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Accutane Side Effects | Legal Information
Accutane Lawyer
 Skin Diseases/ Injuries from Accutane
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!
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 revise its label for Accutane many times. The most recent label states - ...Many of the side effects and adverse reactions seen in patients receiving Accutane are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, et, of the lips, nasal passage, and eyes.
Skin and Appendages: acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), sunburn susceptibility increased, sweating, urticaria, vasculitis (including Wegener's granulomatosis: see PRECAUTIONS: Hypersensitivity), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see PRECAUTIONS: Information for Patients and Prescribers)
FDA - Accutane Information Page
Hoffmann-La Roche down-plays the side effects of Accutane by talking about its effect on the skin. They readily admit that it causes skin diseases and/or injuries. Following are just a few of those skin and appendages side effects.
Acne Fulminans
Acne fulminans is a rare and very severe form of acne conglobata associated with systemic symptoms. It nearly always affects males. It is characterized by:
- Abrupt onset
- Inflammatory and ulcerated nodular acne on chest and back
- Severe acne scarring
- Fluctuating fever
- Painful joints
- Malaise (i.e. the patient feels unwell)
- Loss of appetite and weight loss
- Raised while blood cell count
One source of additional information is DermNet
Alopecia
(Hair Loss - Sometimes Permanent)
Epistaxis
(Nose Bleeds)
Eruptive Xanthomas
Eruptive xanthomas are yellow-orange-to-red-brown papules that are often surrounded by an erythematous halo. They appear in crops on the buttocks, extensor surfaces of the extremities, and flexural creases. Acutely, variable amounts of pruritus and pain occur. A Koebner reaction may be present. Lesions usually resolve spontaneously over weeks and may result in hypertrophic scars. Histologically, foamy macrophages are present in the dermis with an inflammatory infiltrate of lymphocytes and neutrophils.
Eruptive xanthomas can occur in the setting of chylomicronemia and hypertriglyceridemia. (Hypertriglyceridemia is a frequent side effect of Accutane.) This may be due to a primary hyperlipoproteinemia resulting from a genetic deficiency of lipoprotein lipase (Type 1 hyperlipoproteinemia) or familial hyperlipoproteinemia (Type V). Eruptive xanthomas often also occur secondarily in individuals unresponsive to insulin. Insulin is required for the normal triglyceride clearing function of lipoprotein lipase. Whenever insulin deficiency is present, an acquired lipoprotein lipase deficiency exists, which results in impaired clearance of chylomicrons and very-low-density lipoproteins causing the resultant hypertriglyceridemia. Rarely, eruptive xanthomas have been reported with hypothyroidism, nephrotic syndrome, and von Gierke's glycogen storage disease. They have been noted also after ingestion of alcohol, glucocorticoids, estrogens, and retinoids.
Other features of hyperlipidemia often noted in patients with eruptive xanthomas include lipemia retinalis, hepatosplenomegaly, and abdominal pain. The abdominal pain may be secondary to intestinal ischemia from increased blood viscosity, stretching of organ
Hirsutism
(Increased Hair Growth Even in Women)
Vasculitis Including Wegener's Granulomatosis
Wegener's Granulomatosis (WG) is a rare form of vasculitis; that is, a disease characterized by inflammation of the walls of the blood vessels. This inflammation can result in damage to vital organs of the body by restricting blood flow to those organs. WG normally begins as a localized granulomatous inflammation of the nasal mucosa (lining) and lung tissue, and usually progresses into generalized necrotizing (gradual degeneration) granulomatous (tumor-like) inflammation of the blood vessels. WG is an autoimmune disease, meaning the body's immune system attacks its own body tissue.
Although vasculitic diseases can result in damage to any organ system, WG primarily affects the respiratory tract (sinus, nose, trachea, and lungs) and the kidneys, and may involve the joints, eyes, ears, and skin. Patients who do not have renal (kidney) involvement are described as having Limited Wegener's. This disorder occurs equally in males and females and can occur at any age, but usually in middle age. For more information, please visit, Wegener's Granulomatosis Association
 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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