Thread: acne
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Old 06-26-2003, 01:46 PM   #12 (permalink)
digby
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Location: Ahh, the lovely South
Here is a little bit about Accutane

If you want more info, let me know and I'll see what I can dig up. This isn't to discourage you from trying the drug, just to let you know what your doctor doesn't know. Everything that doctors write for is chosen generally by the last drug rep. to visit them... but that's a rant for another thread.



from a website my pharmacy subscribes to (eFactsweb.com):

(note that Isotretinoin is the generic name for accutane)

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Warnings

Psychiatric disorders:
Isotretinoin may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, suicide, and aggressive or violent behavior. Discontinuation of isotretinoin therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events.


Pseudotumor cerebri (benign intracranial hypertension):
Isotretinoin use has been associated with a number of cases of pseudotumor cerebri, some of which involved concomitant use of tetracyclines. Therefore, avoid concomitant treatment with tetracyclines. Early signs and symptoms include papilledema, headache, nausea, vomiting, and visual disturbances. Screen patients with these symptoms for papilledema; if present, discontinue drug immediately and consult a neurologist.


Pancreatitis:
Acute pancreatitis has been reported in patients with elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. Stop isotretinoin if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.


Visual impairment:
Carefully monitor visual problems. If visual difficulties occur, discontinue the drug and have an ophthalmological examination.


Corneal opacities:
These have appeared in patients receiving isotretinoin for acne and more frequently in patients on higher dosages for keratinization disorders. Corneal opacities have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation.


Decreased night vision:
Decreased night vision has occurred during therapy and in some cases persisted after therapy was discontinued. Because the onset in some patients was sudden, advise patients of this potential problem and warn them to be cautious when driving or operating any vehicle at night.


Inflammatory bowel disease:
Inflammatory bowel disease, including regional ileitis, has been associated with isotretinoin in patients without a history of intestinal disorders. In some instances, symptoms have been reported to persist after isotretinoin therapy has been stopped. Discontinue treatment immediately if abdominal pain, rectal bleeding, or severe diarrhea occurs.


Hypertriglyceridemia:
Hypertriglyceridemia in excess of 800mg/dL occurred in approximately 25% of patients; approximately 15% developed a decrease in high density lipoproteins(HDL) and approximately 7% showed an increase in cholesterol levels. Perform blood lipid determinations before isotretinoin is given and then at intervals until the lipid response to isotretinoin is established, which usually occurs within 4 weeks.


These effects are reversible after cessation of therapy. Patients who are at high risk of developing hypertriglyceridemia include those with diabetes, obesity, increased alcohol intake, a lipid metabolism disorder, and a familial history.


Reduction of weight, dietary fat intake, alcohol intake, and dose may reverse the effects on serum triglycerides, allowing patients to continue therapy.


Musculoskeletal effects:
In a clinical trial (N = 217) of a single course of therapy for isotretinoin, 7.9% of patients had decreases in lumbar spine bone mineral density greater than 4%, and 10.6% of patients had decreases in total hip bone mineral density greater than 5%.


Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the isotretinoin population. While causality to isotretinoin has not been established, an effect cannot be ruled out. Physicians should use caution when prescribing isotretinoin to patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. This would include patients diagnosed with anorexia nervosa and those who are on chronic drug therapy that causes drug-induced osteoporosis/osteomalacia and/or affects vitamin D metabolism, such as systemic corticosteroids and any anticonvulsants.


There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of isotretinoin.


In clinical trials for disorders of keratinization, a high prevalence of skeletal hyperostosis was noted with a mean dose of 2.24 mg/kg/day.


Minimal skeletal hyperostosis and calcification of ligaments and tendons has been observed by x-ray in prospective studies of nodular acne patients treated with a single course of therapy at recommended doses. The skeletal effects of multiple isotretinoin treatment courses for acne are unknown.


Hepatotoxicity:
Clinical hepatitis possibly or probably related to isotretinoin therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been seen in approximately 15% of patients, some of whom normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur, or if hepatitis is suspected, stop the drug and further investigate etiology.


Hearing impairment:
Impaired hearing has been reported in patients taking isotretinoin;in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanisms and causality for this event have not been established. Patients who experience tinnitus or hearing impairment should discontinue isotretinoin treatment and be referred to specialized care for further evaluation.


Hormonal contraceptives:
Microdosed progesterone preparations (minipills) may be an inadequate method of contraception during isotretinoin therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from women who have used combined oral contraceptives, as well as injectable/implantable contraceptive products. These reports are more frequent for women who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with isotretinoin. Therefore, it is critically important that women of childbearing potential use 2 effective forms of contraception simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy (see Warning Box).


Hypersensitivity reactions:
Anaphylactic reactions and other allergic reactions have been reported. Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura (bruises and red patches), of the extremities and extracutaneous involvement (including renal) have been reported. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical management.


Carcinogenesis:
In male and female Fischer 344 rats given oral isotretinoin at dosages of 8 or 32 mg/kg/day (1.3 to 5.3 times the recommended clinical dose of 1 mg/kg/day, respectively, after normalization for total body surface area) for more than 18 months, there was a dose-related increased incidence of pheochromocytoma relative to controls. The incidence of adrenal medullary hyperplasia also was increased at the higher dosage in both sexes.


Pregnancy:
Category X (see Warning Box).


Lactation:
It is not known whether this drug is excreted in breast milk. Because of the potential for adverse effects, do not give to a nursing mother.


Children:
The use of isotretinoin in pediatric patients less than 12years of age has not been studied. Carefully consider isotretinoin use in pediatric patients 12 to 17 years of age, especially for those patients in whom a known metabolic or structural bone disease exists.
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