What are the side effects of oral isotretinoin?

We may not know that oral isotretinoin is considered by many as a very controversial drug because of some of the side effects associated with it (in fact there are congressional hearings and attempts to take it off the market). On the other hand there are also many considered oral isotretinoin treatment to be life saving as no other drug available at this time that can actually treat and often clear those severe, scarring, and disfiguring acne.

Nevertheless, through proper counseling and monitoring, oral isotretinoin can really be a miracle cure for those with severe, scarring acne condition as well as help avoiding the worst side effects that might happen.

Potential Side Effects of Oral Isotretinoin

Common side effects:

1. Dry skin, dry eyes, chapped lips and dry mouth – it is noted that some new formulations of oral isotretinoin are less affected by food and also have fewer side effects in terms of dryness of skin, eyes, and mouth and less of a potential effect on our lipids;
2. Nosebleeds;
3. Muscle aches, backaches, and mild headaches usually at the start of oral isotretinoin therapy;
4. Skin fragility especially on the hands.

Uncommon or serious side effects:

1. Hypertriglyceridemia (liver function abnormalities) – studies show that this can be improved with continued administration of the drug or after oral isotretinoin was stopped; however, regular blood tests are still required to ensure our liver function as normal. What is important is that we should try to avoid drinking alcohol while on this acne therapy as oral isotretinoin is easily metabolized or digested by our liver;
2. Severe headaches;
3. Mood swings/depression/suicidal ideation – though this may be due to different reasons, should this happen, oral isotretinoin should be discontinued in these cases;
4. Pseudotumor cerebri (i.e. increased pressure build-up on the brain);
5. Bone changes (including osteoporosis) - typically found in patients on higher doses of the drug or in whom high doses are used over longer periods of time than usual. Example of this included loss of bone density, bone fractures or delayed healing;
6. Visual changes, e.g. decreased night vision, may last even after oral isotretinoin was stopped.

Most serious but avoidable:

Birth defects – it is very important for any woman who is of child-bearing potential who plans on taking isotretinoin to have two negative pregnancy tests before starting oral isotretinoin treatment and for at least 1 month after the therapy. Adequate contraception is essential, and the importance of this cannot be overstated before and during treatment, and for 4 weeks after discontinuing oral isotretinoin treatment. It is good to know that oral isotretinoin is a potent teratogen that is known to cause birth defects in children whose mothers get pregnant while taking oral isotretinoin or within 1 month after stopping isotretinoin. To know more about “should women continue topical or oral acne treatment while they are pregnant,” we may want to read here.

What dose of isotretinoin is right for me?

As a matter of fact, the dose can vary and depend on our weight and the severity of our acne condition. The doctor will first determine how much we weigh in kilograms and prescribe the dose accordingly. The dose can range from 0.1 to 2 mg/kg, with the most common dose being 0.8 mg/kg/day and divided into two, i.e. morning and night. It is noted that oral isotretinoin is best absorbed and most effective when taken with food and when taken twice a day.

Usually, our doctor will start us on a lower dose for the first month or two so that we can acclimate to the side effects (at least to some extent), and then increase the dose for the rest of the 16 to 20 weeks severe acne treatment course. However, depending on the acne treatment results achieved and in some cases, higher doses for longer than 20 weeks may be required. Also, in some very severe cases of acne, oral prednisone (i.e. a corticosteroid commonly used to treat inflammation), will be given for a duration of 2 to 6 weeks, usually before oral isotretinoin acne treatment is begun.

We may want to know that before we start oral isotretinoin, we should have a detailed discussion with our doctor regarding any concerns that we may have about oral isotretinoin acne treatment, more so if we have any personal or family history of depression. The doctor will give us a booklet that the makers of oral isotretinoin provide; this is for us to review at home and to discuss with our family. Once we have made up our mind, we and our doctor must sign and date on several pages on our next visit. At this pre-oral isotretinoin visit, we are required to have our baseline blood tests, which will be repeated monthly while we are taking the drug.

