Oral isotretinoin

Isotretinoin capsules (e.g. Oratane, Roaccutane) are the most effective treatment for severe acne as they address all the known causes of severe cystic acne. They are a type of retinoid and work by unblocking and preventing further blockage of pores, reducing sebum or oil production and soothing the redness and inflammation of acne. This treatment makes the oil gland less friendly to the bacteria that contribute to acne.

Isotretinoin capsules produce a long-term remission in up to 85% of people with severe cystic acne. Some people can have long lasting acne clearance from just one course of oral isotretinoin treatment (typically at normal dose five to six months duration or at low dose 10-12 months). However, a small percentage of people can have a recurrence of their acne, which is usually less severe than their original form and may occur after a long break from having pimples. Depending on the severity of the recurrence, another course of isotretinoin may help. 

Isotretinoin is available on the Pharmaceutical Benefits Scheme (PBS) for treating severe cystic acne that hasn’t responded to other treatments. It’s available in a variety of doses from 5-40 mg. The newer, low dose isotretinoin provides a useful starting point for patients who are particularly concerned about the risk of side effects.

Generally, only skin specialists can prescribe oral isotretinoin, so you will need a referral to a dermatologist for careful assessment and monitoring. 

Before you start on isotretinoin capsules your doctor may run a few tests such as:

  • Blood tests looking at blood fats (cholesterol and triglycerides), liver function, a blood count and some hormone tests
  • Pregnancy tests 

Potential side effects

Although retinoids, such as isotretinoin, are very effective at treating acne they can cause side effects.  It's important to have regular check-ups with your prescribing doctor because they can tailor your therapy and give you more information on how to manage or prevent side effects.  If your doctor has recommended Oratane, a patient support pack including a cleanser, lip balm and moisturiser is provided when you receive your prescription.

Dryness

Retinoids work by reducing the size of the sebaceous glands and the amount of oil they produce. So, one of the most common side effects is dryness, scaliness or skin irritation. This can be reduced by taking precautions such as washing with a gentle soap-free cleanser and using an oil-free non-comedogenic moisturiser (preferably with sunscreen SPF 30). 

Isotretinoin, will make your skin much drier in the first few weeks of treatment. To help protect your skin, try to keep your showers shorter than two minutes and use lukewarm water rather than hot. Using a moisturiser on your face regularly will help keep the dryness under control. The best type of moisturiser is an oil-free face moisturiser for sensitive skin. 

People taking isotretinoin capsules commonly find their lips are particularly dry and may need to use a lip balm containing sunscreen frequently. Dryness of the throat, nose (nosebleeds may occur) and eyes are also potential side effects which can be helped by eye drops and applying a soft petroleum jelly (e.g. Vaseline) just inside the nostrils. 

Dryness may be worse when you’re in air conditioning or a low humidity climate. If you wear contact lenses, you may also find it difficult to tolerate the lenses with higher doses of isotretinoin due to dryness. Eye drops (e.g. Thera tears) may be helpful.

Men with severe acne who shave should try both an electric and safety razor to see which is more comfortable. If you use a razor, soften your beard thoroughly with soap and warm water or you may want to shave using a moisturiser rather than a shaving cream or soap. To avoid nicking pimples, shave as lightly as possible. Shave only when necessary and always use a sharp blade.

Patients prone to eczema may need to increase moisturising their skin to prevent any flareup of their eczema.

Be aware that ss your skin is more sensitive and fragile, minor skin trauma can be slower to heal such as cuts and grazes especially when playing sport. 

Flare-ups

When you take isotretinoin capsules or use retinoid creams or gels, it’s important to be aware that although this is the most effective acne treatment, your acne may get worse about three weeks in. An antibiotic or anti-inflammatory may be prescribed in conjunction to try and prevent this. Don't give up!  

Some patients experience an initial flare-up which is minimised by starting on a lower daily dose.  With continued therapy, acne flares generally become less severe, less frequent and shorter in duration, and in most cases the acne improves. If you are concerned about a flare-up in your acne after starting a new acne therapy you can contact your prescribing doctor for advice. 

Sun sensitivity

Retinoids make skin more easily irritated by sun, wind and water. Increased sun sensitivity leading to quicker sunburn is common in Australia, particularly in spring and summer. It’s important to take extra sun protection measures such as wearing sunscreen, a broad-brimmed hat, protective clothing and trying to stay in the shade. 

Many people who take isotretinoin capsules can use an oil-free, SPF50+ broad-spectrum water resistant sunscreen without it worsening their acne. 

It’s a good idea to check the UV Index via news reports, weather updates or websites before you head outside.

