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Accutane® (isotretinoin)

Manufactured by Hoffman-LaRoche and approved by the FDA in 1982, Accutane, generically known as isotretinoin, is an anti-acne medication that works on the oil glands within the skin, shrinking them and diminishing their production. Accutane is taken by mouth everyday for four to five months and then treatment is stopped. The anti-acne effect produced by Accutane can last a year or more after finishing a course of medication.

Why is Accutane prescribed?

Accutane is a prescription medication used to treat severe, disfiguring acne that has not responded to other treatments such as topical creams and antibiotics. FDA Approved Uses Accutane is approved by the FDA for the treatment of severe recalcitrant nodular acne. Isotretinoin noticeably reduces the production of sebum and shrinks the sebaceous glands. It stabilizes keratinization and prevents comedones from forming.

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What are the FDA approved uses for Accutane?

Accutane is approved by the FDA for the treatment of severe recalcitrant nodular acne. Isotretinoin noticeably reduces the production of sebum and shrinks the sebaceous glands. It stabilizes keratinization and prevents comedones from forming.

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What are the side effects of Accutane?

The most common side effects include, but are not limited to, bone or joint pain, burning, redness, or itching of the eyes, nosebleeds, skin infection or rash, and severe abdominal or stomach pain, back pain, and nausea and vomiting, which are usually associated with Accutane over-dosage. The most severe side effects include the increase of miscarriage and infant deaths, and can cause severe birth defects, such as fetal malformations, mental retardation, heart defects, and facial abnormalities. Further, Accutane has been linked to depression. The FDA has received approximately 100 reports of suicides linked to the use of Accutane, and over 1,000 reports of various psychological problems among those who use the drug.

  • Crohn’s Disease
  • Inflammatory Bowel Disease
  • Ulcerative Colitis

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Accutane warnings and alerts

If you have taken Accutane and have experienced any unusual side effects, you should contact your physician at once–if you begin feeling depressed or suicidal, contact a psychiatric professional immediately. In addition, you can contact an attorney experienced in Accutane product liability litigation to discuss potential legal claims you might have, as you may be entitled to recover compensation for the damages Accutane has caused you. An experienced attorney can recover loss for medical bills, pain and suffering, occupational wages, and other effects of Accutane treatment.

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Accutane drug contradictions

Accutane should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule, or women who are pregnant.

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Accutane FAQs

What should women know about taking Accutane?

Accutane can increase the risk of miscarriage and infant deaths, and can cause severe birth defects, such as fetal malformations, mental retardation, heart defects, and facial abnormalities. It is critical that women do not become pregnant or breastfeed while taking Accutane, or for at least one month after treatment has stopped. In fact, dermatologists usually require proof of two recent negative pregnancy tests prior to issuing a Accutane prescription, and women who do get pregnant may be encouraged by medical professionals to abort the pregnancy due to the severity of infant health risks. Further, it has not been determined whether Accutane taken by men can attribute to fetal defects.

Acne may in fact get worse when starting to use Accutane, so dermatologists typically prescribe other medicines along with Accutane at the beginning of the treatment. Further, Accutane patients should not give blood while taking Accutane, and vitamin A supplements should not be taken, as high doses of vitamin A have many of the same side effects as Accutane and can increase intestinal complications.

Does Accutane cause depression?

Yes. Although labeling information on Accutane has always warned of the serious risk of birth defects associated with taking the drug, as of February 1998, Roche Pharmaceuticals issued a letter to physicians wherein they added the following to the warnings section of prescribing information for Accutane: “Psychiatric disorders: Accutane may cause depression, psychosis, and has been linked to suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events.”

Can I file a lawsuit if I have suffered damages from taking Accutane?

Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

  • Past and future medical expenses
  • Past and future pain and suffering
  • Lost wages
  • Loss of future earning capacity
  • Emotional distress

If you or a loved one has experienced any health problems while taking Accutane, you should contact your doctor immediately. You may also wish to contact an experienced Accutane lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.

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