Amnesteem Side Effects

Generic Name: isotretinoin

Please note - some side effects for Amnesteem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Amnesteem Side Effects - for the Professional

Amnesteem

Clinical Trials and Post-marketing Surveillance

The adverse reactions listed below reflect the experience from investigational studies of Amnesteem, and the post-marketing experience. The relationship of some of these events to Amnesteem therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Amnesteem are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage and eyes).

Dose Relationship

Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy.

Body as a Whole: allergic reactions, including vasculitis, systemic hypersensitivity, edema, fatigue, lymphadenopathy, weight loss

Cardiovascular: palpitation, tachycardia, vascular thrombotic disease, stroke

Endocrine/Metabolic: hypertriglyceridemia, alterations in blood sugar levels

Gastrointestinal: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms

Hematologic: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis. See PRECAUTIONS: Laboratory Tests for other hematological parameters

Musculoskeletal: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia, transient pain in the chest, arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis

Neurological: pseudotumor cerebri, dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness

Psychiatric: suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors, emotional instability

Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System: abnormal menses

Respiratory: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration

Skin and Appendages: acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas,7 erythema multiforme, 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), Stevens-Johnson Syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, 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)

Special Senses: Hearing: hearing impairment, tinnitus

Vision:corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances

Urinary System: glomerulonephritis, nonspecific urogenital findings

Laboratory

Elevation of plasma triglycerides, decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment

Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH

Elevation of fasting blood sugar, elevations of CPK, hyperuricemia

Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see PRECAUTIONS: Information for Patients), elevated sedimentation rates, elevated platelet counts, thrombocytopenia

White cells in the urine, proteinuria, microscopic or gross hematuria

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Side Effects by Body System - for Healthcare Professionals

General

In general, many side effects associated with isotretinoin are similar to those associated with very high doses of vitamin A (dryness of the skin and mucous membranes).

Dermatologic

Dermatologic side effects have included cheilitis, severe mucosal drying, dry mouth, dry nose, dry skin, acne fulminans, flare of cystic acne, alopecia (persistent in some cases), epistaxis, eruptive xanthomas, erythema multiforme, skin fragility, hair abnormalities (including thinning of the hair), hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, palmoplantar desquamation, photoallergic/photosensitizing reactions, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, increased sunburn susceptibility, sweating, toxic epidermal necrolysis, urticaria, abnormal wound healing (delayed healing or exuberant granulation tissue with crusting), and pruritus. Keloid formation and pyoderma gangrenosum have been reported.

A few patients have experienced keloid formation on the face when isotretinoin was administered in conjunction with dermabrasion. Formation generally occurred between one and four months after dermabrasion. Keloid formation has occurred in patients who had been off isotretinoin for up to six months before dermabrasion was completed. Isotretinoin inhibits collagenase, which may result in accumulation of collagen and the formation of hypertrophic scars and keloids.

Metabolic

Metabolic side effects have included hypertriglyceridemia, altered blood sugar levels (including elevated fasting blood sugar), hyperuricemia, decreased serum high-density lipoprotein levels, and elevated lactate dehydrogenase, serum cholesterol, and alkaline phosphatase. An association between isotretinoin and an unmasking of latent autoimmune diabetes has been reported in at least 1 case.

Ocular

Ocular side effects have included corneal opacities, decreased night vision (persistent in some cases), cataracts, color vision disorder, conjunctivitis, blepharitis, keratitis, optic neuritis, eye irritation, photophobia, visual disturbances (including blurred vision), and dry eye syndrome. At least one case of transient myopia has been reported.

Dry eye syndrome, blepharitis, and conjunctivitis are due the drying effects of isotretinoin and the destabilization of tear-film caused by alterations in meibomian gland function and structure. They are commonly seen within the first four weeks of therapy and are reversible upon the discontinuation of medication. Bacterial conjunctivitis may also occur due to increased colonization of Staphylococcus aureus in the conjunctival sac.

A case reported that blurred vision and photophobia resolved quickly after stopping therapy, but decreased night vision persisted for several months.

Musculoskeletal

Osteophytes generally form in the axial skeleton, especially the cervical spine, of patients receiving long-term therapy. Osteophytes also occur more frequently in patients receiving dosages greater than 2 mg/kg/day. One patient with a previous rhinoplasty experienced bilateral nasal bone osteophytes after five weeks of isotretinoin therapy.

Myalgias and arthralgias that are mild and transient generally do not require discontinuation of therapy. Many patients with myalgias also have small hyperostotic lesions of the spine.

One patient, treated with isotretinoin for promyelocytic leukemia, developed myositis, fever, and pleural effusion that slowly resolved after isotretinoin was discontinued.

Causality for osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have not been established, although an effect cannot be ruled out. Longer term effects have not been studied.

Musculoskeletal side effects have included skeletal hyperostosis; calcification of tendons and ligaments; premature epiphyseal closure; decreased bone mineral density; musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia; transient chest pain; arthritis; tendonitis; other types of bone abnormalities; elevated creatine phosphokinase; and rare postmarketing reports of rhabdomyolysis. Muscular and joint pain, mild to moderate in severity, generally resolved following discontinuation of therapy. Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been reported. At least one case of myositis and several cases of osteophytes have been reported.

Psychiatric

A large retrospective population-based cohort study (n=7195) that analyzed data for isotretinoin users provided no evidence that the use of isotretinoin was associated with an increased risk for depression, suicide, or other psychiatric disorders.

Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when isotretinoin is resumed.

Psychiatric side effects have included depression, nervousness, psychosis, aggression, violent behaviors, emotional instability, suicidal ideation, suicide attempts, and suicide.

Hematologic

Hematologic side effects have included anemia, increased erythrocyte sedimentation rate, leukopenia, thrombocytopenia, neutropenia, and rare reports of agranulocytosis. Laboratory side effects have included decreases in red blood cell parameters, decreases in white blood cell counts, and elevated platelet counts.

Nervous system

Nervous system side effects have included lethargy, headache, dizziness, drowsiness, insomnia, paresthesias, seizures, stroke, syncope, weakness, pseudotumor cerebri, hearing impairment, tinnitus, and Guillain-Barre syndrome. At least one case of cerebral ischemia has been reported.

Areflexic tetraparesis necessitating ventilatory support, preceded by symptoms of lethargy, epistaxis, cough, arthralgias, paresthesia of the feet, and influenza-like symptoms (Guillain-Barre syndrome), was reported in two male patients, a 31-year-old man and a 13-year-old boy, after oral isotretinoin therapy. Both patients received IV immunoglobulin (2 g/kg) and were discharge from hospital within three months. Neither patient was rechallenged with oral isotretinoin. First patient continued to use topical isotretinoin gel without any adverse effects.

A 30-year-old male experienced cerebral ischemia coincident with isotretinoin therapy. He had been given oral isotretinoin 45 mg per day for 3 months for treatment of severe acne. A cerebral computed tomography scan revealed hypodensity in the right middle cerebral territory corresponding to cerebral ischemia. No risk factors were determined. Isotretinoin was discontinued on admission and the adverse event resolved.

Hepatic

Hepatic side effects have included hepatitis and transient elevations in liver function tests (including AST, ALT, and GGTP).

Gastrointestinal

Gastrointestinal side effects have included inflammatory bowel disease, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, and other nonspecific gastrointestinal symptoms. Taste disturbances such as loss of taste have been rarely reported.

Other

Other side effects have included edema, fatigue, malaise, flushing, bruising, lymphadenopathy, and weight loss.

Cardiovascular

Cardiovascular side effects have included palpitation, tachycardia (including atrial tachycardia), vascular thrombotic disease, vasculitis (including Wegener's granulomatosis), and stroke.

A 22-year-old male with nodular acne experienced symptomatic heart palpitations of 1 week's duration coincident with isotretinoin therapy. He had undergone 2 complete courses of isotretinoin therapy without sequelae and was 3 weeks into his third course. A 12-lead electrocardiogram (ECG) showed atrial tachycardia at a rate of 127 beats per minute. The patient was discharged in stable condition. He was seen at follow-up visits 2 days, 1 week, and 3 months later and underwent serial ECGs each time that showed a gradual decline in heart rate and an eventual return to normal sinus rhythm.

Respiratory

Bronchoconstriction and exacerbation of preexisting asthma may be possibly due to the drying effects of isotretinoin on the tracheobronchial tree. In a couple of cases, the condition resolved following discontinuation of therapy, but reoccurred when therapy was reinstituted.

Respiratory side effects have included bronchospasms (with or without a history of asthma), respiratory infection, and voice alteration. Bronchoconstriction and exacerbation of preexisting asthma have been reported in a few patients.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions, allergic vasculitis, systemic hypersensitivity, and anaphylactic reactions.

Renal

Renal side effects have included glomerulonephritis.

Genitourinary

Genitourinary side effects have included abnormal menses, white cells in the urine, proteinuria, hematuria (microscopic or gross), and nonspecific urogenital findings.

Immunologic

Immunologic side effects have included a case report of isotretinoin-induced pemphigus.

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