Joint aches

Tiredness, muscular, joint aches and pains are not common side effects, but they can occur. 

Generally these side effects are dependent on the number of capsules you’re taking per day. If these side effects become severe and unmanageable, reducing the dose you take each day may help. However, this may also prolong your course of capsules. 

Rare side effects

These include hair loss, mood change, severe headaches associated with nausea, vomiting and vision changes may occur. If any of these symptoms occur, stop therapy and contact your doctor or dermatologist. 

People with a family history of high cholesterol or triglycerides are at risk of having these blood fats increase while on isotretinoin treatment. A repeat blood test is usually done after a month or so after starting isotretinoin therapy to recheck these tests. It’s a good idea to avoid alcohol while you’re taking the capsules. 

Important precautions for women considering oral isotretinoin

If you are a woman of child-bearing age (when periods start) wanting to start a course of prescribed isotretinoin for acne treatment, you (and your family) need to understand the risks involved. 

Birth defects can be caused if you: 

  • Take oral isotretinoin while you’re pregnant
  • Become pregnant while taking oral isotretinoin
  • Become pregnant within one month of stop taking oral isotretinoin

As a result of these risks, you must use strict birth control for: 

  • At least one month before you start isotretinoin treatment
  • During the entire isotretinoin treatment
  • For at least one month after you stop taking the isotretinoin treatment

To avoid pregnancy while on the drug and for one full reproductive cycle after treatment, you need to use very effective contraceptive measures. Using two effective forms of birth control (such as the oral contraceptive pill and use of a condom) is recommended because even the oral contraceptive pill occasionally fails. 

There are many issues involved in choosing and taking the oral contraceptive pill, such as the importance of taking the pill at the same time each day. 

Irrespective of what contraceptive measures you choose, a negative pregnancy test is usually required before starting isotretinoin.  This will be taken just before starting isotretinoin.  You then need to wait until the second or third day of your next menstrual period before you start taking isotretinoin. This is an extra check to make sure you are not pregnant.

Anyone concerned that they have become pregnant while on isotretinoin should contact their doctor and dermatologist immediately. 

You can call the Medicines Line on 1300 633 424 and the following state-based services are also available:

State Organisation Phone
NSW MotherSafe Royal Hospital for Women, Randwick

02 9382 6539 (metro residents)

1800 647 848 (non-metro residents)

ACT Drug Information, Canberra Hospital

02 8382 2136

SA Women and Children's Hospital, Adelaide

08 8161 7222

VIC

Medicines Information Service, Royal Women's Hospital

Medicines Information Centre, Monash Medical Centre

03 8345 3190

03 9594 2361

WA Women's and Children's Health Services, Perth

08 9340 2723

 An emergency oral contraceptive pill is available from hospital emergency departments and over-the-counter at pharmacies. It must be taken within 72 hours after unprotected sex to be effective. It's best to see a doctor to discuss the options that are available. 

A dermatologist will provide information on pregnancy prevention strategies. For more information on contraceptive options, contact a local doctor or family planning association. 

Isotretinoin does not affect your fertility in the long-term. 

If you are thinking about becoming pregnant after using oral isotretinoin, it is safe to conceive one month after all capsules are finished.

Isotretinoin and mood disorders

It's understandable that young people with acne may feel unhappy and consequently may develop mood disorders, such as depression, because of their appearance. So, it's no surprise to find many studies that show acne can cause depression. As a result, it is very important that the effects of treatment on depression also be studied. 

There are several comprehensive studies by scientific experts and worldwide regulatory authorities, such as the Food and Drug Administration (FDA) in the United States, that have not found a definite link between isotretinoin and depression or suicide. 

In fact, studies suggest that the risk of depression is reduced in those with severe acne being treated with isotretinoin. This is because isotretinoin improves acne and can therefore improve an individual's overall feeling of well-being. 

If you have a history of depression and/or a family member with depression and isotretinoin is being considered, make sure you discuss this with your doctor so they can monitor your mood more closely. 

There have been reports of depression and suicide in people taking isotretinoin and there are many possible reasons for this. 

Both severe acne and newly diagnosed depression particularly affect teenagers and young adults. Although studies suggest isotretinoin does not cause depression and there is no link, it is very important to monitor everyone on therapy for severe acne for depression and suicide risk, including those being treated with isotretinoin. 

Therapy will usually be stopped due to the possibility of an idiosyncratic reaction or intolerance to isotretinoin. Idiosyncratic reactions to medications are usually rare and the reasons for them are not understood or predicted by pre-treatment investigation.