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Accutane Side Effects | Legal Information
Accutane Lawyer
Hearing & Vision Impairment
Under Federal Law, the manufacturer of a drug is required to revise its label to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.
The FDA has required Hoffmann-La Roche to change their label for Accutane many times. The most recent label states - Hearing Impairment: Impaired hearing has been reported in patients taking Accutane; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanisms(s) and causality for this event has not been established. Patients who experience tinnitus or hearing impairment should discontinue Accutane treatment and be referred for specialized care for further evaluation.
Vision Impairment: Visual problems should be carefully monitored. All Accutane patients experiencing visual difficulties should discontinue Accutane treatment and have an ophthalmological examination.
Corneal Opacities: Corneal opacities have incurred in patients receiving Accutane for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization. The corneal opacities that have been observed in clinical trial patients treated with Accutane have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug.
Decreased Night Vision: Decreased night vision has been reported during Accutane therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problems and warned to be cautious when driving or operating any vehicle at night.
Pursuant to FDA Rules and Regulation, the reporting of Adverse Side Effects is on a voluntary basis. In other words, the doctor, hospital, or other medical person or facility are not required by law to report an adverse side effect from a drug. The FDA reported that perhaps only one in one hundred side effects ever get reported. One could only imagine about how many serious Adverse Side Effects there are from taking Accutane, that have never been reported to anyone!
For information regarding Hearing and Vision Impairments, please visit.
Hearing
Vision
FDA - Accutane Information Page
If you believe you have been injured or have suffered a severe side effect from the use of Accutane, it may be that you are entitled to compensation.
It is important that if you contact our firm for a free case evaluation. Our lawyers will analyze your case and advise whether you are entitled to compensation. Contact us here
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