If we are a woman, the doctor will also review pregnancy and contraceptive issues with us and make sure that we are not pregnant at the start of oral isotretinoin treatment. We have to aware that the risk of birth defects exists while the retinoid is in our body. Once the retinoid is cleared, usually 6 weeks after discontinuing oral isotretinoin acne therapy, there is no longer a risk. Also, patient information form and video are obtainable from the manufacturer to help us better understand on any contraceptive and pregnancy issues.

Why didn't oral isotretinoin work for me?

It is good to know that recurrence of acne is not uncommon after an oral isotretinoin course. However, some people are able to successfully retreated with oral and topical acne antibiotics, benzoyl peroxide, and topical retinoids, though a significant number may require retreatment with isotretinoin. A study conducted showed that, only 38% of patients had no acne at the 3-year follow-up after a single course of oral isotretinoin, while the remaining patients were able to control their acne with topical acne treatment, topical treatment plus oral acne antibiotics, or a retreatment with oral isotretinoin.

The study also showed that relapse was more likely to occur in patients who were 16 years old or younger and in women than in men, and that relapse is most common in the first year after treatment too. From the acne clear and acne care point of views, maintenance acne treatment such as with a topical retinoid may reduce the relapse rate.

How many courses of oral isotretinoin can I take?

To minimize the risk of adverse long-term reactions that oral isotretinoin can have on our bones and other organ systems, we should follow the maximal lifetime dose of oral isotretinoin that is considered safe and appropriate.

In general, most people on a typical course of oral isotretinoin of 0.8 mg/kg for a 16 to 20 weeks’ course could do three treatment courses over their lifetime if necessary. However, the 0.8 mg/kg is considered as an average acne treatment dose, hence dose may be increased in order to get the desired acne treatment results.

Studies show that low-dose oral isotretinoin can still be very effective in some people. This not only minimizes the side effects but also allows us to use it intermittently, over time, as needed and with proper monitoring without concern of reaching the maximal dosage.

Good news is that many of the side effects caused by taking oral isotretinoin are dose related, what that means is that we may work along and within the dose limit given to achieve the desired acne treatment results, and to avoid and minimize those harmful side effects.

Can I have laser or cosmetic treatments, waxing, or other treatments done while I am on oral isotretinoin?

It is learnt that oral isotretinoin (sold under the trade name of Accutane, and its generics is known as Sotret or Amnesty) affects our skin cell turnover, which means that any surgery or laser resurfacing treatment, or even deeper chemical peels when done within 6 months of taking oral isotretinoin can lead to excessive scarring and disfigurement.

In fact, our skin is drier and more sensitive while on oral isotretinoin therapy, as such any treatment that potentially irritates the skin can be a problem. Hence, our skin may react more strongly to waxing or other hair removal methods too.

Nevertheless, with the advent of the newer lasers today, i.e. nonablative lasers, this is probably less of a risk today because they do not remove the upper layers of our skin. Still, many doctors prefer to wait for at least 6 months before doing any elective procedure, especially if it is for cosmetic purposes.

Laser or intense pulsed light hair removal is sometimes done while on oral isotretinoin, but we should be careful to have the procedure done by a qualified doctor and let the doctor know we are on oral isotretinoin.

What should I avoid while taking oral isotretinoin to treat my acne?

The following may come in handy:

1. Women should not get pregnant while taking oral isotretinoin or for at least one month after stopping oral isotretinoin to treat their acne.
   
   
2. Remember not to give blood while taking isotretinoin or for 1 month after stopping it. Studies show that those who are pregnant when exposed to your blood, her baby risks exposure to birth defects.
   
   
3. It is advisable to use 2 forms of contraceptive, i.e. oral contraceptive and a condom while on oral isotretinoin, this is to make sure pregnancy does not occur. Do note that birth control pills that do not contain estrogen (i.e. female sex hormone) may not work while we are on Accutane. Always check with the doctor where appropriate.
   
