New Brochure introduced for Prescribers of Accutane in February 2002
Psychiatric Disorders in Adolescents and Young Adults'
The New Medication Guide was introduced by the FDA on the 23rd January 2001, which states 'Read this Medication Guide every time you get a prescription or a refill for Accutane (ACK-you-tane). There may be new information. This information does not take the place of talking with your health care provider (provider)'.
There are only two other prescription medications sold in the Unitied States, apart from Accutane/Roaccutane, which have attracted an FDA medication guide classification.Medication Guide for Accutane Capsules (isotretinoin)
Read this Medication Guide every time you get a prescription or a refill for Accutane (ACK-you-tane). There may be new information. This information does not take the place of talking with your health care provider (provider).
What is the most important information I should know about Accutane?
Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. However, Accutane can cause serious side effects. Before starting Accutane, discuss with your provider how bad your acne is, the possible benefits of Accutane, and its possible side effects, to decide if Accutane is right for you. Your provider will ask you to read and sign a form or forms indicating you understand some of the serious risks of Accutane.
Possible serious side effects of taking Accutane include birth defects and mental disorders
Birth defects. Accutane can cause birth defects (deformed babies) if taken by a pregnant woman. It can also cause miscarriage, premature birth, or death of the baby. Do not take Accutane if you are pregnant or plan to become pregnant while you are taking Accutane, or for 1 month after you stop taking Accutane. Also, if you get pregnant while taking Accutane, stop taking it right away and call your provider.
All females should read the section in this Medication Guide "What are the important warnings for female patients?"
Mental problems and suicide. Some patients, while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems. Signs of these problems include feelings of sadness, irritability, unusual tiredness, trouble concentrating, and loss of appetite. 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. There were reports that some of these people did not appear depressed. No one knows if Accutane caused these behaviors or if they would have happened even if the person did not take Accutane.
All patients should read the section in this Medication Guide "What are the signs of mental problems?"<
For other possible serious side effects of Accutane, see "What are the possible side effects of Accutane?" in this Medication Guide.
You must not become pregnant while taking Accutane, or for 1 month after you stop taking Accutane. Accutane can cause severe birth defects in babies of women who take it while they are pregnant, even if they take Accutane for only a short time. There is an extremely high risk that your baby will be deformed or will die if you are pregnant while taking Accutane. Taking Accutane also increases the chance of losing the baby before it is born (miscarriage) and early (premature) births.
Female patients will not get their first prescription for Accutane unless there is proof from 2 tests that they are not pregnant. One test must be done on one of these 2 dates, whichever is later:
You can get a prescription for Accutane only when the required testing shows you are not pregnant. Female patients cannot get monthly refills for Accutane, unless there is proof that they are not pregnant.
While you are taking Accutane, you must use effective birth control. You must use 2 separate effective forms of birth control at the same time for at least 1 month before starting Accutane, while you take it, and for 1 month after you stop taking it. You can either discuss effective birth control methods with your provider or go for a free visit to discuss birth control with someone else. Your provider can arrange this free visit.
You must use 2 separate forms of effective birth control because any method, including birth control pills and sterilization, can fail. Further, no one knows if Accutane lowers the effectiveness of birth control pills or injections (shots). There are only 2 reasons you would not need to use 2 separate methods of effective birth control:
If you have sex without using effective birth control or miss your period, stop using Accutane and call your provider right away.
All patients should read the rest of this Medication Guide.
Tell your provider if, to the best of your knowledge, you or someone in your family has ever had any mental illness, including depression, suicidal behavior, or psychosis. Psychosis means a loss of contact with reality, such as hearing voices or seeing things that are not there. Also, tell your provider if you take medicines for any of these problems.
Stop using Accutane and tell your provider right away if you
What is Accutane?
Accutane is used to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars. However, because Accutane can have serious side effects, you should talk with your provider about all of the possible treatments for your acne, and whether Accutane’s possible benefits outweigh its possible risks.
Who should not take Accutane?
Tell your provider if you or someone in your family has had any kind of mental problems, asthma, liver disease, diabetes, heart disease, or any other important health problems. Tell your provider about any food or drug allergies you have had in the past. Your provider needs this information to discuss if Accutane is right for you.
How should I take Accutane?
What should I avoid while taking Accutane?
Accutane has possible serious side effects
Serious permanent problems do not happen often. However, because the symptoms listed above may be signs of serious problems, if you get them, stop taking Accutane and call your provider. If not treated, they could lead to serious health problems. Even if these problems are treated, they may not clear up after you stop taking Accutane.
Accutane has less serious possible side effects
The common less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. People who wear contact lenses may have trouble wearing them while taking Accutane and after therapy. Sometimes, people’s acne may get worse for a while. They should continue taking Accutane unless told to stop by their provider.
These are not all of Accutane’s possible side effects. Your provider or pharmacist can give you more detailed information that is written for health care professionals.
This Medication Guide is only a summary of some important information about Accutane. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns or questions about Accutane, ask your provider. Do not use Accutane for a condition for which it was not prescribed.
Active Ingredient: Isotretinoin.
Inactive Ingredients: beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10mg—iron oxide (red) and titanium dioxide; 20 mg—FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg—F&C Yellow No. 6, FD&C Yellow No. 10, and titanium dioxide.
FDA/Center for Drug Evaluation and Research
Last Updated: January 23, 2001
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