Accutane is a prescription drug used to treat severe acne, as well as skin cancer in some rare cases. The main active ingredient in Accutane is isotretinoin, which is sold today under many other brand names, including Absorica, Amnesteem, Claravis, Myorisan, Sotret, and Zenatane. The Accutane brand was discontinued in 2009 by Hoffmann-La Roche, but the company still markets isotretinoin in other countries under the brand name Roaccutane.

Accutane has been known to cause a range of harsh side effects, including severe birth defects and mental health issues. When taken during pregnancy, Accutane can lead to a miscarriage or premature birth, birth defects in newborns, and the newborn’s death. The Centers for Disease Control and Prevention (CDC) advise women not to take Accutane while pregnant.

What Consumers Should Know About Accutane

Accutane is used to treat nodular acne or severe cystic acne, both of which can cause the skin to break out in red, swollen lumps that are often larger than normal acne. Severe acne can last for months and may lead to permanent scarring if left untreated. Accutane is often prescribed when other treatments (like antibiotics) are ineffective. In rare cases, Accutane may also be used to treat mild or moderate acne, other skin conditions, and even some types of skin cancer.

Accutane affects the way that acne develops in a few different ways:

  • By reducing the size of the skin’s oil glands by as much as 58%
  • By reducing the production of oil by up to 80%, which leads to less bacteria on the skin
  • By reducing inflammation

Unless your doctor gives other instructions, Accutane generally is taken twice per day with a substantial meal to help the body absorb the drug. You should always swallow the capsule whole with a glass of water, since isotretinoin can irritate the esophagus if chewed, sucked, or allowed to dissolve in the mouth.

Your doctor will give you a specific dosage according to your weight, but this dosage can change over the course of your treatment – never take a higher dosage than your healthcare professional prescribes. If you forget to take one of your daily doses, always skip that dose instead of taking two doses at the same time. Overdosing on Accutane can lead to serious health problems.

Accutane derives from vitamin A and occurs naturally, which means the body can eliminate the drug relatively quickly from the bloodstream.

Is Isotretinoin a Natural Substance?

Isotretinoin belongs to a class of compounds known as retinoids, which are chemically related to vitamin A. It is produced naturally in very small amounts in the body; however, the isotretinoin found in Accutane and other drug brands is synthesized using commercial manufacturing processes.

Some of the side effects associated with isotretinoin are similar to vitamin A toxicity (hypervitaminosis). Due to its close relationship with vitamin A, isotretinoin should not be taken at the same time as dietary supplements containing vitamin A. You should talk to your doctor or pharmacist about any other possible drug interactions, as well.

FDA Accutane Warnings and Actions

The U.S. Food and Drug Administration (FDA) approved Accutane in May 1982. Since then, the agency has taken a number of safety-related actions against the acne drug.

1984 – Black Box Warning: The harshest warning the FDA can require, the black box warning cited risks of fetal abnormalities in women who got pregnant while taking Accutane.

2005 – Safety Alert and iPledge: The FDA issued a safety communication recommending observation of patients undergoing isotretinoin therapy for symptoms, including “sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression.” A labeling revision reflecting this recommendation was made in August 2005.

The iPledge program aims to reduce the incidence of pregnancy in female patients taking isotretinoin. iPledge was updated in 2007 and 2010, to include measures such as a patient agreement to using two forms of birth control, monthly pregnancy testing, and prescriber and pharmacist certification.

2007 – FDA Warning: The FDA issued a significant warning against the online purchase of Isotretinoin under any brand name.

Accutane Side Effects

Accutane can cause a variety of possible side effects. During the first weeks of treatment, about one in five patients experience an acne flare up, but this will clear up over time. In most cases, Accutane treatment takes about four to six months to completely cure acne, though some patients need to take the drug for another four to six months for it to be effective.

Common Accutane Side Effects

  • Dry skin
  • Dry eyes
  • Peeling skin
  • Chapped or dry lips
  • Cheilitis (inflamed lips)
  • Nosebleeds
  • Skin rash
  • Conjunctivitis (pink eye)
  • Fever
  • Pruritus (itchy skin)
  • Blisters and sores on the face, arms, legs, and inside the mouth and throat
  • Hair loss

Patients who are allergic to Accutane may develop hives, swelling of the mouth or face, and bruises and red spots on the legs. Contact your doctor if you have an allergic reaction or suspect you might be allergic to isotretinoin.

