Side effects of isotretinoin

Isotretinoin

Isotretinoin is the active ingredient in a prescription drug available under the brand names Sortret, Zenatane, Myorisane, Claravis, Amnesteem, and Absorica.

Doctors prescribe isotretinoin to treat a severe form of acne called recalcitrant nodular or cystic acne.

The Food and Drug Administration (FDA) originally approved isotretinoin as the brand name Accutane in 1982. Hoffmann La Roche manufactured it.

Hoffmann La Roche stopped making Accutane in 2009, partly due to numerous class action lawsuits filed against the company for birth defects caused by the drug.

In addition, plaintiffs’ complaints included Crohn’s disease, depression, suicide, and disabilities that caused them to miss work and lose wages.

Isotretinoin and Birth Defects

Today, women and men must agree to follow guidelines in iPLEDGE program before taking isotretinoin.

iPLEDGE requires that you and your doctor and pharmacist follow certain detailed steps to ensure your safety and prevent pregnancy while you are being treated with the drug.

Although requirements vary according to your gender and stage of life, iPLEDGE requires that people who are able to reproduce use two forms of birth control while taking isotretinoin.

Your doctor will enroll you in the iPLEDGE program. Then, before filling your prescription, your pharmacist will verify your enrollment and make sure you meet the program’s requirements.

Isotretinoin and Hair Loss

One major side effect of isotretinoin is that it dries tissues, causing dry skin, cracked lips, dry mucous membranes, and dry scalp.

It may thin hair or cause it to become dry, brittle, and fragile.

This happens because isotretinoin slows down or blocks the production and secretion of the body’s on own natural oils.

According to anecdotal reports, isotretinoin may not only thin hair on the head but also on the face, causing a loss of eyelashes and eyebrows.

Some people may become bald.

Although hair may regrow a few months after stopping isotretinoin, some people report that it took several years.

Others say isotretinoin caused permanent hair loss.

Isotretinoin Warnings

The FDA has issued two black-box warnings for isotretinoin.

One requires anyone taking it comply with the iPLEDGE program.

The second bans isotretinoin from being prescribed to women who are either pregnant or are able to become pregnant.

The FDA also cautions people who use isotretinoin that it can cause serious skin reactions, some of which can be life threatening.

You should not take isotretinoin if you are:

  • Pregnant or planning on getting pregnant
  • Allergic to isotretinoin or any other ingredients found in the drug
  • Allergic to soybean oil
  • Breastfeeding

Talk to your doctor before taking isotretinoin if you have:

  • Certain mood or mental conditions
  • Bone cancer
  • Soft or brittle bones and are prone to bone breaks (osteomalacia or osteoporosis)
  • Diabetes mellitus
  • Anorexia
  • High cholesterol

Pregnancy and Isotretinoin

Isotretinoin can cause severe birth defects and miscarriages. It should never be taken during pregnancy.

Isotretinoin passes into breast milk, so it also isn’t safe to take while breastfeeding.

Accutane

SIDE EFFECTS

Clinical Trials and Postmarketing Surveillance

The adverse reactions listed below reflect the experience from investigational studies of Accutane (isotretinoin) , and the postmarketing experience. The relationship of some of these events to Accutane (isotretinoin) therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Accutane (isotretinoin) are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, eg, 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 (see WARNINGS and ADVERSE REACTIONS).

Body as a Whole

allergic reactions, including vasculitis, systemic hypersensitivity (see PRECAUTIONS: Hypersensitivity), edema, fatigue, lymphadenopathy, weight loss

Cardiovascular

palpitation, tachycardia, vascular thrombotic disease, stroke

Endocrine/Metabolic

hypertriglyceridemia (see WARNINGS: Lipids), alterations in blood sugar levels (see PRECAUTIONS: Laboratory Tests)

Gastrointestinal

inflammatory bowel disease (see WARNINGS: Inflammatory Bowel Disease), hepatitis (see WARNINGS: Hepatotoxicity), pancreatitis (see WARNINGS: Lipids), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms

Hematologic

allergic reactions (see PRECAUTIONS: Hypersensitivity), anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis (see PATIENT INFORMATION). See PRECAUTIONS: Laboratory Tests for other hematological parameters.

Musculoskeletal

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

Neurological
Psychiatric

suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors (see WARNINGS: Psychiatric Disorders), 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 PATIENT INFORMATION)

Special Senses

Hearing – hearing impairment (see WARNINGS: Hearing Impairment), tinnitus.

Vision- corneal opacities (see WARNINGS: Corneal Opacities), decreased night vision which may persist (see WARNINGS: Decreased Night Vision), cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances

Urinary System

glomerulonephritis (see PRECAUTIONS: Hypersensitivity), nonspecific urogenital findings (see PRECAUTIONS: Laboratory Tests for other urological parameters)

Laboratory

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

Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH (see WARNINGS: Hepatotoxicity)

Elevation of fasting blood sugar, elevations of CPK (see PRECAUTIONS: Laboratory Tests), hyperuricemia

Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see PATIENT INFORMATION), elevated sedimentation rates, elevated platelet counts, thrombocytopenia

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

Read the entire FDA prescribing information for Accutane (Isotretinoin)

Ask the experts

I’m a young woman with bad acne. I’ve heard Accutane is very good for acne, but is dangerous. When is Accutane used and what problems can occur from it?

