Accutane Prescription Recommendations, Limitations, Off-Label Uses

J. Cooper Carlisle | March 3rd, 2011 | Posted in Accutane Lawsuit News


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Accutane off-label uses have drastically increased the number of individuals victimized by Accutane side effects. The original FDA approval of Accutane (otherwise known as isotretinoin) was a treatment for severe acne. Hoffman-LaRoche received FDA approval for the drug in 1982. Since that time the drug has become very popular. There have been over one million prescriptions generated.

Accutane off-label uses not worth risking the severe side effects

Severe acne is characterized by swollen red bumps in the skin of the patient that can lead to both potential scarring and actual physical pain. The definition of “severe acne” limits the approved use of the drug strictly to those forms of acne that cannot be treated with any other type of medication. These strict limitations were placed on the drug due to the potential severe side effects. Accutane side effects can be so severe that in 2004 the FDA named Accutane one of the 5 most dangerous prescription drugs available.

Despite the serious nature of the limitations that were originally placed on Accutane, studies indicate that 90% of users do not suffer from severe acne.

Accutane Off-label uses include:

  • Moderate acne
  • Mild acne

Accutane side effects include:

The treatment of Accutane as a general acne medication has drastically increased the number of adverse events due to serious Accutane side effects.