Serious Accutane Side Effects

Taking isotretinoin can lead to some very serious side effects. Some of the most commonly reported complications include gastrointestinal conditions, such as inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colities. Doctors often run periodic blood tests on patients during their treatment to monitor their health and test for adverse effects.

Accutane can negatively affect the brain by heightening the pressure placed on it. In extreme cases, this can lead to permanent blindness and even death.

Other side effects caused by pressure on the brain include:

  • Bad headaches
  • Blurred vision
  • Loss of night vision
  • Dizziness
  • Vomiting or nausea
  • Seizures
  • Strokes

Accutane has been known to cause damage to the internal organs (liver, bowel, pancreas, and esophagus), which can result in stomach issues that may be permanent. Symptoms to watch for include:

  • Severe pain in the stomach, bowels, or chest
  • Difficult or painful swallowing
  • Heartburn
  • Diarrhea
  • Dark urine
  • Rectal bleeding
  • Yellowing of the eyes and skin (jaundice)

Accutane can also damage the bones and muscles, causing joint pain and muscle weakness. In other cases, it may cause ringing in the ears or hearing loss, which can be permanent. Accutane sometimes negatively affects night-time vision, but in most cases, this will resolve after you stop taking the drug.

Accutane may increase the cholesterol and fat in the blood, although these issues usually resolve themselves after treatment is finished. Blood sugar problems may also occur, including diabetes. Accutane use may decrease the number of white and red blood cells in the body, and may cause faintness, weakness, or excessive thirst.

Accutane can also cause mental health conditions, including psychosis, depression, and suicidal thoughts.

If you experience any severe symptoms while taking Accutane, stop taking the medication and seek medical assistance immediately.

Accutane, Pregnancy and Birth Defects

The CDC does not recommend Accutane for women who are pregnant or trying to become pregnant. The drug has been linked to a higher risk of miscarriage and serious birth defects, including deformities of the face, skull, brain, and heart.

Due to these risks, women are recommended to take pregnancy tests on a monthly basis while taking Accutane. It is also recommended to use at least two different types of birth control while taking the drug, starting one month before treatment and continuing for at least a month after.

If you become pregnant while on Accutane, stop taking the drug immediately and contact your doctor.

Who Should Take Accutane?

For some acne patients, Accutane treatment poses serious risks. Pregnant women, women trying to become pregnant, or breastfeeding should not use Accutane. If you are allergic to any of the ingredients in the drug, you should not use it.

For children and teenagers, Accutane should be a last resort. If your child has nodular acne and has tried a variety of other treatments with little or no success, then Accutane may be the best option. Speak to your child’s doctor before they begin taking Accutane, and monitor them closely for adverse effects. If a teenager is still growing, Accutane may stunt bone growth.

While taking Accutane and for a minimum of six months after treatment has ended, you should avoid donating blood and having any cosmetic procedures done, including waxing or laser surgery. You should also avoid ultraviolet light, tanning beds, and sunlight while taking the drug.

Before taking Accutane, inform your doctor of any health conditions that you or a member of your family experiences. This includes mental health problems, anorexia, allergies to food or medications, diabetes, asthma, osteoporosis, heart disease, and liver disease.

You should also inform your doctor of any medications you currently take, including dietary supplements, prescription and over-the-counter drugs, and vitamins, particularly Vitamin A. Unless your doctor says otherwise, Accutane should not be taken with Dilantin, Corticosteroid medicines, and St. John’s Wort. Tell your doctor before starting any new medication while taking Accutane.

Accutane Lawsuits

Accutane’s severe side effects have been the subject of several lawsuits. In January 2017, a patient who developed Crohn’s disease after using Accutane for only four months sued Hoffman LaRoche, a Swiss drug-making company that previously sold Accutane to patients in the U.S. Hoffman LaRoche was accused of not adequately warning patients of the risk of developing Crohn’s disease while taking the drug.

In this case, the New Jersey Supreme Court awarded the claimant $25 million. At the time, approximately 3,600 Accutane lawsuits were pending against the drug manufacturer in the state of New Jersey.