Accutane Overview

Considered the most significant breakthrough in acne drug treatment over the last two decades, Isotretinoin (trade name Accutane) is the only drug that has the potential to clear severe acne permanently after one course of treatment. One course, typically lasting five months, results in prolonged remission of acne in up to 85 percent of patients. A member of a class of drugs known as retinoids, Accutane is highly effective, but does not work for everyone and severe side effects can accompany the treatments.

Dermatologists use Accutane to treat a type of severe acne (nodular acne) for which other treatments, including antibiotics, have failed. Researchers and doctors have discovered that, despites its success in treating severe acne, Accutane can cause serious side effects. Most notably, the side effects of taking Accutane include mental disorders and birth defects.

The United States Food and Drug Administration (FDA) approved Accutane in 1982. Since then, doctors have treated about 5 million people in the United States and 12 million worldwide, according to its manufacturer, Hoffmann-La Roche. Since its introduction, the number of patients taking Accutane has continued to increase, with about half the patients being females, most of who are in their childbearing years (age 15-44). Because of concern about the drug's risks, FDA closely monitors and continues to evaluate Accutane.

As powerful as Accutane can be in improving patients' lives, its adverse effects can be just as powerful. 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, including depression. More rarely, patients have developed suicidal behavior and killed themselves.

While taking Accutane or soon after stopping Accutane, some patients have reported experiencing depression or other serious mental problems. Symptoms of mental problems that Accutane users experience include sadness, anxiety, irritability, anger, loss of pleasure or interest in social or sports activities, insomnia, changes in weight or appetite, deterioration of school or work performance. In extreme cases, patients taking Accutane have exhibited suicidal tendencies, which have on occasion resulted in suicide or attempted suicide

Accutane can also cause birth defects, miscarriages, premature birth, or stillbirth if a woman takes the medication during pregnancy. La Roche, the FDA, as well as physicians all caution women against using Accutane if they are pregnant or plan to become pregnant. In addition, a woman should wait at least a month after discontinuing Accutane before getting pregnant.

What is Accutane?

La Roche developed the oral drug Accutane to treat the most severe form of acne. While other medications often fail to prevent the development of disfiguring acne, Accutance has proven powerful against nodular acne. Though it has demonstrated useful for those suffering from severe acne, because Accutane can also have dramatic side effects, the FDA has laid out strict precautions for its use.

Accutane has a wide range of possible side effects, varying from the mildly inconvenient to the very traumatic. Accutane users commonly experience dry or fragile skin, dry or cracked lips, dry mouth, dry nose, itching, peeling palms or soles, rash, skin infections, sunburn-sensitive skin, thinning hair, decreased tolerance to contact lenses, trouble regulating the blood sugar level, fatigue, delay in wound healing, sudden decrease in night vision, bone or joint pains, nosebleed, conjunctivitis ("pinkeye") or other eye inflammation, nausea and vomiting, headache, chest pain, and bowel inflammation and pain, stomach and intestinal discomfort, urinary discomfort. More uncommonly, but more severe side effects include, birth defects ­ including mental retardation and physical malformations ­ and fetal death, depression, psychosis (with effects such as delusions, hallucinations, difficulty in the thinking process, and trouble with judgment and insight), suicidal ideation, suicide attempts and suicide, and intracranial hypertension.

The severe side effects associated with Accutane cause doctors to use restraint in prescribing the drug. Doctors normally use it as a last resort after all other medications have failed. Beyond the infrequency with which doctors prescribe Accutane, they also use care in determining the dosage, which they base on the patient's body weight. In addition, the risk of birth defects has led the FDA and La Roche to develop a program designed specifically for women to complete prior to treatment. Women must be counseled on pregnancy prevention and must complete pregnancy tests before and during treatment in order to receive the drug.

The Use of Accutane

Accutane is a powerful drug used in the treatment of acne. Four to five months of Accutane treatment usually leads to clearing of acne for one year or more after a patient discontinues treatment. Most other acne-controlling medicines consist of antibacterial agents, which require daily dosages to effectively treat acne.

Accutane decreases the amount of oil the skin's sebaceous glands produce. Often in the first few months of treatment, acne worsens and side effects, such as lip dryness begin. Obvious skin improvement can take as long as two months after a patient begins treatment.

Accutane does not represent a permanent cure for acne, although it often provides relief and prevents disfiguring until the time that the acne clears up naturally. Researchers have found that a patient's skin may stay clear for months, even years, after discontinuing Accutane. In about one person out of ten, acne returns after one year. About one person in four suffers a reoccurrence of acne after two years. If acne returns, antibiotics may work, or doctors may again attempts treatment with Accutane.

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