Acne and Acne scarring: Is accutane (Isotretinoin) Safe?

Accutane® is the a brand name for isotretinoin, an oral retinoid (Vitamin A) which is used primarily to treat persistent nodular acne and acne scarring. Isotretinoin in any form is available only by prescription from a certified pharmacy. It must be used under the close supervision of a board-certified dermatologist, and is carefully controlled.

HISTORY OF ISOTRETINOIN

Isotretinoin was originally studied and patented in 1969 by Roche Laboratories as a possible treatment for skin cancer. Isotretinoin (also known as 13-cis-retinoic acid) proved to be ineffective for that purpose so was set aside. Then, a decade later, the compound demonstrated surprising success as a treatment for severe acne that was not responsive to other therapies. The drug was subsequently approved by the FDA in 1982 as a treatment for acne and marketed as Accutane. It was a resounding success.  

No other medication has proved to be as effective in treating the ravages of severe nodular acne and cystic acne. Today it’s marketed in the U.S. and worldwide under numerous labels and often unofficially still called Accutane.

HIGHLY EFFECTIVE TREATMENT

Cystic acne is a related condition also involving swelling and inflammation. Pus-filled cysts develop far under the skin as bacteria, oil, and dead skin cells are trapped and block pores. Ranging in size from a pea to a dime, the cysts are painful to the touch and crusty as fluid drains. Permanent scarring can occur if cysts persist.  

The longer breakouts remain uncontrolled, the higher the risk of permanent scarring. This is where isotretinoin/Accutane comes in: if and when you do not respond to topical, oral and/or procedural therapy. Or, if your dermatologist believes that based on the severity of your cystic acne, that time should not be wasted on treatment that will most likely be ineffective.

USING ISOTRETINOIN SAFELY

An absolute no in pregnancy: isotretinoin (or any form of oral retinoid) can cause severe birth defects if taken while pregnant. *Note: isotretinoin does not impact fertility, or the ability to conceive.

Contraception required if sexually active: Women with child-bearing potential must commit to using two forms of effective contraception simultaneously for the duration of isotretinoin therapy, and for the month immediately preceding and a month after treatment. Men taking isotretinoin must use a condom during sexual encounters in case the drug carries over into his female partner via the sperm.

Urine pregnancy tests: Women must have two negative pregnancy tests 30 days apart before starting isotretinoin and a negative test before each prescription is written. Prescriptions are for 30 days only, a new one must be provided each month and filled within 7 days.

Monthly appointments and frequent blood monitoring: Tolerability and treatment response is evaluated at monthly intervals. Commonly monitored blood tests:

• Cholesterol panel: Elevated fat levels in the blood are the most common abnormality expected. Being overweight, having diabetes, a high fat diet and alcohol can worsen the blood fat problems.

• Liver function: Having a liver problem before treatment, being obese, having diabetes and high alcohol intake increases the risk of liver side effects. Avoid alcohol and unnecessary supplements while on isotretinoin.

Database registry: Everyone taking isotretinoin must participate in iPLEDGE, regardless of age or gender.

Must not donate blood

Stop topical acne treatment that you may have been prescribed prior to initiating isotretinoin.

SIDE EFFECTS OF ISOTRETINOIN

The vast majority of patients have no long-term problems and tolerate the treatment quite well. However, there are a number of side effects associated with the use of isotretinoin that patients experience in varying degrees:

• Dryness of the skin especially the lips, eyes and facial skin. Almost everyone gets this side effect. 

• Nose bleeds 

• Eye dryness and irritation are also common. This may be a problem if you wear contact lenses and you may have to wear glasses instead. If you have persistent eye problems even after using eye drops let your Doctor know this. Isotretinoin can also effect your night vision, it is therefore not advisable to drive at night while taking this treatment, especially if you notice that your night vision has been impaired. 

• Some people develop some hair loss which usually recovers. 

• Sun sensitivity

• Some skin bacteria can flourish while on Isotretinoin. Yellowish crusted scabs may be a sign of skin infection and a topical or oral antibiotic may be needed to clear up the problem. A topical antibiotic may need to be put inside your nose to help remove the bacteria.

• Ingrown and irritated nails can occasionally occur. Let your Doctor know if you have nail problems. 

•Muscle aches and pains and joint aches are common especially early in treatment. They tend to improve with time and improve with dose reduction. If you play strenuous sport or weight lifting this may be a problem and you will need to discuss this with your doctor. Gentle exercise is not a problem

•Depression and lethargy can occur especially if you have had depression before. Let your doctor or family know if you feel more depressed, unhappy or moody as the tablet may need to be stopped if depression is a problem. Studies have shown that the level of depression and suicide is higher or similar in people with bad acne without treatment with Isotretinoin.