Accutane

Primary Use

Accutane is specifically indicated for the treatment of severe recalcitrant nodular acne. This type of acne is characterized by many red, swollen, and painful lumps under the skin that are at least 5 millimeters in diameter. Because of the potential for serious side effects, it is typically reserved for cases where other treatments, such as systemic antibiotics or topical medications, have proven ineffective.

When It Is Prescribed

Healthcare providers usually prescribe this medication when acne is:

• Severe and disfiguring.
• Likely to cause permanent physical scarring.
• Resistant to conventional therapies, including oral antibiotics.
• Causing significant psychological distress or social withdrawal.

The goal of treatment is to clear the skin and prevent the formation of new nodules, which helps reduce the risk of long-term scarring.

Mechanism of Action

Accutane belongs to a class of medications known as retinoids, which are derived from vitamin A. It is primarily used to treat severe nodular acne that has not responded to other treatments, such as antibiotics.

Reducing Oil Production

The medication works by targeting the sebaceous glands in the skin. These glands produce sebum, a natural oil. In people with severe acne, these glands often produce excessive amounts of oil, which can lead to clogged pores and the growth of bacteria. Accutane helps to:

• Shrink the size of the oil glands.
• Decrease the total amount of oil the glands produce.

Skin Cell Turnover

In addition to reducing oil, Accutane affects how skin cells develop. It helps the skin renew itself more efficiently, which prevents dead skin cells from building up and blocking the pores. By keeping pores clear and reducing the oily environment where bacteria thrive, the medication helps prevent the formation of painful acne nodules and cysts.

Common Side Effects

Many people taking this medication experience symptoms related to dryness. These common side effects may include:

• Dry skin, lips, eyes, or nose
• Nosebleeds
• Thinning hair
• Dry mouth
• Joint, muscle, or back pain
• Changes in fingernails or toenails

Serious Side Effects

Some side effects can be severe. Contact a healthcare provider immediately if you experience:

• Severe pain in the stomach, chest, or bowels
• Difficulty swallowing or painful swallowing
• New or worsening heartburn
• Vision changes, such as blurred vision or decreased night vision
• Hearing loss or ringing in the ears
• Persistent headache with nausea or vomiting
• Yellowing of the skin or eyes (jaundice)
• Dark-colored urine
• Mood changes, including depression, anxiety, or thoughts of self-harm
• Severe skin rash or peeling on the palms of the hands or soles of the feet

Boxed Warning: Pregnancy Risk

Accutane carries a boxed warning because it causes severe birth defects, premature birth, or fetal death if taken during pregnancy. Because of these risks, the medication is only available through a restricted distribution program called iPLEDGE. Patients who can become pregnant must commit to using two forms of effective contraception and undergo monthly pregnancy testing.

Mental Health Concerns

Serious mental health issues have been reported in patients taking this medication. These include depression, anxiety, psychosis, and suicidal thoughts or actions. Healthcare providers monitor for symptoms such as unusual irritability, loss of interest in activities, or aggressive behavior.

Increased Intracranial Pressure

This medication can cause a dangerous increase in pressure inside the skull, known as pseudotumor cerebri. This condition can lead to permanent vision loss. Symptoms often include severe headache, nausea, vomiting, and blurred vision. Using Accutane with certain antibiotics, such as tetracyclines, may increase this risk.

Internal Organ Damage

• Liver: Potential for liver inflammation and damage. Liver function tests are usually required before and during treatment.
• Pancreas: High levels of triglycerides in the blood can lead to pancreatitis, a serious inflammation of the pancreas.
• Digestive Tract: There is a risk of developing inflammatory bowel disease, which may cause symptoms like severe stomach pain, diarrhea, or rectal bleeding.

Skeletal and Muscular Effects

Some patients experience bone, joint, or muscle pain. There are concerns regarding decreased bone mineral density and the premature closing of growth plates in children and adolescents, which could affect final height.

Vision and Hearing

Vision changes, particularly decreased night vision, may occur and can be permanent. Some patients also report hearing impairment or ringing in the ears.

Pregnancy Risks

Accutane (isotretinoin) is associated with an extremely high risk of severe, life-threatening birth defects if taken during pregnancy. Even a single dose can cause major structural abnormalities affecting a baby's face, brain, heart, and endocrine system. It also increases the risk of miscarriage and premature birth.

Due to these risks, the medication is strictly regulated through a restricted distribution program called iPLEDGE. Requirements for patients who can become pregnant typically include:

• Two negative pregnancy tests before starting treatment.
• Monthly pregnancy tests during treatment.
• A negative pregnancy test one month after the final dose.
• The use of two effective forms of birth control at the same time for at least one month before, during, and for one month after treatment.

Breastfeeding

It is currently unknown whether isotretinoin passes into breast milk. Because of the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended while using this medication. Patients should discuss the timing of breastfeeding with their healthcare provider if they have recently completed treatment.

Available Forms

Accutane (isotretinoin) is supplied as a capsule intended to be taken orally.

Strengths

Depending on the specific prescription, these oral capsules may be available in different strengths, including 10 milligrams (mg).

FDA Approval and Indications

Isotretinoin is FDA-approved for the treatment of severe recalcitrant nodular acne. This indication is reserved for patients who have not responded to standard therapies, such as systemic antibiotics. While the original brand name Accutane was discontinued by the manufacturer in 2009, several generic versions of isotretinoin remain FDA-approved and available on the market.

Boxed Warning and iPLEDGE Program

The FDA requires a boxed warning for isotretinoin because it can cause severe birth defects, miscarriage, and premature birth if taken during pregnancy. Because of these risks, the medication is only available through a restricted distribution program called iPLEDGE, which is a Risk Evaluation and Mitigation Strategy (REMS).

The iPLEDGE program requires the following:

• Registration: All patients, prescribing doctors, and pharmacies must be registered with the program.
• Pregnancy Testing: Patients who can become pregnant must have regular negative pregnancy tests and use two forms of effective contraception.
• Prescription Limits: Prescriptions are limited to a 30-day supply and must be picked up within a specific window of time after a negative pregnancy test is recorded.

Safety Communications

The FDA also monitors and requires warnings for other potential serious side effects, including:

• Psychiatric Concerns: Reports of depression, psychosis, and suicidal thoughts or actions.
• Organ Damage: Potential risks to the liver, pancreas, and intestines, including inflammatory bowel disease.

Manufacturers are required to provide a Medication Guide with every prescription to inform patients of these risks.

Accutane is not intended for weight loss, and significant changes in weight are not a common side effect of the medication. However, some people may experience a loss of appetite while taking this drug, which can lead to weight changes in some cases.

While weight loss is not a primary concern for most patients, there are a few ways the medication might impact a person's weight or eating habits:

• Decreased appetite: Some patients report a reduced desire to eat. If this persists, it may result in unintentional weight loss.
• Stomach and digestive issues: The medication can occasionally cause stomach pain or more serious gastrointestinal problems, which may affect a person's ability or desire to eat normally.
• Dosing requirements: To ensure the body absorbs the medication properly, most versions of isotretinoin must be taken with a meal that contains fat.

If you experience a sudden or significant drop in weight, or if you lose your appetite entirely, you should contact your doctor. These symptoms can sometimes be linked to other side effects that require medical attention.