Doctor’s Response

People with severe acne that does not respond to other medications are candidates for taking Accutane. Accutane is the brand name for isotretinoin, a class of drugs called retinoids.

Isotretinoin (Accutane) is taken by mouth, usually once or twice a day for 16 to 20 weeks. It appears to reduce the size of the oil glands so that much less oil is produced. It also reduces cell shedding and the stickiness of cells in the follicles. Isotretinoin (Accutane) is generally very effective in helping prevent extensive scarring in patients with severe acne. After 16 to 20 weeks of treatment, their acne is completely (or nearly completely) one in most (up to 90%) of cases. For some people, however, the acne will come back, and they will need additional treatment with isotretinoin.

All acne patients should carefully consider the several disadvantages of isotretinoin. The drug is not only expensive but it also has some significant adverse effects. Possible side effects include inflammation of the lip and mucous membrane of the eye; dry mouth, nose, or skin; itching; nosebleeds; muscle aches; photosensitivity; and, rarely, decreased night vision. Other more serious side effects include increased blood cholesterol, lipid, and triglyceride levels and abnormal liver enzymes. To make sure isotretinoin is stopped if these side effects occur, the doctor usually monitors a patient’s complete blood count, blood chemistries, cholesterol, triglycerides, and liver enzymes before therapy is started and periodically during treatment. All of these side effects usually go away after the medication is stopped. If you experience side effects while using isotretinoin, you should tell your doctor. The doctor may be able to reduce the dose of the drug so that the side effects are decreased or stopped.

The most alarming adverse effect of isotretinoin (Accutane) is that it is teratogenic: it can cause birth defects in the developing fetus if a woman takes it during pregnancy. Therefore, it is crucial that women of childbearing age are NOT pregnant and do NOT get pregnant while taking isotretinoin.

If you (or any woman in the childbearing years) is to take isotretinoin (Accutane), you must use an appropriate birth control method for 1 month before therapy begins, during the entire course of therapy, and for 1 full month after therapy stops. You should talk to your doctor about when it is safe to get pregnant after the treatment with isotretinoin (Accutane) has been stopped.

In sum, isotretinoin (Accutane) is highly effective in clearing up severe acne but it is does have some side effects and it is dangerous for women during pregnancy because it can cause birth defects in their children. As with all medications, you should only take isotretinoin (Accutane) with caution

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Medically reviewed by Drugs.com on Nov 22, 2019 – Written by Cerner Multum

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What is isotretinoin?

Isotretinoin is a form of vitamin A that is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Isotretinoin is available only from a certified pharmacy under a special program called iPLEDGE.

Isotretinoin may also be used for purposes not listed in this medication guide.

Important Information

Isotretinoin in just a single dose can cause severe birth defects or death of a baby. Never use isotretinoin if you are pregnant or may become pregnant.

You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.

Before taking this medicine

Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby’s ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking isotretinoin, before each prescription is refilled, right after you take your last dose of isotretinoin, 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 isotretinoin and ending 30 days after your last dose. 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 with or without spermicide;

  • a diaphragm plus a spermicide;

  • a cervical cap plus a spermicide; and

  • a vaginal sponge containing a spermicide.

Stop using isotretinoin 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. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

You should not use isotretinoin if you are allergic to it.

Tell your doctor if you have ever had:

  • depression or mental illness;

  • asthma;

  • liver disease;

  • diabetes;

  • heart disease or high cholesterol;

  • osteoporosis or low bone mineral density;

  • an eating disorder such as anorexia;

  • a food or drug allergy; or

  • an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.

You should not breastfeed while using this medicine.

Isotretinoin is not approved for use by anyone younger than 12 years old.

How should I take isotretinoin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

Always take isotretinoin with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Follow all directions about taking isotretinoin with or without food.

Use isotretinoin for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.

You may need frequent blood tests.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.

What should I avoid while taking isotretinoin?

Do not take a vitamin or mineral supplement that contains vitamin A.

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

While you are taking isotretinoin and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.

Isotretinoin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid driving or hazardous activity until you know how isotretinoin will affect you. Isotretinoin may impair your vision, especially at night.

Isotretinoin side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using isotretinoin and call your doctor at once if you have:

  • problems with your vision or hearing;

  • muscle or joint pain, bone pain, back pain;

  • increased thirst, increased urination;

  • hallucinations, (see or hearing things that are not real);

  • symptoms of depression–unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;

  • signs of liver or pancreas problems–loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);

  • severe stomach problems–severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or

  • increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

  • dryness of your skin, lips, eyes, or nose (you may have nosebleeds);

  • vision problems;

  • headache, back pain, joint pain, muscle problems;

  • skin reactions; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Isotretinoin dosing information

Usual Adult Dose for Acne:

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
Maximum dose: Up to 2 mg/kg/day
Duration of therapy: Up to 20 weeks

-Patients should take some formulations of this drug with food.
-Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).
-Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.
-Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.
-The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.
Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Usual Pediatric Dose for Acne:

12 years or older:
-Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
-Maximum dose: 2 mg/kg/day
-Duration of therapy: Up to 20 weeks

-Patients should take some formulations of this drug with food.
-Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).
-Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.
-Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.
-The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.
Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

What other drugs will affect isotretinoin?

