Isotretinoin (Roaccutane)

We look at everything you need to know if you’ve been prescribed isotretinoin, a vitamin A derivative for severe acne, or the branded version Roaccutane  

What is isotretinoin used for?

• Severe acne.

Isotretinoin (brand name Roaccutane) can have serious side effects and its use must be supervised by a dermatologist. It’s reserved for treating severe acne (such as nodular or conglobate acne or acne at risk of permanent scarring) that hasn’t improved with standard treatment involving oral antibiotics and topical medicines.

How does isotretinoin work?

Isotretinoin belongs to a group of medicines known as retinoids, which are derivatives of vitamin A. Isotretinoin taken by mouth works by reducing the production of the skin’s natural oil (sebum).

Acne occurs due to an excessive production of sebum from over-active sebaceous glands in the skin. The sebum blocks the sebaceous glands, which prevents the oil from flowing freely out and causes an accumulation of sebum under the skin. The bacteria associated with acne thrive in these conditions. They feed on the sebum, and produce waste products and fatty acids that irritate the sebaceous glands, making them inflamed and causing spots.

Isotretinoin decreases the size and activity of the sebaceous glands in the skin, which reduces the amount of sebum that is produced. This stops the glands becoming blocked, and means bacteria are less likely to thrive. It also reduces the inflammation in the skin.

How long does isotretinoin take to work?

Your acne may get worse when you first start taking isotretinoin, but this usually improves within 7 to 10 days of continued treatment. In most cases, complete or near-complete clearing of acne is achieved with a 16 to 24 week course of treatment, and you’re then likely to remain free of acne for a long time. Repeat courses are not normally recommended, unless a definite relapse is seen after treatment is stopped. Repeat courses should not be started until at least eight weeks after stopping treatment, as your acne may still improve in this time.

How do I take isotretinoin?

• The isotretinoin dose prescribed and how often to take it varies from person to person. Always follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the medicine.
• Isotretinoin capsules are usually taken once or twice a day. The capsules should be swallowed whole with a drink, either with or just after food (on a full stomach).
• If you forget to take a dose take it as soon as you remember, unless it’s nearly time for your next dose. In this case just leave out the missed dose and take your next dose as usual when it’s due. Do not take a double dose to make up for a missed dose.

What should I know before taking isotretinoin?

• Isotretinoin causes major birth defects (serious malformations of a developing foetus) if taken during pregnancy and there are some strict rules to avoid a developing baby being accidentally exposed to it. Your doctor will not prescribe this medicine to women who could get pregnant, unless the following conditions of the Pregnancy Prevention Programme are met:
  • Women must use at least one, but preferably two (for example the pill and condoms), effective methods of contraception at all times to prevent pregnancy.
  • Contraception must start at least four weeks before starting treatment, be used at all times during treatment and for at least four weeks after stopping isotretinoin, even if you don’t have a period.
  • Your doctor can’t prescribe isotretinoin until you have been using effective contraception for at least a month and have had a negative pregnancy test.
  • Your doctor is only allowed to prescribe 30 days supply of isotretinoin at a time, and the prescription will only be valid for seven days.
  • You will need to have a follow-up visit every month, at which you will have to have a pregnancy test that must come back negative before a new prescription can be issued.
  • Five weeks after stopping treatment you should have a final pregnancy test to make sure you have not fallen pregnant. If you think there is a chance you could be pregnant, either during treatment, or in the first month after stopping treatment, you must consult your doctor immediately.
• There is no evidence to suggest that children fathered by men who are taking isotretinoin will be affected by the medicine, but men should remember not to share this medicine with anyone, particularly females.
• You should never give isotretinoin to another person and you should return any unused medicine to your pharmacist at the end of treatment.
• People taking isotretinoin must not donate blood during treatment, and for at least four weeks after stopping treatment. This is due to the potential risk of the medicine to an unborn child if a transfusion of your blood was given to a pregnant woman.
• Avoid exposing your skin to intense sunlight or UV light while taking isotretinoin. Use a sunscreen of at least SPF 15 even on a bright but cloudy day. Do not use sunbeds.
• Isotretinoin is likely to make your skin and lips very dry, so it’s recommended that you use a moisturiser and lip balm from the start of treatment.
• Avoid waxing any part of your body while taking isotretinoin, and for at least six months after stopping treatment, as this could strip the top layer of skin. Chemical dermabrasion and cutaneous laser treatment should also be avoided during treatment and for five to six months after stopping isotretinoin, as this could cause scarring.
• Isotretinoin can make your eyes dry. This can be relieved with artificial tear drops. Ask your doctor or pharmacist for advice. If you wear contact lenses you may find that they become uncomfortable during treatment and you have to wear glasses instead.
• Decreased night vision may also occur during treatment and after stopping isotretinoin, and can occur suddenly. For this reason you are advised to be cautious when driving or operating any vehicle at night. If you experience any visual difficulties, inform your doctor so that your vision can be monitored. It may sometimes be necessary to stop treatment.
• It’s usually fine to drink alcohol within recommended guidelines while you’re taking isotretinoin, although do always check this with your doctor first.
• Isotretinoin may rarely cause depression, anxiety, aggression and mood changesand very rarely psychotic symptoms (eg delusions or hallucinations) and thoughts of suicide or suicide attempts. Make sure your doctor knows if you have ever suffered from depression. If you start to feel depressed, or experience any other changes in your mood or behaviour during treatment, it is very important to talk to your doctor straight away.