   
4. Do not take isotretinoin with other antibiotics unless after talking to our doctor.
   
   
5. Do not have cosmetic procedures to smooth our skin (which shall include waxing or laser procedures), while on isotretinoin or for 6 months after we stop.
   
   
6. Never breastfeed while taking isotretinoin or for 1 month after stopping the drug for treating our acne.
   
   
7. Try to avoid excessive sunlight and ultraviolet lights and tanning booths, because oral isotretinoin can make our skin more sensitive to ultraviolet light.
   
   
8. Let our doctor know what other drugs or herbal products that we are currently taking. This is important as some of these products may decrease the efficacy of our oral contraceptive and would have to be discontinued for the duration of our acne treatment and 1 month after.
   
   
9. Avoid vitamin A supplements as they will increase our chances of having side effects.

For other acne clear and acne care questions and soultions, we may want to refer this page here.

When I start oral isotretinoin, will my acne get worse before it gets better?

In some cases, there can be a flare of the acne in the first month after starting oral isotretinoin (sold under the trade name of Accutane, and its generics is known as Sotret or Amnesty). However, to avoid this from happening, we may start a short course of prednisone (i.e. a corticosteroid commonly used to treat inflammation) to minimize the inflammation and to avoid the flare that would accompany it.

In most cases, we should start at a lower dose and incrementally increase the dose over the first one to two months for us to get used to the drug.

Is oral isotretinoin suitable for my acne condition?

It is acknowledged that oral isotretinoin is the first-line treatment for severe acne and may also be used in people who have failed conventional acne treatment, such as through the combination of topical retinoids, benzoyl peroxide, topical or systemic acne antibiotics or where appropriate hormonal acne therapies too.

In general, we may go for oral isotretinoin for our acne condition if we are having:

• Severe nodulocystic acne (i.e. scattered noducles mostly concentrated on our face, chest and our back) or severe acne variants
• Inflammatory acne (i.e. mostly papules, pustules, cysts) with acne scarring consequences that has failed conventional acne treatment
• Moderate-to-severe acne with frequent relapsing
• Acne coupled with severe psychologic distress

To have a better understanding of what is nodules, papules, pustules and cysts, we may want to read “What does acne look like?”

How long is the usual course of oral isotretinoin before I see results?

Studies have shown that most cases of severe acne respond to a single 4 to 6 month treatment course and that the effect of oral isotretinoin, especially for those having severe nodulocystic acne, can be dramatic. It is known that, pustules heal more quickly than papules or nodules (What is papules, nodulocystic and nodules?). Also, lesions on our face, upper arms, and legs tend to respond more quickly than lesions on our back or chest.

Usually, it takes approximately 1 to 2 months after starting oral isotretinoin acne treatment to see real improvement in our acne condition. It is good to know that treatment may start at a lower dose in order for our skin to get used to the drug before increasing to a higher dose in the months that follow.

The result of oral isotretinoin treatment is that we will see fewer or no new lesions, further the lesions that do come up should be smaller and should resolve more quickly. Studies have shown that results tend to last for at least several months to years after stopping this acne treatment.

What follows are the laboratory evaluation procedures that get involved:

Pretreatment evaluation
Review of the side effects
Review of pregnancy/contraception (women only)
Review of informed consent booklet

Blood tests at pretreatment and on weeks 4 and 8
Baseline fasting cholesterol
Triglyceride level
Standard liver function test
Pregnancy test (women only)

Monthly evaluation
Review of the side effects
Review of birth control methods
Physical exam to document improvement
Answer questions and review results

Can I take antibiotics or use other topical acne medications while I am on oral isotretinoin?

The answer is No. This is because oral isotretinoin is recommended to be used only as a monotherapy, meaning that once we start oral isotretinoin we should stop all of our other acne treatments.

If oral isotretinoin is taken in conjunction with the oral tetracycline class of antibiotics, we risk the increased incidence in one of the side effects called pseudotumor cerebri, a condition which make us feel like a really bad, persistent headache, along with nausea, vomiting and problems with vision too.

