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
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