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Accutane (isotretinoin) Information
Accutane Side Effects | Legal Information
Accutane Lawyer
The Accutane Team is only accepting cases involving bowel injuries
 Bone & Muscle Damage
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 June 2002 Label states - ...bone and muscle damage - ...In a separate open-label extension study of 10 patients... ...showed a decrease in mean lumbar spine bone mineral density... ...Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the Accutane population. While causality to Accutane has not been established, an effect cannot be ruled out. Longer term effects have not been studied...
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!
ARTICLES & INFORMATION
January 21, 1983 -
Accutane - Bone Swelling -
Five of seven patients taking Accutane for acne showed symptoms and/or x-ray evidence of swelling of skeletal bones. Frank Yoder, M.D., who has been closely associated with Accutane since the first clinical study, feels that the potential toxicity of this medication has been seriously underemphasized. (Journal of the American Medical Association 294(3)350-351, January 21, 1983)
August 16, 1986 -
Accutane - Muscle Damage -
Accutane (isotretinoin) may cause muscle damage according to a report from Israel. It has been estimated that 15 percent of patients given Accutane develop musculoskeletal symptoms during treatment.
Two young males given Accutane for nodulocystic [sic] acne developed weakness and muscle pain a few days after isotretinoin therapy was begun. They had muscle tenderness to touch. After the medication was discontinued the muscle pain gradually disappeared. Vitamin A toxicity is known to produce muscle stiffness and pain. (British Medical Journal 293:425-6, August 16, 1986)
November 6, 1986 -
Accutane - Tendon and Ligament Calcification -
Accutane (isotretinoin) given to treat acne, produced calcifications of tendons and ligaments in 32 of 38 patients in a study carried out at the National Institutes of Health. The ankles, pelvis and knees were the most common sites of calcification. (New England Journal of Medicine 315(19)1177-82, November 6, 1986)
May 10, 2002 -
New FDA Warning -
WARNING
The Food and Drug Administration (FDA) has approved updated labeling for Accutane, warning of the risk of musculoskeletal adverse events. Patients taking Accutane have reported spontaneous osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures. The new warning states that the link to Accutane has not been established, but that care should be taken and the drug should be used no longer than the recommended duration of therapy.
FDA - Accutane Information Page
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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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