It was anecdotal reports linking psychiatric problems with Accutane use that prompted the Food and Drug Administration to pressure the drug's manufacturer, Roche Pharmaceuticals, of Nutley, N.J., to issue new warning labels about how it is prescribed.

Roche has sent dermatologists, family physicians, psychiatrists and pharmacists material informing them that patients who agree to take Accutane must get a medication guide and sign what is called an "informed consent form."

Both address mental disorder side effects, saying "Some patients while taking Accutane or soon after stopping Accutane have become depressed or developed other serious mental problems."

The drug, which is taken by approximately 500,000 Americans each year, is essentially the only treatment for severe or nodular acne. The condition affects mainly young men but also women in the 20s, 30s and 40s. Sufferers often experience scarring. While many people do not experience the mood changes on the medication, enough cases of psychiatric reactions drew the FDA's attention.

Despite the new warnings, Roche maintains there is no scientific evidence of a link between Accutane and depression or suicide. A Roche spokesperson says there is a "high incidence of depression and suicide among boys who may not go to a doctor." These new consent forms are making "parents and physicians pay more attention to such problems."

"How can a drug company receive such a stern warning from the FDA to change their warning label and not recall all of the outstanding inventory in all of the pharmacies and make that change immediately. Why has it taken so long to make the changes to their warning label. Their slow response and denial of the need for the new warning makes you suspicious of what are they trying to hide that we don't know about."
Charles H. Jackson, Jr. Lubbock, Texas

Informed Consent Lists Possible Psychiatric Problems

On the informed consent document, patients must acknowledge they are aware of the potential mental health side effects and agree to tell their physician if they start experiencing them. They also must tell their doctor if they or any member of their family has had mental illness.

The medication guide tells patients about Accutane's use and its potential side effects, including birth defects and mental disorders.

Doctors say the new policy is a responsible way to address the growing concerns.

INFORMED CONSENT/ PATIENT AGREEMENT

To be completed by the patient, parent, or guardian
and signed by the health care provider

Read each item below and initial in the space provided if you understand each item and agree to follow your health care provider's (provider) instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement.

Do not sign this agreement and do not take Accutane if there is anything that you do not understand about all the information you have gotten about using Accutane.

1. I, ___________________________________________________________________,

(Patient's Name)

understand that Accutane is a medicine used to treat severe 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. If untreated, severe nodular acne can lead to permanent scars.

Initials: ________

2. My provider has told me about my choices for treating my acne.

Initials: ________

3. I understand that there are serious side effects that may happen while I am taking Accutane. These have been explained to me. These side effects include serious birth defects in babies of pregnant females (Note: There is a second Informed Consent form for female patients concerning birth defects.)

Initials: ________

4. I understand that 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. Some people have had other signs of depression while taking Accutane (see #7 below).

Initials: _________

Before I start taking Accutane, I agree to tell my health care provider if, to the best of my knowledge, I have ever had symptoms of depression (see #7 below), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.

Initials: ___________

Before I start taking Accutane, I agree to tell my health care provider if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.

Initials: ___________

Once I start taking Accutane, I agree to stop using Accutane and tell my provider right away if any of the following happen. I:

* start to feel sad or have crying spells
* lose interest in my usual activities
* have changes in my normal sleep patterns
* become more irritable than usual
* lose my appetite
* become unusually tired
* have trouble concentrating
* withdraw from family and friends
* start having thoughts about hurting yourself/myself or taking your/my own life (suicidal thoughts)

 

Initials: _________

* I agree to return to see my provider every month I take Accutane to get a new prescription for Accutane, to check my progress, and to check for signs of side effects.

Initials: ___________

9. Accutane will be prescribed just for me-I will not share Accutane with other people because it may cause serious side effects, including birth defects.

Initials: _________

10. I will not give blood while taking Accutane or for 1 month after I stop taking Accutane. I understand that if someone who is pregnant gets my donated blood, her baby may be exposed to Accutane and may be born with serious birth defects.

Initials: _________

11 . I have read the brochure Important Information Concerning Your Treatment with Accutane and other materials my provider gave me containing important safety information about Accutane. I understand all the information I received.

Initials: _________

12. My provider and I have decided I should take Accutane. I understand that I can stop taking Accutane at any time. I agree to tell my provider if I stop taking Accutane.

Initials:_______

 

I now authorize my prescriber ________________________ to begin my treatment with Accutane.

