Approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of severe, recalcitrant nodular acne when other treatments proved ineffective, Accutane, generic name isotretinion, works by shrinking the sebaceous gland. By shrinking this gland, oil production in the dermis is reduced; less oil production results in less clogging of pores and fewer breakouts. Manufactured by the New Jersey-based pharmaceutical company Hoffman-LaRoche (Roche), Accutane was voluntarily removed from the market in June 2009.  Roche claims to have withdrawn this product because of market share loses, but, at the time of its removal, Roche was inundated with personal injury lawsuits by those alleging Roche failed to give sufficient warning to users regarding the serious and life-threatening side effects of Accutane use.

The FDA has published the following in order to inform people as to the possible risks associated with taking Accutane.  The full Accutane Medications Guide, revised in 2010, was produced by Roche in 2000 and can be found at www.fda.gov/downloads/drugs/drugsafety/ucm085812.pdf.

According to the Accutane Medications Guide, Accutane can cause the following:

* Birth defects, miscarriage, death of the baby, and premature births

* Serious mental health problems.

* Serious brain problems by increasing the pressure in your brain. This can lead to permanent loss of eyesight and, 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

•      seizures (convulsions)

•      stroke

 * Skin problems. Skin rash can occur and in some patients a rash can be serious. Stop using Accutane and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like “pink eye”), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.

 * Stomach 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

•       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 hard physical activity during treatment with Accutane. Tell your doctor if you get:

•       back pain

•       joint pain

•       broken bone

Hearing problems. Stop using Accutane and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.

Vision problems. Accutane may affect your ability to see in the dark. 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 doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Accutane and after treatment.

More common, less serious side effects of Accutane including

  • dry skin
  • chapped lips
  • dry eyes
  • dry nose that may lead to nosebleeds

Have You Been Affected by Accutane?

Any individual or the relative of an individual who has suffered due to Accutane’s side effects is permitted to file a lawsuit. The lawyers can help you determine whether you are qualified to seek compensation.  You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered). If you need further information about the harmful side effects of Accutane or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.