Tell your doctor about all your other medicines, especially:

  • phenytoin;

  • St. John’s wort;

  • vitamin or mineral supplements;

  • progestin-only birth control pills (mini-pills);

  • steroid medicine; or

  • a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may affect isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 12.01.

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Treatment of severe acne hampered by antibiotic overuse, delays in prescribing more potent medication

According to Orlow, antibiotic therapy can be very effective for inflammatory types of acne. And switching to different antibiotics is routine practice when another antibiotic has failed to reduce symptoms. However, Orlow says clinical guidelines recommend limiting such antibiotic therapy to two months to three months each, or six months overall, unless significant improvements are seen.

“Physicians and patients have become far too complacent about antibiotic overuse and its subsequent danger of increasing microbial drug resistance,” says Orlow. The problem, he notes, is compounded by disruptions in patient care from patients changing physicians or health plans. Orlow says a lot of time is wasted while continuing antibiotic therapy during these intervals when treatment failure is visibly evident.

Lead study investigator and dermatologist Arielle Nagler, MD, says fears about isotretinoin side effects, as well as federal restrictions meant to prevent use of the medication during pregnancy, have also all helped contribute to prolonged antibiotic overuse and delayed access to the drug.

Nagler acknowledges that the risk of side effects is real, but says protocols are in place to prevent or carefully manage them. Among these is the iPledge registry set up by the Food and Drug Administration in 2006, which requires all patients, physicians and pharmacists to track isotretinoin prescriptions and side effects and to monitor compliance by women of child-bearing age with monthly pregnancy tests. She notes, however, that registration delays or technical holdups often keep patients from getting their medications as prescribed by as much as a month.

“Acne remains the number one reason for young people to visit a dermatologist, and there are no other medications as effective as isotretinoin for treating severe cases of the skin condition,” says Nagler, an instructor at NYU Langone, which also funded the study. “We need to find a better balance between trying antibiotics that may work and getting isotretinoin quickly to patients for whom antibiotics are not working.

“Physicians also need to start talking to their acne patients earlier about possible isotretinoin therapy, so when and if they do need to switch to it, patients are more receptive to the drug and any concerns about side effects have already begun to be addressed,” says Nagler.

After spending years entombing my own failed remedies beneath my sink, my senior year of high school I tried the first and last acne medication that would have a lasting impact. Isotretinoin (commonly referred to by one of its brand names, Accutane, even though its manufacturer pulled it from the market in 2009) was like a pimple’s kryptonite. I took two pills a day for six months and it crippled my acne for the long-term.

But why does isotretinoin work so well? “We don’t really know,” said Joslyn Kirby, professor of dermatology at Penn State College of Medicine. “That’s part of the research that people at our group at Penn State are doing is looking into some of the changes in the oil glands in the skin called the sebaceous glands, and what is happening to the cells that might explain … this sustained improvement.”

What we do know is that the drug ultimately reduces inflammation and makes pores less hospitable to bacteria, Kirby said. It depends on the severity of the acne and how high patients and doctors decide to crank up the dosage, but the average length of treatment is four to six months. While a higher dosage, within safe limits, can reduce the amount of time on the drug, it can also make the side effects more intense.

These side effects contribute to why isotretinoin is often a last resort for curing severe acne. Extremely dry skin is one of the most common effects of the drug, but since it became FDA-approved to treat acne in 1982 it has also been linked to inflammatory bowel disease, depression, and increased rates of suicide. While studies have not proven that isotretinoin causes these conditions, they remain among the risks of taking the medication. Other serious but rare side effects include joint and muscle pain, eyesight trouble, and liver damage. Due to the drug’s impact on the liver, patients are advised not to drink and their liver enzymes are monitored throughout treatment. Much to my high-school friends’ delight, this made me the designated driver the majority of our senior year. If I had much more than a beer, it would show in my blood work and I was admonished by my doctor and my mom—something no teen wants to experience.

Isotretinoin also causes miscarriages and severe birth defects if taken while pregnant. This has led to strict and cumbersome regulations. Just being able to pick up the medication each month required jumping through a series of pharmaceutical and medical hoops. The process starts with a visit to the lab for blood work. For women, the blood sample is used for a pregnancy test, and for all patients it’s used to monitor liver enzymes and blood fat levels, which the medication can cause to rise.

Patients are also required to participate in the iPledge online program. The program aims to prevent pregnancy by having patients confirm they understand the risks of the medication, promise to keep monthly appointments with their doctor, and agree not to share the medicine or donate blood while taking the drug. Each month, women must also answer a series of comprehension questions about birth control, and their prescribers must confirm results of a negative pregnancy test.

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