on 4/16/03 7:33 AM, C Creel at [email protected] wrote:
> Because it is a high-risk drug, Accutane should be reserved for cases of > "severe recalcitrant nodular acne," according to the product's labeling. > This type of acne is resistant to standard acne treatment, including oral > antibiotics, and is characterized by many nodules or cysts--inflammatory > lesions filled with pus and lodged deep within the skin. These lesions can > cause pain, permanent scarring, and negative psychological effects. > > > This is about 10% of the possible adverse reactions one can have to > Accutane. > > > INDICATIONS AND USAGE: Severe Recalcitrant Nodular Acne: Accutane is > indicated for the treatment of severe recalcitrant nodular acne. Nodules are > inflammatory lesions with a diameter of 5 mm or greater. The nodules may > become suppurative or hemorrhagic. "Severe," by definition, means "many" as > opposed to "few or several" nodules. Because of significant adverse effects > associated with its use, Accutane should be reserved for patients with > severe nodular acne who are unresponsive to conventional therapy, including > systemic antibiotics. > > > Contraindications and Warnings Psychiatric Risk Management-Accutane > > WARNINGS > > Psychiatric Disorders: Accutane may cause depression, psychosis and, > rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of > Accutane therapy may be insufficient; further evaluation may be necessary. > No mechanism of action has been established for these events. > > Pseudotumor Cerebri: Accutane use has been associated with a number of > cases of pseudotumor cerebri (benign intracranial hypertension), some of > which involved concomitant use of tetracyclines. Concomitant treatment with > tetracyclines should therefore be avoided. Early signs and symptoms of > pseudotumor cerebri include papilledema, headache, nausea and vomiting, and > visual disturbances. Patients with these symptoms should be screened for > papilledema and, if present, they should be told to discontinue Accutane > immediately and be referred to a neurologist for further diagnosis and care. > > ADVERSE REACTIONS Neurological: pseudotumor cerebri, dizziness, drowsiness, > headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, > stroke, syncope, weakness. > > Psychiatric: suicidal ideation, suicide attempts, suicide, depression, > psychosis, emotional instability. Of the patients reporting depression, > some reported that the depression subsided with discontinuation of therapy > and recurred with reinstitution of therapy. > > > > Accutane (isotretinoin) Accutane is a retinoid related to vitamin A. > Patients should be advised against taking vitamin supplements containing > vitamin A to avoid additive toxic effects. > > Pancreatitis: Acute pancreatitis has been reported in patients with either > elevated or normal serum triglyceride levels. In rare instances, fatal > hemorrhagic pancreatitis has been reported. Accutane should be stopped if > hypertriglyceridemia cannot be controlled at an acceptable level or if > symptoms of pancreatitis occur. > > Lipids: Elevations of serum triglycerides have been reported in patients > treated with Accutane. Marked elevations of serum triglycerides in excess of > 800 mg/dL were reported in approximately 25% of patients receiving Accutane > in clinical trials. In addition, approximately 15% developed a decrease in > high-density lipoproteins and about 7% showed an increase in cholesterol > levels. In clinical trials, the effects on triglycerides, HDL, and > cholesterol were reversible upon cessation of Accutane therapy. Some > patients have been able to reverse triglyceride elevation by reduction in > weight, restriction of dietary fat and alcohol, and reduction in dose while > continuing Accutane. Blood lipid determinations should be performed before > Accutane is given and then at intervals until the lipid response to Accutane > is established, which usually occurs within 4 weeks. Especially careful > consideration must be given to risk/benefit for patients who may be at > highrisk during Accutane therapy (patients with diabetes, obesity, increased > alcohol intake, lipid metabolism disorder or familial history of lipid > metabolism disorder). If Accutane therapy is instituted, more frequent > checks of serum values for lipids and/or blood sugar are recommended. > > 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. Mechanism(s) and causality for this > event have not been established. Patients who experience tinnitus or hearing > impairment should discontinue Accutane treatment and be referred for > specialized care for further evaluation. > > Hepatotoxicity: Clinical hepatitis considered to be possibly or probably > related to Accutane therapy has been reported. Additionally, mild to > moderate elevations of liver enzymes have been observed in approximately 15% > of individuals treated during clinical trials, some of which normalized with > dosage reduction or continued administration of the drug. If normalization > does not readily occur or if hepatitis is suspected during treatment with > Accutane, the drug should be discontinued and the etiology further > investigated. > > Inflammatory Bowel Disease: Accutane has been associated with inflammatory > bowel disease (including regional ileitis) in patients without a prior > history of intestinal disorders. In some instances, symptoms have been > reported to persist after Accutane treatment has been stopped. Patients > experiencing abdominal pain, rectal bleeding or severe diarrhea should > discontinue Accutane immediately. > > > > 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. It is important that > Accutane be given at the recommended doses for no longer than the > recommended duration. > > Hyperostosis: A high prevalence of skeletal hyperostosis was noted in > clinical trials for disorders of keratinization with a mean dose of 2.24 > mg/kg/day. Additionally, skeletal hyperostosis was noted in 6 of 8 patients > in a