Patient signature _____________________________

Date_________________

Parent/guardian signature (if under age 18): ________________________________

Date: ____________________

Patient Name (print) __________________________

Patient Address_______________________________________________

____________________________ Telephone (_____-_____-_____)

I have

fully explained to the patient, _________________, the nature and purpose of Accutane treatment, including its benefits and risks

given the patient the brochure for Accutane and asked the patient if he/she has any questions regarding his/her treatment with Accutane

answered those questions to the best of my ability.

Prescriber signature: ___________________________ Date:

 

Medication Guide - 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.

What are the important warnings for females taking Accutane?

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:

* the second day of your next period
* 11 days after you last had sexual intercourse without using birth control

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:

* You have had your uterus removed by surgery (hysterectomy).
* You commit to complete abstinence. This means that you are absolutely positive that you will not have genital-to-genital sexual contact before, during, and for 1 month after Accutane treatment.

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.

 What are the signs of mental problems?

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

* start to feel sad or have crying spells
* lose interest in your usual activities
* have changes in your normal sleep patterns
* become more irritable than usual
* lose your appetite
* become unusually tired
* have trouble concentrating
* withdraw from family and friends
* start having thoughts about hurting yourself/myself or taking your/my own life (suicidal thoughts)

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?

* Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes birth defects. All females should read the section "What are the important warnings for females taking Accutane?" for more information and warnings about Accutane and pregnancy.
* Do not take Accutane unless you completely understand its possible risks and are willing to follow all of the instructions in this Medication Guide.

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?

* You will get a 1 month supply of Accutane at a time, to be sure you check in with your provider each month to discuss side effects.
* The amount of Accutane you take has been specially chosen for you and may change during treatment.
* You will take Accutane 2 times a day with food, unless your provider tells you otherwise.
* If you miss a dose, just skip that dose. Do not take 2 doses the next time.
* You should return to your provider as directed to make sure you don't have signs of serious side effects. Because some of Accutane's serious side effects show up in blood tests, some of these visits may involve blood tests.

What should I avoid while taking Accutane?

* Do not get pregnant while taking Accutane. See "What is the most important information I should know about Accutane?" and "What are the important warnings for females taking 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 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.
* 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 provider 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.
* Do not use birth control pills that have a low dose of progesterone (minipills). They may not work while you take Accutane.

* Do not share Accutane with other people. It can cause birth defects and other serious health problems.
* Do not take antibiotics with Accutane unless you talk to your provider. For some antibiotics, you may have to stop taking Accutane until the antibiotic treatment is finished. Use of both drugs together can increase the chances of getting increased pressure in the brain.

What are the possible side effects of Accutane?

Accutane has possible serious side effects

* Accutane can cause birth defects, premature births, and death in babies whose mothers took Accutane while they were pregnant. See "What is the most important information I should know about Accutane?" and "What are the important warnings for females taking Accutane?"
* Serious mental health problems. See "What is the most important information I should know about Accutane?"
* Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of sight, or in rare cases, death. Stop taking Accutane and call your provider right away if you get any of these signs of increased brain pressure: bad headache, blurred vision, dizziness, nausea, or vomiting. Also, some patients taking Accutane have had seizures (convulsions) or stroke.
* Abdomen (stomach area) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, and bowel (intestines). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your provider if you get severe stomach or bowel pain, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine.
* Bone and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your provider if you plan vigorous physical activity during treatment with Accutane. Tell your provider if you develop pain. If a bone breaks, tell your provider you take Accutane. No one knows if taking Accutane for acne will reduce bone healing or stunt growth.
* Hearing problems. Some people taking Accutane have developed hearing problems. It is possible that hearing loss can be permanent. Stop using Accutane and call your provider if your hearing gets worse or if you have ringing in your ears.
* Vision problems. While taking Accutane you may develop a sudden inability to see in the dark, so driving at night can be dangerous. 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 provider right away if you have any problems with your vision or dryness of the eyes that is painful or constant.
* Lipid (fats and cholesterol in blood) problems. Many people taking Accutane develop high levels of cholesterol and other fats in their blood. This can be a serious problem. Return to your provider for blood tests to check your lipids and to get any needed treatment. These problems generally go away when Accutane treatment is finished.
* Allergic reactions. In some people, Accutane can cause serious 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 provider if you develop a fever, rash, or red patches or bruises on your legs.
* Signs of other possibly serious problems. Accutane may cause other problems. Tell your provider if you have trouble breathing (shortness of breath), are fainting, are very thirsty or urinate a lot, feel weak, have leg swelling, convulsions, slurred speech, problems moving, or any other serious or unusual problems. Frequent urination and thirst can be signs of blood sugar problems.

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.

 

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