What is being done about Accutane injuries?
A Congressional hearing about Accutane began in 2002. This hearing raised the level of awareness of Accutane injurues. The FDA has revised the label for Accutane. The revised label includes stronger language about the risk of Accutane injuries and psychiatric problems associated with the drug.
Lawsuits for Accutane injuries have already been filed against Hoffmann-LaRoche in several states. The family of Charles Bishop, the 15-year-old who crashed a small airplane into a building in Florida, has filed suit. Another Accutane injury suit has been filed by the family of 14-year-old Steven Wertheimer, who killed himself by standing in front of a 750,000-ton commuter train traveling northward beside the Palo Alto High School football field. The family of a 22-year-old Virginia man who committed suicide is also suing Hoffman-LaRoche. More suits have also been filed or are pending for Accutane injuries.
What is Accutane?
Accutane, also known as Isotretinoin, is used in the treatment of acne with treatment lasting approximately five months. The treatment leads to clearing of acne for one year or more after the medicine is stopped. Most other acne-controlling medicines are effective only if the medicine is used daily.
What are Accutane side effects?
Unfurtunately, there are Side Effects from using Accutane. Thus, all acne patients don't take isotretinoin. The side effects of Accutane include: Chapped lips 90%, Dry skin and itching 80% - the use of daily alpha hydroxacids will help prevent this side effect, Dryness of nose, mild nosebleed 80%, Irritation of the eyelids and eyes 40% - Vitamin E 400 IU each day may lessen this side effect,
Joint and muscle pains 15%, Temporary hair thinning 10%, Rash 7% , Intestinal symptoms 5%, Urinary symptoms 5%, Headache 5%, Increased sensitivity to sunburn 5%, Decreased night vision less than 1%
Depression, thoughts of suicide less then 1%.
Accutane can also increase the level of blood fats, sometimes to risky levels. Occasionally it may affect the liver. That's why regular blood tests are necessary when you are taking isotretinoin; these tests must be done when you have fasted for 12 hours (no breakfast), so that the blood fat determinations are reliable. A baseline blood chemistry test is established before patients start isotretinoin.
Accutane and Birth Defects
Birth defects. Accutane can cause birth defects (deformed babies) if taken by a pregnant woman. It can also cause miscarriage (losing the baby before birth), premature (early) birth, or death of the baby. Do not take Accutane if you are pregnant or plan to become pregnant while you are taking Accutane. Do not get pregnant for 1 month after you stop taking Accutane. Also, if you get pregnant while taking Accutane, stop taking it right away and call your prescriber. The most damaging side effect of isotretinoin is serious birth defects if taken during pregnancy.
It is critically important for women not to take isotretinoin while pregnant, and not to become pregnant while taking it. Women who are, or expect to be, sexually active while taking isotretinoin must use an effective method of birth control. This usually means oral contraceptive pills and one other additional method of birth control such as a condoms for the male partner. A woman who does get pregnant while on isotretinoin must be prepared to have an abortion and must state this in writing before many physicians will prescribe isotretinoin for her.
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 miscarriage and premature births.
Female patients will not get their first prescription for Accutane unless there is proof they have had 2 negative pregnancy tests. The first test must be done when your prescriber decides to prescribe Accutane. The second pregnancy test must be done during the first 5 days of the menstrual period right before starting Accutane therapy, or as instructed by your prescriber. Each month of treatment, you must have a negative result from a urine or serum pregnancy test. Female patients cannot get another prescription for Accutane unless there is proof that they have had a negative pregnancy test.
A yellow self-adhesive Accutane Qualification Sticker on your prescription indicates to the pharmacist that you are qualified by your prescriber to get Accutane.
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 prescriber or go for a free visit to discuss birth control with another physician or family planning expert. Your prescriber can arrange this free visit, which will be paid for by the manufacturer.
You must use 2 separate forms of effective birth control because any method, including birth control pills and sterilization, can fail. There are only 2 reasons you would not need to use 2 separate methods of effective birth control:
You have had your womb removed by surgery (a hysterectomy).
You are absolutely certain you will not have genital-to-genital sexual contact with a male before, during, and for 1 month after Accutane treatment.
A women who has taken Accutane should not get pregnant until one month after stopping the medication. After that time, it's safe to become pregnant. Because the birth defects caused by isotretinoin are so serious, it's important not to share the pills with others.
We don't know whether isotretinoin taken by men can cause birth defects, so it's best not to get a woman pregnant while taking isotretinoin. If she is not using birth control, the man should use a condom.
There are a few reports of patients having decreased night vision after using Accutane. One patient still had problems six months after the drug was stopped. If you experience trouble with your vision while on Accutane, call the office right away.
Some people develop headaches while on Accutane. If you develop a persistent headache while on Accutane, call your physician right away. A persistent headache, which will not go away while on Accutane, can be dangerous and you should stop the medication.
Accutane and Suicide
Mental problems and suicide. Some patients, while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems. Symptoms of these problems include sad, "anxious" or empty mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. 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. Accutane rarely causes depression and thoughts of suicide. If this were to occur stop the medicine immediately and call your physician.