prospective study of disorders of keratinization. Minimal skeletal > hyperostosis and calcification of ligaments and tendons have also 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 Accutane treatment courses for acne are unknown. > > > > Premature Epiphyseal Closure: There are spontaneous reports of premature > epiphyseal closure in acne patients receiving recommended doses of Accutane. > The effect of multiple courses of Accutane on epiphyseal closure is unknown. > > Vision Impairment: Visual problems should be carefully monitored. All > Accutane patients experiencing visual difficulties should discontinue > Accutane treatment and have anophthalmological examination (see ADVERSE > REACTIONS: Special Senses). > > Corneal Opacities: Corneal opacities have occurred 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 (see ADVERSE REACTIONS: Special Senses). > > 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 problem and warned to be cautious when > driving or operating any vehicle at night. > > PRECAUTIONS: The Accutane Pregnancy Prevention and Risk Management Programs > consist of the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.) > and the Accutane Pregnancy Prevention Program (PPP). S.M.A.R.T. should be > followed for prescribing Accutane with the goal of preventing fetal exposure > to isotretinoin. It consists of: 1) reading the booklet entitled System to > Manage Accutane Related Teratogenicity (S.M.A.R.T.) Guide to Best Practices, > 2) signing and returning the completed S.M.A.R.T. Letter of Understanding > containing the Prescriber Checklist, 3) a yellow self-adhesive Accutane > Qualification Sticker tobe affixed to the prescription page. In addition, > the patient educational material, Be Smart, Be Safe, Be Sure, should be used > with each patient. > > > > Patients may report mental health problems or family history of psychiatric > disorders. These reports should be discussed with the patient and/or the > patient's family. A referral to a mental health professional may be > necessary. The physician should consider whether or not Accutane therapy is > appropriate in this setting. > > Patients should be informed that they must not share Accutane with anyone > else because of the risk of birth defects and other serious adverse events. > > Patients should not donate blood during therapy and for 1 month following > discontinuance of the drug because the blood might be given to a pregnant > woman whose fetus must not be exposed to Accutane. > > Patients should be reminded to take Accutane with a meal. To decrease the > risk of esophageal irritation, patients should swallow the capsules with a > full glass of liquid. > > Patients should be informed that transient exacerbation (flare) of acne has > been seen,generally during the initial period of therapy. > > Wax epilation and skin resurfacing procedures (such as dermabrasion, laser) > should be avoided during Accutane therapy and for at least 6 months > thereafter due to the possibility of scarring. > > Patients should be advised to avoid prolonged exposure to UV rays or > sunlight. > > Patients should be informed that they may experience decreased tolerance to > contact lenses during and after therapy. > > Patients should be informed that approximately 16% of patients treated with > Accutane in a clinical trial developed musculoskeletal symptoms (including > arthralgia) during treatment. In general, these symptoms were mild to > moderate, but occasionally required discontinuation of the drug. Transient > pain in the chest has been reported less frequently. In the clinical trial, > these symptoms generally cleared rapidly after discontinuation of Accutane, > but in some cases persisted. There have been rare postmarketing reports of > rhabdomyolysis, some associated with strenuous physical activity > (Rhabdomyolysis is a life-threatening colapse of the skeletal muscle that > allows toxins from cells to leak into the bloodstream). > > > > Pediatric patients and their caregivers should be informed that > approximately 29% (104/358) of pediatric patients treated with Accutane > developed back pain. Back pain was severe in 13.5% (14/104) of the cases and > occurred at a higher frequency in female than male patients. > > Arthralgias were experienced in 22% (79/358) of pediatric patients. > Arthralgias were severe in 7.6% (6/79) of patients. Appropriate evaluation > of the musculoskeletal system should be done in patients who present with > these symptoms during or after a course of Accutane. > > Hypersensitivity: 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. > > Glucose: Some patients receiving Accutane have experienced problems in the > control of their blood sugar. In addition, new cases of diabetes have been > diagnosed during Accutane therapy, although no causal relationship has been > established. > > Carcinogenesis, Mutagenesis and Impairment of Fertility: 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 1.0 mg/kg/day, > respectively, after normalization for total body surface area) for greater > than 18 months, there was a dose-related increased incidence of > pheochromocytoma (a cortisol-producing tumor that induces Cushing's > Syndrome) relative to controls. The incidence of adrenal medullary > hyperplasia was also increased at the higher dosage in both sexes. The > relatively high level of spontaneous pheochromocytomas occurring in the male > Fischer 344 rat makes it an equivocal model for study of this tumor; > therefore, the relevance of this tumor to the human population is uncertain. > > Regards, > Catherine > > > > > -- > The silver-list is a moderated forum for discussion of colloidal silver. > > Instructions for unsubscribing may be found at: http://silverlist.org > > To post, address your message to: [email protected] > > Silver-list archive: http://escribe.com/health/thesilverlist/index.html > > List maintainer: Mike Devour <[email protected]> > My friend's son who was on a acne medication killed himself with a rifle
