Accutane

FDA Black Box Warning

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• Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
• Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.
• Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.
• If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

What is the most important information I should know about Accutane?

• Because Accutane can cause serious birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program. Adverse effects in pregnancy include birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Accutane. Female patients must not get pregnant: 

• for 1 month before starting Accutane 
• while taking Accutane 
• for 1 month after stopping Accutane. 

If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

• FDA MedWatch at 1-800-FDA-1088, and 
• the iPLEDGE pregnancy registry at 1-866-495-0654 

2. Accutane may cause serious mental health problems. Accutane may cause:

• depression 
• psychosis (seeing or hearing things that are not real) 
• suicide. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. 

Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis: 

• start to feel sad or have crying spells 
• lose interest in activities you once enjoyed 
• sleep too much or have trouble sleeping 
• become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) 
• have a change in your appetite or body weight 
• have trouble concentrating 
• withdraw from your friends or family 
• feel like you have no energy 
• have feelings of worthlessness or guilt 
• start having thoughts about hurting yourself or taking your own life (suicidal thoughts) 
• start acting on dangerous impulses 
• start seeing or hearing things that are not real 

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms. 

How should I take Accutane?

You will not be prescribed Accutane if you cannot agree to or follow all the instructions of the iPLEDGE program.

You will get no more than a 30-day supply of Accutane at a time. This is to make sure you are following the Accutane iPLEDGE program. You should talk with your doctor each month about side effects. The amount of Accutane you take has been specially chosen for you. It is based on your body weight, and may change during treatment. Take Accutane 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Accutane capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Accutane can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole. If you miss a dose, just skip that dose. Do not take 2 doses at the same time. If you take too much Accutane or overdose, call your doctor or poison control center right away. Your acne may get worse when you first start taking Accutane. This should last only a short while. Talk with your doctor if this is a problem for you. You must return to your doctor as directed to make sure you don't have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Accutane. Female patients who can get pregnant will get a pregnancy test each month. Female patients who can get pregnant must agree to use 2 separate forms of effective birth control at the same time 1 month before, while taking, and for 1 month after taking Accutane. You must access the iPLEDGE system to answer questions about the program requirements and to enter your 2 chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654. You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Accutane. If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using Accutane and call your doctor right away.

What should I tell my doctor before taking Accutane?

Tell your doctor if you or a family member has any of the following health conditions:

• mental problems
• asthma
• liver disease
• diabetes
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little)
• food or medicine allergies

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

• Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain. 
• Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
• Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
• Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
• St. John's Wort. This herbal supplement may make birth control pills work less effectively.

These medicines should not be used with Accutane unless your doctor tells you it is okay. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

What should I avoid while taking Accutane?

• Do not get pregnant while taking Accutane and for 1 month after stopping Accutane. 
• Do not breast feed while taking Accutane and for 1 month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
• Do not give blood while you take Accutane and for 1 month after stopping Accutane. If someone who is pregnant gets your donated blood, her baby may be exposed to Accutane and may be born with birth defects.
• Do not take other medicines or herbal products with Accutane unless you talk to your doctor.
• Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light. You should use sunscreen with SPF 30 or more.
• Do not share Accutane with other people. It can cause birth defects and other serious health problems.

What are the possible side effects of Accutane?

• Accutane can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. 
• Your acne may get worse when you first start taking Accutane. This should last only a short while. Talk with your doctor if this is a problem for you.
• Accutane may cause serious mental health problems.
• serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. 

Stop taking Accutane and call your doctor right away if you get any of these signs of increased brain pressure:

• bad headache
• blurred vision
• dizziness
• nausea or vomiting
• seizures (convulsions)
• stroke
• skin reactions occur in most patients taking Accutane. In some patients a skin reaction can be serious. Stop using Accutane and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like "pink eye"), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
• Accutane has caused damage to organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach) in some patients. If your organs are damaged, they may not get better even after you stop taking Accutane. 

Stop taking Accutane and call your doctor if you get:

• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• diarrhea
• rectal bleeding
• yellowing of your skin or eyes
• dark urine

Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Accutane may stop long bone growth in teenagers who are still growing. Tell your doctor if you plan hard physical activity during treatment with Accutane. Tell your doctor if you get: 

• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take Accutane if you break a bone.
• Stop Accutane and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
• Stop using Accutane and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
• Accutane may affect your ability to see in the dark. This condition usually clears up after you stop taking Accutane, but it may be permanent. Other serious eye effects can occur. Stop taking Accutane and call your doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Accutane and after treatment.
• Accutane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Accutane treatment is finished.
• Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• Accutane may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
• Call your doctor if you have trouble breathing, faint, or feel weak. Accutane can cause blood system problems like anemia
• The common, less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.

Reviewed by:	Review Date:
Joseph V. Madia, MD	Friday, June 17, 2011

Source: FDA