, dry mouth and increased sun sensitivity. Make sure you use a high-quality sunscreen and a quality moisturizer alongside this medication.
- Aches, Pains and Headaches
Many people experience joint pain, stiffness, back pain, headache, pain behind the eyes and other aches while on isotretinoin. It can also trigger severe stomach pain, which sometimes spreads to the lower back and occurs alongside nausea and vomiting.
- Blood Disorders
Another common side effect associated with isotretinoin is increased triglyceride levels, or a higher potency of fat in the blood. This can raise the risk of heart disease, high blood pressure, diabetes and stroke. Many people who take the medication also develop anemia, lowered or heightened levels of blood platelets and increased red blood cell rates.
- Eye and Vision Problems
While rare, isotretinoin can cause raised pressure in the brain, triggering loss of eyesight and blurred vision. Other people have reported issues with poor night vision and other changes in eyesight. Eye pain, redness and an irritation similar to seasonal allergies can occur.
- Other Side Effects
Patients may also experience hearing problems, numbness, weakness, seizures, severe diarrhea, fever, chills, body aches, blistering, red skin rash, loss of appetite, moodiness and allergic reactions. If any of these symptoms persist, make sure to see your doctor right away.
Isotretinoin Drug Interactions
As with any drug, isotretinoin can cause side effects when combined with other medications.
There are approximately 20 major drug interactions that can affect the efficacy and performance of isotretinoin. Among the medications and supplements that can negatively interact with Accutane are tetracycline, acetaminophen, progesterone, St. John’s Wort, phenytoin, the aforementioned vitamin A, and some corticosteroids.
Make sure to be very clear with your dermatologist about all of the prescription and over-the-counter medications you regularly take. He or she will be able to determine whether or not these medications pose higher risks or create negative interactions when taken with isotretinoin.
The Bottom Line
Although Accutane and other isotretinoin medications are among the most effective treatments for severe and hard to treat acne, this medication comes with a host of considerations that must be thoroughly evaluated before initiating treatment.
Discuss the reported risks and side effects with your doctor to ensure that beginning an isotretinoin treatment will not worsen existing medical conditions you might have, or trigger any new ones. In most cases, doctors will recommend starting lower-risk acne treatments before prescribing isotretinoin.