It is also advisable not to take vitamin A in high doses while on oral isotretinoin therapy because it is in the same class of compounds, and to avoid increased risk of toxicity. In fact, it is uncommon to prescribe other antiacne medications while we are on oral isotretinoin, though some dermatologists co-prescribe a nontetracycline antibiotic such as erythromycin for the first month of therapy.

Because most topical acne treatments are somewhat drying or irritating, we should discontinued them within 1 month of starting oral isotretinoin treatment. Also, topical exfoliating agents, Retin-A, and other drying agents should be avoided as isotretinoin has a drying effect on our skin and mucous membranes.

At the same time it is also helpful to avoid hot showers and drying soaps. It is good to apply moisturizers several times during the day, especially after washing in order to prevent dry, chapped skin. If we are wearing contacts, we may need to switch to soft lenses or eyeglasses until the dryness resolves.

Does oral isotretinoin cure acne?

We need to know that acne is considered as a chronic condition of the skin and is influenced by both genetic and external factors; hence neither oral nor topical acne medications can cure our acne condition. However, the advanced in acne medications does have a profound effect to help us control and treat the acne.

Studies have shown that at least one third of people who have taken oral isotretinoin have a relapse of their acne within the first three years after this oral acne treatment. However, because our sebum and P. acnes levels can increase once the oral isotretinoin treatment is completed, acne can recur in some people after an otherwise very effective treatment course. In cases like this, oral antibiotics or a second treatment course with isotretinoin can be attempted after a 2-month rest period. Rarely, a third course is necessary.

From the acne clear and acne care perspective, should a recurrence of the acne soon after a treatment course is completed, further evaluation is needed to determine whether hormonal influences are a factor, which would then mean that other acne options should be considered either instead of or in addition to oral isotretinoin treatment.

How does isotretinoin work?

Oral isotretinoin is a retinoid preparation that will decrease the size and secretion of the sebaceous glands (i.e. oil-producing glands that are located in the deeper layers of our skin). It works by normalizing our skin cells, especially those lining the pores and prevents the formation of new comedones. It also inhibits the growth of P. acnes (i.e. short for Propionibacterium acnes, the main culprit that is responsible for inflammatory acne) by changing the environment in which the P. acnes usually live and has an anti-inflammatory effect too.

Studies has shown that oral isotretinoin is able to tackle all of the underlying factors behind the process of acne. For example, during oral isotretinoin therapy, our sebum production can be reduced by 90% or more, in a way, this leads to a substantial decrease in the levels of P. acnes. However, both P. acnes and sebum levels will increase once the medication is discontinued.

What is oral isotretinoin?

Oral isotretinoin, which is sold under the trade name of Accutane (if under generics is known as Sotret or Amnesty) is used for severe, scarring acne. With oral isotretinoin scars became a much less frequently observed occurrence.

Isotretinoin is considered by dermatologists as an appropriate treatment for people who have severe nodular acne (i.e. scattered nodules mostly occurred on the face, chest and/or back) or moderate or severe acne that has not responded to oral antibiotics and topical treatment, i.e. for moderate to severe acne that scars physically and psychologically, inflammatory acne that does not respond to conventional therapy and chronic acne that keeps recurring after any given treatment.

However, because of its potential for very serious side effects, this acne treatment is not without its perils and is not for everyone for acne clear and acne care purpose.

Isotretinoin is an oral retinoid which is belong to the vitamin A family of compounds. Hence, many of the side effects that we see from isotretinoin are similar to the effects that we see from taking toxic doses of vitamin A.

Because of the need for this very important drug to continue to be available for the treatment of acne despite its potentially side effects, program and guidelines have been devised to increase the awareness of the risks of oral isotretinoin. For example, one of the requirement is that patients who are taking oral isotretinoin need to enter into a formal registry, in addition to a written consent to be given.