Drug Enquirer

NEWS AND FACTS ABOUT MEDICINES YOU TAKE

Accutane may cause serious mental health problems including: depression, psychosis (seeing or hearing things that are not real) and suicide.

ABOVE: Roche Laboratories Inc., “Accutane Medication Guide,” rev. 8/05.
Accutane
Accutane has a long history of controversy over birth defects, depression and suicide, and other serious medical problems.

Accutane Side Effects and Warnings

Dosage Forms

Brand Names How Much Isotretinoin in Each Capsule
Accutane 10 mg 20 mg 40 mg contains soybean oil and parabens*
Amnesteem 10 mg 20 mg 40 mg contains soybean oil
Claravis 10 mg 20 mg 40 mg contains soybean oil
Sotret 10 mg 20 mg 40 mg contains soybean oil and parabens*
*Accutane contains parabens, which are chemical preservatives known to display estrogenic activity and mimic the body's hormones. These chemical-disruptors may interfere with the body-s endocrine system: the adrenal glands, the pituitary gland, the hypothalamus (in the brain), the thyroid, the ovaries and testes, the pancreas (which secretes insulin and regulates the level of glucose in the blood), the stomach, the kidneys, the skin and virtually every body system.

How Does Accutane (isotretinoin) Work?

Accutane (isotretinoin) inhibits the body's cell growth and reproduction, and oil-gland function.

Accutane also depletes the body's water-holding molecules, which bind, lubricate and protect tissue in the skin, scalp, eyes and joints.

A blinded, randomized study was conducted to determine whether vitamin E would reduce the toxicity and side effects of Accutane and the results showed that vitamin E does not.

ABOVE: Kus, S., et al. "Vitamin E does not reduce the side-effects of isotretinoin in the treatment of acne vulgaris." Int J Dermatol 2005;44(3):248-51.

Common Reactions to Accutane

Serious Reactions to Accutane

Accutane (isotretinoin) is Used for

A two-year U.S. congressional investigation found that many dermatologists have effectively widened the scope of Accutane use to include even mild acne despite the fact that the drug is approved for only the most severe, scar-forming and disfiguring nodular acne, which is untreatable by other means. The government found that 90 percent of women and nearly half the teens who received Accutane suffered only mild cases of acne. Therein lies the controversy surrounding this high-risk drug.

The Power of Accutane:
Benefits and Risks of Isotretinoin

Accutane is a very powerful drug that certainly works miracles to clear up acne in a matter of months. One course, which is typically five months, results in prolonged remission of acne in up to 85 percent of patients. "But as powerful as Accutane can be in improving patients' lives, the adverse effects can be just as powerful," states FDA Consumer magazine. "The drug is known to cause miscarriage and severe birth defects. Patients taking Accutane may develop potentially serious problems affecting a number of organs, including the liver, intestines, eyes, ears, and skeletal system. And some patients taking Accutane have developed serious psychiatric problems."

Many former Accutane users say their hair, eyebrows, or eyelashes have fallen out months, or even years, after stopping the drug. Some claim their hair loss is permanent.

Why does Accutane hair-loss happen?

Accutane causes hair loss because it impacts the oil-gland function of the skin (including the scalp) and causes changes in cells that provide structure to hair and skin, all of which leads to hair and skin dryness and fragility, which can cause hair-thinning, hair-loss, and even baldness.

Current and former Accutane users attribute aches and joint pains to the acne drug. A 37-year-old nurse with cystic acne claims Accutane caused her to develop permanent, severe low-back pain, severe joint pain and thinning hair. She writes: "Now, almost 7 years later, I suffer from severe back and generalized joint pain to the point I can no longer work full-time. Before Accutane, I was a healthy, active young woman. It definitely ages you prematurely. If you haven't had these awful symptoms, count yourself blessed."

Experts agree that alternatives without serious side effects should be tried first.

Accutane (isotretinoin) is the first drug in the history of medicine for which a woman has to sign a consent to read the warnings.

FDA "Black Box" Warning

The Food and Drug Administration (FDA) requires the following "black box" warning on isotretinoin, including Accutane, Amnesteem, Claravis, and Sotret, which means that medical studies indicate these drugs carry a significant risk of serious, or even life-threatening, adverse effects.

CONTRAINDICATIONS AND WARNINGS

Accutane causes birth defects - Do Not Get Pregnant

Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements

Because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE.

ABOVE: Roche Lab. Inc., Accutane Package Insert, rev. 10/07.
Warnings from Drug Maker's Guide

Accutane (isotretinoin) causes VERY SEVERE BIRTH DEFECTS including:

Illustration of very severe birth defects caused by Accutane: skull shape, small chin, enlarged skull, deformed or missing ears

Read the Medication Guide that comes with Accutane before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about ACCUTANE?

  • Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
  • Because Accutane can cause birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
  • Accutane may cause serious mental health problems.

1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Accutane. Female patients must not get pregnant:

  • for 1 month before starting Accutane
  • while taking Accutane
  • for 1 month after stopping Accutane.

If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

  • FDA MedWatch at 1-800-FDA-1088, and
  • the iPLEDGE pregnancy registry at 1-800-495-0654

2. Serious mental health problems. Accutane may cause:

  • depression
  • psychosis (seeing or hearing things that are not real)
  • suicide. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives.

Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptom of depression or psychosis:

  • start to feel sad or have crying spells
  • lose interest in activities you once enjoyed
  • sleep too much or have trouble sleeping
  • become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
  • have a change in your appetite or body weight
  • have trouble concentrating
  • withdraw from your friends or family
  • feel like you have no energy
  • have feelings of worthlessness or guilt
  • start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
  • start acting on dangerous impulses
  • start seeing or hearing things that are not real

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

ABOVE: Roche Laboratories Inc., “Accutane Medication Guide,” rev. 8/05.
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