What other monitoring do I need while taking isotretinoin?

• You will need to have blood tests to monitor your liver function and the amount of lipids (fats such as cholesterol and triglycerides) in your blood before you start treatment with isotretinoin, one month after starting and then at further three-monthly intervals.
• Isotretinoin may increase your blood sugar level. Your doctor may want to monitor your blood sugar level if you are overweight, have diabetes or suffer from alcoholism.

Who shouldn’t take isotretinoin?

• Women who are pregnant or breastfeeding.
• Woman who could get pregnant, unless all the criteria described above are met.
• Children under 12 years of age, and children with acne that has developed before reaching puberty.
• People with liver problems.
• People with high levels of fats (lipids) such as cholesterol and triglycerides in their blood (hyperlipidaemia).
• People with a condition resulting from the excessive consumption of vitamin A (hypervitaminosis A).
• People taking tetracycline-type antibiotics.
• People who are allergic to any of the ingredients. Check the ingredients listed in the leaflet that comes with the medicine if you know you have specific allergies or intolerances.

What are the possible side effects of isotretinoin?

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with isotretinoin. Just because a side effect is stated here doesn’t mean that all people taking isotretinoin will experience that or any side effect.

Very common (affect more than 1 in 10 people)

• Dry skin (causing inflammation, peeling, itching, increased skin fragility – see warnings above).
• Dry, inflamed and cracked lips.
• Dry eyes (causing eye irritation, conjunctivitis or inflammation of the eyelids – see warnings above).
• Pain in the muscles and joints, particularly in adolescents. You should minimise the amount of vigorous physical activity you do while taking isotretinoin.
• Anaemia.
• Changes in the numbers of blood cells called platelets in the blood.
• Increased level of fats called triglycerides in the blood.
• Increased liver enzymes.

Common (affect between 1 in 10 and 1 in 100 people)

• Dryness of the lining of the nose (causing nasal inflammation and nosebleeds).
• Headache.
• Decreased numbers of white blood cells in the blood.
• Increased levels of sugar and cholesterol in the blood.
• Presence of blood or protein in the urine.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Mood changes, anxiety, aggressive tendencies or depression (see warning above).
• Hair loss (alopecia).
• Allergic reactions.

Very rare (affect fewer than 1 in 10,000 people)

• Increased sensitivity of the skin to UV light (photosensitivity – see warning above).
• Increased pigmentation in the skin.
• Increased sweating.
• Visual disturbances (eg blurred vision, cataracts, colour blindness, decreased night vision, dislike of light). See warning above.
• Inflammation of the surface of the eye (keratitis).
• Hearing problems.
• Dry throat, hoarseness.
• Swollen glands.
• Diabetes.
• Convulsions.
• Drowsiness.
• Dizziness.
• Abnormal behaviour, psychotic disorders, eg with delusions or hallucinations, or suicidal feelings or thoughts. See warning above.
• Raised pressure inside the skull, called benign intracranial hypertension. Stop taking isotretinoin and consult a doctor immediately if you experience a severe headache, together with nausea, vomiting and visual disturbances while taking it.
• Breathing difficulties due to a narrowing of the airways (bronchospasm, particularly in people with asthma).
• Inflammatory bowel disease. Stop taking isotretinoin and consult your doctor straight away if you get severe diarrhoea, particularly if it contains blood, during treatment.
• Inflammation of the pancreas (pancreatitis), liver (hepatitis) or kidneys (glomerulonephritis).
• Bone disorders such as arthritis, increased growth of bone, reduced bone density, or calcification of tendons or ligaments.
• Inflammation of tendons (tendonitis).

Isotretinoin has been associated with causing some severe, potentially life-threatening skin reactions that require immediate medical treatment. It’s important to stop taking isotretinoin and consult your doctor immediately if you develop a skin rash or other related symptoms during treatment. These types of skin rash appear initially as circular patches, often with central blisters usually on arms and hands or legs and feet. More severe rashes may include blistering of the chest and back. Additional symptoms such as eye infections (conjunctivitis) or ulcers of the mouth, throat or nose may occur. Severe forms of rash may progress to widespread peeling of the skin which can be life-threatening. These serious skin rashes are often preceded by headache, fever and body aches (flu-like symptoms).

Talk to your doctor, nurse or pharmacist if you want any more information about the possible side effects of isotretinoin. If you think you have experienced a side effect, did you know you can report this using the yellow card website?

Can I take other medicines with isotretinoin?

It’s important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with isotretinoin. Similarly, check with your doctor or pharmacist before taking any new medicines with isotretinoin, to make sure that the combination is safe.

Tetracycline-type antibiotics, eg minocycline, doxycycline, tetracycline, must not be taken with isotretinoin.

Do not take vitamin A supplements (including multivitamins containing vitamin A) while you’re taking isotretinoin, as this may result in a condition similar to vitamin A overdose, which may cause changes in the structure of the bone.

Other treatments conventionally used for acne, including antibiotics, exfoliants, medicines which loosen the dead skin on the skin surface (keratolytics), or radiation therapy with ultraviolet light (PUVA), should be avoided while taking isotretinoin. However, non-irritant preparations can be applied to the skin if necessary and it’s fine to use moisturisers.