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Accutane ®

Isotretinoin (active ingredients)
Accutane (brand name) - a retinoid (vitamin A derivative).

Isotretinoin is marketed under these names:

  • Accutane
  • Amnesteem
  • Claravis
  • Sotret

Isotretinoin is used to treat the most severe form of acne - nodular acne - that cannot be cleared up by any other acne treatments, including antibiotics. Isotretinoin is highly effective, helps prevent scarring, prolonged remission of acne in up to 85 percent of people, and has the potential to clear severe acne permanently.

Isotretinoin reduces the size of the oil glands so that much less oil is produced. As a result, the growth of bacteria is decreased.

Who Should Not Take Isotretinoin?

  • Pregnant women, women who plan to become pregnant, or become pregnant during isotretinoin treatment. If you get pregnant while taking isotretinoin, stop taking it right away and call your doctor.
  • Women who are breast-feeding.
  • People who are allergic to anything in isotretinoin. Isotretinoin contains parabens, which are used as preservatives in the gelatin capsule.

Tell your healthcare professional if you or someone in your family has had any kind of mental problems, asthma, liver disease, diabetes, heart disease, osteoporosis (bone loss), weak bones, an eating problem called anorexia nervosa (where people eat too little), or any food or medicine allergies.

Registered and Qualified in the iPLEDGE Program

Only people who are registered and activated by their doctors in the iPLEDGE program will be able to get isotretinoin, because isotretinoin can cause serious side effects. You must understand and agree to follow all the instructions in the iPLEDGE program, and sign the patient information - informed consent form. The iPLEDGE program is to make sure females do not become pregnant while taking this medicine. For details of iPLEDGE go to www.fda.gov


Isotretinoin Treatment

Isotretinoin is an oral drug (taken by mouth) that is usually taken once or twice a day with food. One course of isotretinoin treatment usually lasts five months. Isotretinoin may not work for everyone, and some people need more than one course of treatment.

Side Effects and Risks of Isotretinoin

1) Severe Harm to a Fetus

Isotretinoin can cause birth defects in the developing fetus of a pregnant woman. It is important that women of childbearing age are not pregnant and do not get pregnant while taking this medicine. You should ask your doctor when it is safe to get pregnant after you have stopped taking isotretinoin. Isotretinoin can cause:

  • Birth defects (deformed babies)
  • Loss of baby before birth (miscarriage)
  • Death of baby
  • Early (premature) births

Women must not get pregnant. Women must use two separate effective forms of birth control at the same time for:

  • One month before starting isotretinoin
  • During the entire course of treatment
  • One month after stopping isotretinoin

If you have sex anytime without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using isotretinoin and call your doctor right away.

2) Serious Mental Health Problems

Some people with acne become depressed by the changes in the appearance of their skin. Changes in mood may be intensified during treatment or soon after completing a course of medicines like isotretinoin. There have been a number of reported suicides and suicide attempts in people taking isotretinoin. The connection between isotretinoin and suicide or depression is not known. If you or someone you know feels unusually sad or has other symptoms of depression, such as loss of appetite, loss of interest in once-loved activities, or trouble concentrating, it's important to consult your doctor. Isotretinoin may cause:

  • Depression
  • Psychosis (seeing or hearing things that are not real)
  • Suicidal thoughts or actions
  • Aggressive and violent behavior
    • Stop taking isotretinoin and call your doctor right away if you:
      • 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
      • Have a change in your appetite or body weight
      • Withdraw from your family or friends
      • Feel like you have no energy
      • Have feelings of worthlessness or wrong 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
      • School or work performance going down, or trouble concentrating
      • Mood disturbance

3) Serious Brain Problems

Isotretinoin may increase the pressure in your brain, possibly leading to permanent loss of eyesight, or in rare cases, death. Stop taking isotretinoin and call your doctor right away if you get any signs of increased brain pressure such as:

  • Bad headaches
  • Blurred vision
  • Dizziness
  • Nausea or vomiting
  • Seizures (convulsions)
  • Stroke

4) Stomach Area (abdomen) Problems

Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). Stop taking isotretinoin 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

5) Bone and Muscle Problems

Tell your doctor if you plan any vigorous physical activity during treatment with isotretinoin. Tell your doctor if you get:

  • Muscle weakness
  • Back pain
  • Joint pain
  • Broken bone

6) Hearing Problems

  • Stop taking isotretinoin and call your doctor if your hearing gets worse or if you have ringing in the ears.

7) Vision Problems

  • Isotretinoin may affect your ability to see in the dark. Stop taking isotretinoin 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 isotretinoin and after treatment.

8) Lipid (fats and cholesterol in blood) Problems

  • Isotretinoin can raise the level of fats and cholesterol in your blood

9) Allergic Reactions

  • Stop taking isotretinoin and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking isotretinoin and call your doctor if you get a fever, rash, or red patches or bruises on your legs.

10) Blood Sugar Problems

  • Tell your doctor if you are very thirsty or urinate a lot.

11) Decreased Red and White Blood Cells

  • Call your doctor if you have trouble breathing, faint, or feel weak.

Less Serious Side Effects of Isotretinoin

  • Dry eyes, mouth, lips, nose, or skin (very common)
  • Itching
  • Nose bleeds
  • Sensitivity to the sun

Drug Interactions With Isotretinoin

Tell your healthcare professional if you take:

  • Progestin-only containing birth control pills (minipills)
  • Vitamin A supplements
  • Tetracycline medicines
  • Dilantin (phenytoin)
  • Corticosteroid medicines
  • St. John's Wort

Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Isotretinoin and other medicines may affect each other sometimes causing serious side effects.

More Things to Know

  • Do not give blood while you take isotretinoin and for 1 month after stopping isotretinoin. If someone who is pregnant gets your donated blood, her baby may be exposed to isotretinoin and may be born with birth defects.
  • Do not drive at night until you know if isotretinoin has affected your vision. Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using isotretinoin and for at least 6 months after you stop. Isotretinoin can increase your chance of scarring from these procedures.
  • Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights.
  • Do not share isotretinoin with other patients. It can cause serious birth defects and other serious health problems.
  • You will only be able to get up to a 30 day supply of isotretinoin at one time. Refills will require you to get a new prescription from your doctor. The prescription must be filled within 7 days of your office visit.
  • You should receive an isotretinoin medication guide each time you receive isotretinoin. This is required by law.

FDA Approved Accutane in 1982.

FDA Warns Against Buying Accutane and Its Generics Online


Questions? Call Drug Information at 1-888-INFO-FDA (automated) or 301-827-4570
Email: Druginfo@cder.fda.gov

References:
FDA (U.S. Food and Drug Administration)
Center for Drug Evaluation and Research
November 2005
www.fda.gov/

This summary does not include everything there is to know about the medicine mentioned above. Do not use this medicine without first talking to your doctor. Other brand names or generic forms of this medicine may also be available. Side effects other than those listed above may occur. This medicine may be prescribed for other uses. If you have questions or concerns, or want more information, your doctor or pharmacist has the complete prescribing information about this medicine and possible drug interactions.