Accutane

Accutane (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. Accutane is only for patients who understand and agree to carry out all the instructions in the iPLEDGE program, because Accutane can cause serious side effects.

Accutane should NOT be used by pregnant women. Do not take Accutane if you are:

  • Pregnant, plan to become pregnant, or become pregnant during Accutane treatment
  • Breastfeeding
  • Allergic to anything in it. Accutane contains parabens, which are used as preservatives in the gelatin capsule.

 
Birth defects (deformed babies), loss of baby before birth (miscarriage), death of baby, and early (premature) births. If you get pregnant while taking Accutane, stop taking it right away and call your doctor.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

Serious mental health problems Stop taking Accutane and call your doctor right away if you. Accutane may cause:

  • Depression
  • Psychosis (seeing or hearing things that are not real)
  • Suicidal thoughts or actions
  • Aggressive and violent behavior
  • 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
  • Have trouble concentrating
  • 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 

 
Serious brain problems:

  • Accutane may increase the pressure in your brain, possibly leading to permanent loss of eyesight, or in rare cases, death.
  • Stop taking Accutane 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) or stroke. 

 
 
 

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 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 (jaundice), or dark urine.
Bone and muscle problems:
  • Tell your doctor if you plan any vigorous physical activity during treatment with Accutane. Tell your doctor if you get muscle weakness, back pain, joint pain, or a broken bone.
Hearing problems:
  • Stop taking Accutane and call your doctor if your hearing gets worse or if you have ringing in the ears.
Vision problems:
Accutane may affect your ability to see in the dark. 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.
Lipid (fats and cholesterol in blood) problems
  • Accutane can raise the level of fats and cholesterol in your blood.
Allergic reactions
  • 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.
Blood sugar problems
  • Tell your doctor if you are very thirsty or urinate a lot.
Decreased red and white blood cells
  • Call your doctor if you have trouble breathing, faint, or feel weak.

 
What Should I Do Before Taking Accutane?

  • 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.
  • By March 1, 2006, all patients must be registered and activated by their doctors in iPLEDGE to get Accutane. You must sign the Patient Information/Informed Consent form.
  • You must agree to or follow all the instructions in the iPLEDGE program.
  • By March 1, 2006, only prescriptions from iPLEDGE doctors will be filled by iPLEDGE pharmacies.
  • If you have sex anytime without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using Accutane and call your doctor right away.

 
Females who can become 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 stopping Accutane. You must also call and enter your 2 types of birth control each month into the iPLEDGE system by telephone or the internet.
  • Have negative results from 2 pregnancy tests before receiving the initial Accutane prescription
  • Have a negative pregnancy test before each refill
  • Sign an additional Patient Information/Consent form that contains warnings about the risk of potential birth defects if the fetus is exposed to Accutane

 
Are There Any Interactions With Drugs Or Foods?

  • Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • Accutane and other medicines may affect each other sometimes causing serious side effects. Especially 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

 
Is There Anything Else I Need to Know?

  • 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 drive at night until you know if Accutane has affected your vision. 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.
  • Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights.
  • Do not share Accutane with other people. 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 Accutane 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 Accutane Medication Guide each time you receive Accutane. This is required by law.

 
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this information when additional information is available: