Hi Can any one tell me what are the side effects of "tretiva capsule" 20mg, if taken for longer duration, Say for about 2 years

This drug is better known as Accutane and is usually used to help with acne.

Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant.

Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking Accutane. Unless you have had a total hysterectomy or have been in menopause for at least a year, you are considered to be of child-bearing potential.

Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign agreements to use birth control and undergo pregnancy testing as required by the program. Read all program brochures and agreements carefully.

It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
What is Accutane?

Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Accutane is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms.

Accutane may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking Accutane?

Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Read all of the iPLEDGE program brochures and agreements carefully. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.

It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
Do not use this medication if you are allergic to Accutane or to parabens, or if you are pregnant or may become pregnant.

Before taking Accutane, tell your doctor if you are allergic to any foods or drugs, or if you have:

*

A personal or family history of depression or mental illness;
*

Heart diease, high cholesterol or triglycerides;
*

Osteoporosis or other bone disorders;
*

Diabetes;
*

Asthma;
*

An eating disroder (anorexia nervosa); or
* liver disease.

If you have any of these conditions, you may not be able to use Accutane, or you may need a dosage adjustment or special tests during treatment.
Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential.

Even women who have had their tubes tied are required to use birth control while taking Accutane.

You must have a negative pregnancy test 30 days before you start taking Accutane. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Accutane, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking Accutane and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

*

Tubal ligation (tubes tied);
*

Vasectomy of the male sexual partner;
*

An IUD (intrauterine device);
*

Estrogen-containing birth control pills (not mini-pills); and
*

Hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

*

A male latex condom plus spermicidal foam or gel;
*

A diaphragm plus spermicidal foam or gel;
*

A cervical cap plus spermicidal foam or gel; and
*

A vaginal sponge containing spermicide.

Do not take St. John's wort, an herbal supplement, if you are using any type of hormonal birth control, including pills, patches, implants, injections, or a vaginal ring. Breakthrough bleeding may occur.

Stop using Accutane and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant.
It is not known whether Accutane passes into breast milk. Do not take Accutane without first talking to your doctor if you are breast-feeding a baby.
How should I take Accutane?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Each prescription of Accutane must be filled within 7 days of the date it was prescribed by your doctor. You will receive no more than a 30-day supply of Accutane at one time.
Always take Accutane with a full glass of water to prevent the capsule from melting in your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as quickly as possible. Take Accutane with food or milk. Take this medication for the entire length of time prescribed by your doctor. Your acne may seem to get worse at first, but should then begin to improve.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.
Never share this medicine with another person, even if they have the same symptoms you have. Store Accutane at room temperature away from moisture, heat, and light.

Info found at Prescription Drug Information, Side Effects, Interactions - Drugs.com

Adverse Reactions Back to Top

Adverse Drug Reaction Overview

The adverse reactions listed below reflect the experience from clinical studies of ACCUTANE (isotretinoin), and the post-marketing experience. The relationship of some of these events to ACCUTANE therapy is unknown.

Many of the side effects and adverse reactions seen or expected in patients receiving ACCUTANE are similar to those described in patients taking high doses of vitamin A.

Clinical Trial and Post-Market Adverse Drug Reactions

Dose Relationship and Duration

Cheilitis and hypertriglyceridemia are usually dose related.

Adverse reactions were generally reversible when therapy was discontinued; however, some have persisted after cessation of therapy.

The most common side effects are mucocutaneous or dermatologic. The common side effects include: cheilitis (96%), facial erythema/dermatitis (55%), dry nose (51%), desquamation (50%), pruritus (30%), dry skin (22%), conjunctivitis (19%), alopecia (13%), irritation of the eyes (11%), rash (<10%). Dryness of the nasal mucosa and pharynx may be associated with mild epistaxis and hoarseness, respectively. Mild to moderate conjunctivitis may be alleviated by use of an ophthalmic ointment. In rare cases, hair loss persisted after treatment was completed.

Approximately 13% of patients experience joint pain during treatment.

Peeling of palms and soles, skin infections, increased susceptibility to sunburn, nonspecific urogenital symptoms, nonspecific gastrointestinal symptoms, headache, fatigue occurred in approximately 5% of patients.

Body as a Whole

weight loss, anemia, lymphadenopathy, vasculitis including Wegener's granulomatosis, allergic vasculitis, allergic responses, and systemic hypersensitivity.

Cardiovascular

edema, transient pain in the chest, palpitations, tachycardia, vascular thrombotic disease, stroke.

Endocrine and Metabolism

new cases of diabetes (see Warnings and Precautions, Endocrine and Metabolism)

Gastrointestinal

nausea, severe diarrhea, mild gastrointestinal bleeding, rectal bleeding, abdominal pain, inflammatory bowel disease (including regional ileitis, colitis and hemorrhage) (see Warnings and Precautions, Gastrointestinal).

Hearing Disorders

tinnitus, impaired hearing at certain frequencies.

Hepatic/Biliary/Pancreatic

Patients treated with ACCUTANE especially those with high triglyceride levels are at risk of developing pancreatitis. Rare cases of fatal pancreatitis and several cases of clinical hepatitis have been reported (see Warnings and Precautions, Hepatic/Biliary/Pancreatic).

Mucocutaneous and Dermatologic

flushing, changes in skin pigment, urticaria, bruising, disseminated herpes simplex, hair problems (other than thinning), hirsutism, erythema nodosum, paronychia, nail dystrophy, pyogenic granuloma, bleeding and inflammation of the gums, acne fulminans, exanthema, sweating, increased formation of granulation tissue, photoallergic/photosensitizing reactions, skin fragility. Acne flare occurs at the start of treatment and persists for several weeks.

During the post-marketing period, erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported to be associated with ACCUTANE (see Warning and Precautions, Serious Skin Reactions).

Musculoskeletal

arthritis, muscle pain (myalgia; elevations of serum CPK values), arthralgia, calcification of ligaments, tendon and tendinitis, reduced bone density, back pain, epiphyses, premature fusion, hyperostosis (see Warnings and Precautions, Musculoskeletal and Hyperostosis).

There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity. However, there is insufficient information to suggest an association between treatment with ACCUTANE and the development of rhabdomyolysis.

Neurologic

seizures, dizziness, nervousness, drowsiness, malaise, weakness, insomnia, lethargy, paresthesia, benign intracranial hypertension (see Warnings and Precautions, Serious Warnings and Precautions, Neurologic).

Ophthalmologic

optic neuritis, photophobia, eye lid inflammation, lenticular cataracts, keratitis, blurred vision, blepharitis, conjunctivitis, papilledema as sign of benign intracranial hypertension and colour vision disturbances. Dry eyes and/or decreased tolerance to contact lenses have also been reported during therapy. In some instances these conditions have persisted after cessation of therapy.

Of 72 patients who had normal pre-treatment ophthalmological examinations, five developed corneal opacities while taking ACCUTANE (all five patients had a disorder of keratinization). Corneal opacities have also been reported in nodular and/or inflammatory acne patients treated with ACCUTANE (see Warnings and Precautions, Ophthalmologic). Decrease in night vision has been reported and in rare instances has persisted (see Warnings and Precautions, Ophthalmologic). Cataracts and visual disturbances have also been reported.

Psychiatric Disorders

depression, psychotic symptoms and, rarely, suicide attempts, suicide, and aggressive and/or violent behaviours (see Warnings and Precautions, Serious Warnings and Precautions, Psychiatric). Depression has been reported during and after therapy. In some of these patients, depression has subsided with discontinuation of therapy and recurred when ACCUTANE therapy was reintroduced. Emotional instability has been reported with ACCUTANE.

Respiratory

respiratory infections. Bronchospasm has been rarely reported; sometimes in patients with pre-history of asthma.

Reproductive System

abnormal menses.

Urinary System

glomerulonephritis.

Laboratory Abnormalities

ACCUTANE therapy induces changes in serum lipids in a significant number of treated subjects. These changes consisted of: elevation of serum triglycerides (25% of patients), mild to moderate decrease in serum high density lipoprotein (HDL) (16% of patients), and minimal elevations of serum cholesterol (7% of patients). Abnormalities of serum triglycerides, HDL and cholesterol were reversible upon cessation of ACCUTANE therapy.

A rise in serum levels of liver enzymes may occur, especially with higher dosages. Although the changes have usually been within the normal range, and may return to baseline levels despite continued treatment, significant increases have occurred in a few cases, necessitating dosage reduction or discontinuation of ACCUTANE (see Warnings and Precautions, Hepatic/Biliary/Pancreatic). An elevated erythrocyte sedimentation rate may also occur (40% of patients).

Other less commonly reported laboratory abnormalities were: Elevated fasting blood sugar, elevated CPK, and hyperuricemia. Decreases in red blood cell parameters, decreases in white blood cell counts, elevated sedimentation rates, elevated platelet counts, thrombocytopenia and anemia. White blood cells in the urine, proteinuria, and red blood cells in the urine.

Reference: e-cps

Regards,
Pratik Sutariya