*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 Isotretinoin Work?
Isotretinoin inhibits the body's cell growth and reproduction, and oil-gland function.
Isotretinoin 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 Isotretinoin 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.
Erectile dysfunction (difficulty in maintaining erection)
Violent behavior/aggression
Psychosis (seeing or hearing things that are not real)
Suicidal ideation (rare)
Suicide attempts
Hearing impairment
Pseudotumor cerebri (swelling pressure in the brain)
Osteopenia/osteoporosis (loss in bone mass and strength/weak and fragile bones)
Hepatotoxicity (liver damage)
Anaphylaxis (rapid and deadly allergic reaction)
Allergic vasculitis (inflammation and damage to blood vessels)
Major birth defects
Cataracts/corneal opacities (can cause a decrease in vision and lead to eventual blindness)
Premature epiphyseal closure (short stature)
Neutropenia (low white blood cell count, which makes the body vulnerable to bacterial and fungal infections)
Agranulocytosis (a serious condition in which white blood cells decrease in number or disappear altogether) (rare)
Rhabdomyolysis (potentially fatal disease that destroys skeletal muscle) (rare)
Inflammatory bowel disease (inflammation of the intestine and resulting in abdominal cramping and persistent diarrhea)
Pancreatitis (inflammation of the pancreas, an organ important in digestion)
Vascular thrombosis (heart attack)
Stroke
Seizures
Isotretinoin is Used for
A two-year U.S. congressional investigation found that many dermatologists have effectively widened the scope of isotretinoin 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 isotretinoin suffered only mild cases of acne. Therein lies the controversy surrounding this high-risk drug.
The Benefits and Risks of Isotretinoin
Isotretinoin 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 isotretinoin 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 isotretinoin may develop potentially serious problems affecting a number of organs, including the liver, intestines, eyes, ears, and skeletal system. And some patients taking isotretinoin have developed serious psychiatric problems."
Many former isotretinoin 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 Isotretinoin hair-loss happen?
Isotretinoin 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 isotretinoin users attribute aches and joint pains to the acne drug. A 37-year-old nurse with cystic acne claims isotretinoin (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 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.
Accutane (isotretinoin) causes VERY SEVERE BIRTH DEFECTS including:
Severe Internal Defects: defects that you cannot see—involving the brain (including lower IQ scores), heart, glands and nervous system.
Severe External Defects: defects that you can see—such as low-set, deformed or absent ears, wideset eyes, depressed bridge of nose, enlarged
head and small chin.
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.
In small doses amphetamines can banish tiredness and make the user feel alert and refreshed. However, the burst of energy comes at a price. A "speed crash" always follows the high and may leave the person feeling nauseous, irritable, depressed and extremely exhausted. [More]
Although Vyvanse is referred to as “pro-drug” of dextroamphetamine, it's still an amphetamine, meaning that it's easily abused and can cause insomnia, agitation, anxiety and sometimes psychotic symptoms like seeing things or becoming paranoid. [More]
Most people may not know that Strattera (atomoxetine) appears to cause unsatisfactory sexual function (decreased libido, ejaculatory problems and impotence). [More]
Mitchell, S., "Hill committee: Accutane causes suicide." United Press International (UPI), 12/2002.
Meadows, M., "The Power of Accutane: The Benefits and Risks of a Breakthrough Acne Drug." FDA Consumer magazine, 3-4/2001. www.fda.gov/fdac/features/2001/201_acne.html.
Fried, S.M. Bitter Pills: Inside the Hazardous World of Legal Drugs. New York, NY: Bantam Books, 1998.
March of Dimes Fact Sheet, "Accutane and Other Retinoids," rev. 10/05. www.marchofdimes.com/printableArticles/14332_1168.asp.
University of Maryland Medical Center, "Isotrerinoin." American Accreditation HealthCare Commission, 2007. www.umm.edu/altmed/drugs/isotretinoin-073700.htm.
Tirado Sanchez, A, et al. (Nov-Dec 2005). "Erectile dysfunction during isotretinoin therapy". Actas urologicas espa-olas. 29 (10): 974-6. www.ncbi.nlm.nih.gov/pubmed/16447596.
U.S. Environmental Protection Agency, Daughton, C.G. et al., "Special Report: Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?" Environmental Health Perspectives, vol. 107 sup. 6: National Institute of Environmental Health Sciences, 12/99. www.epa.gov/ppcp/pdf/errata.pdf. As reported by the Organic Consumers Association, 07/04. www.organicconsumers.org/bodycare/ppcps.cfm.
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. www.ncbi.nlm.nih.gov/pubmed/15807739.
