Accutane Info

Information on the development, history and infamy of Accutane.
Accutane Info: Why Use Accutane? Accutane Regulations Before Using Medicine Accutane History: Accutane's Historical Timeline Side Effects: Accutane Side Effects Common Side Effects Potential Side Effects Serious Accutane Side Effects Lawsuits: Lawsuits against La Roche Pregnancy: Accutane and Pregnancy Guidelines for Females Overview: Overview of Accutane Labelling: Accutane Warning Labels iPledge: New Accutane Registration Requirements Contraindictions and Warnings Accutane Blog

Accutane Side Effects

In the twenty years since accutane's release it has been linked to numerous life threatening side effects. It has been the subject of many court cases and even a United States congressional hearing.

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Such is the controversy surroundinng accutane that a number of goverment backed innitiatives have been launced over the years to protect consumers from its potentially devastaing effects. Currently the FDA requires that any potential user signs a consent from stating that they are fully aware of the risks related to the drug. In 2005 the FDA increased their regulations to include a national register in the USA that every patient using accutane must be enrolled on.

In Janunary 2006 the FDA officially launched the iPLEDGE program. This is an electronic database containinng informaion on every patient prescribed accutane in the USA. Their mission is to stop pregnancy occuring during accutane treatment and to stirictly regulate and monitor the use of the drug.

Pharmacists must also give users a detailed warning brochure from the FDA called a Medguide. Throughout the history of the United States FDA (Food and Drug Administration) only three drugs have been required to come with a Medguide: Accutane, Thalidomide and Mifeprex (mifepristone).

Common Side Effects

Side effects from isotretinoin are common.Tell your doctor if any of these symptoms are severe or do not go away:

  • red, cracked, and sore lips
  • red, itchy, dry, and inflamed eyes
  • dry mouth and nose
  • dry skin
  • thinning of the hair
  • fatigue

Potential Side Effects

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

Serious Accutane Side Effects

The following warning regarding the potential serious side effects of accutane appear on the FDA's website.

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.

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.
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."

Psychiatric Diseases, Depression 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."

Central Nervous System Ailments

"[Accutane can cause] serious 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 prescriber right away if you get any of these signs of increased pressure: bad headache, blurred vision, dizziness, nausea, or vomiting. Also, some patients taking Accutane have had seizures (convulsions) or strokes."

Liver Damage

"Symptoms [of Accutane usage] 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."

Hearing/Vision Problems

"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 prescriber 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."

Accutane Pancreatic Damage

"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."

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