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Accutane Lawsuit

If you have suffered a personal injury as a result of the dangerous drug Accutane, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation and dangerous drug litigation against pharmaceutical companies.

Accutane Capsules (isotretinoin)

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 prescriber how bad your acne is, the possible benefits of Accutane, and its possible side effects, to decide if Accutane is right for you. Your prescriber 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.

1. 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.

2. Mental problems and suicide.

Some patients, while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems.

What are the signs of 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.

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 and personal injury 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 doctor 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 doctor. 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 doctor 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 doctor 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

If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your period, stop using Accutane and call your doctor right away.

What are the signs of mental problems?

Tell your doctor 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 doctor 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 activities you once enjoyed
• Sleep too much or have trouble sleeping
• Become more irritable than usual
• Have a change in your appetite or body weight
• Have trouble concentrating
• Withdraw from your friends or family
• Feel like you have no energy
• Have feelings of worthlessness or inappropriate guilt
• Start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
  

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 severe 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 doctor 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, anorexia nervosa (an eating disorder where people eat too little), or any other important health problems. Tell your doctor about any food or drug allergies you have had in the past. These problems do not necessarily mean you cannot take Accutane, but your doctor needs this information to discuss if Accutane is right for you.
  

How should I take Accutane?

• Tell your doctor 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, anorexia nervosa (an eating disorder where people eat too little), or any other important health problems. Tell your doctor about any food or drug allergies you have had in the past. These problems do not necessarily mean you cannot take Accutane, but your doctor needs this information to discuss if Accutane is right for you.
  How should I take Accutane?
• You will get no more than a 30-day supply of Accutane at a time, to be sure you check in with your doctor each month to discuss side effects.
• Your prescription should have a special yellow self-adhesive sticker attached to it. The sticker is YELLOW. If your prescription does not have this yellow self-adhesive sticker, call your doctor. The pharmacy should not fill your prescription unless it has the yellow self-adhesive sticker.
• 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 a meal, unless your doctor tells you otherwise. Swallow your Accutane capsules with a full glass of liquid. This will help prevent the medication inside the capsule from irritating the lining of your esophagus (connection between mouth and stomach). For the same reason, do not chew or suck on the capsule.
• If you miss a dose, just skip that dose. Do not take 2 doses the next time.
• You should return to your doctor 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 (monthly visits for female patients should always include a urine or serum pregnancy test).
  

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 prescriber 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 do not contain estrogen ("minipills"). They may not work while you take Accutane. Ask your prescriber or pharmacist if you are not sure what type you are using.
• Talk with your doctor if you plan to take other drugs or herbal products. This is especially important for patients using birth control pills and other hormonal types of birth control because the birth control may not work as effectively if you are taking certain drugs or herbal products. You should not take the herbal supplement St. John's Wort because this herbal supplement may make birth control pills not work as effectively.
• Talk with your doctor if you are currently taking an oral or injected corticosteroid or anticonvulsant (seizure) medication prior to using Accutane. These drugs may weaken your bones.
• Do not share Accutane with other people. It can cause birth defects and other serious health problems.
• Do not take Accutane with antibiotics unless you talk to your doctor. 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?

When taking Accutane serious side effects are possible:

• 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 doctor 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, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. 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, or dark urine.
• Bone and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan vigorous physical activity during treatment with Accutane. Tell your doctor if you develop pain, particularly back pain or joint pain. There are reports that some patients have had stunted growth after taking Accutane for acne as directed. There are also some reports of broken bones or reduced healing of broken bones after taking Accutane for acne as directed. No one knows if taking Accutane for acne will affect your bones. If you have a broken bone, tell your doctor that you are taking Accutane. Muscle weakness with or without pain can be a sign of serious muscle damage. If this happens, stop taking Accutane and call your doctor right away.
• 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 doctor 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 prescriber 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 prescriber 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 doctor 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 doctor 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 these symptoms, stop taking Accutane and call your doctor . 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 doctor.