Accutane is a brand name for isotretinoin, a vitamin A derivative used to treat severe cystic acne in those who have failed with other treatments. It is a retinoid and works by decreasing facial oil secretion, thereby drying up and preventing acne breakouts. This medication has been used for years to treat severe acne, often in teenagers, and the side effects can be devastating both at the time and later in life. This article will help shed some light on why isotretinoin is used, what it can be good for, and why you might want to consider another treatment route.
NOTE: Accutane is no longer on the market in the US. However, the manufacturer does have it available in other countries, and the US has multiple generic and brand name options available.
The FDA approved Accutane in 1982 for the treatment of severe acne unresponsive to conventional therapies (this may include topical creams and gels, and oral antibiotics). It was given a pregnancy X category rating, meaning it is completely contraindicated during pregnancy due to devastating birth defects. Two years later, the FDA mandated the company give this medication a black box warning due to the risk of fetal deformity. In the years after, a pregnancy prevention program was put into place in an attempt to ensure that patients were not taking the medication while pregnant. Psychiatric events and suicidal tendencies were also a big deal during this time, and something that the manufacturer and the FDA worked to become more aware of and decrease.
The first generic version of the medication was introduced after Accutane’s patent ran out in 2002, and soon after (in 2005) the iPLEDGE program began. With this program, all patients with a prescription for any version of isotretinoin had to show a negative pregnancy test each month before being able to refill their prescription. Blood work is also required regularly while on this medication due to the potential for organ toxicity. The history of this medication is incredibly rocky, as you can see. However, so many people have been prescribed this medication and have taken it for the treatment of severe acne.
Accutane contains isotretinoin, a retinoid and vitamin A derivative. The dosage is dependent on the condition itself and the weight of the individual. Other brand names for this medication includeAbsorica, Amnesteem, Claravis, Myorisan, Sotret, and Zenatane.
So, is isotretinoin (or any of the branded versions) safe to take? This is all relative, of course. Someone with severe acne that is devastating for their self esteem may say that this medication is absolutely worth any side effect that occurs. However, we know of countless patients who have suffered in the wake of taking this medication years ago, and now have to deal with other conditions that have become impossible to control. We’re talking mostly of dry eye disease, which we’ll get into a bit deeper, but there are other side effects to be aware of as well.
Because isotretinoin effectively works by shrinking the sebaceous glands of the skin, this medication can lead to severe, and sometimes irreversible, dry eye disease. The meibomian glands of the eyelids are sebaceous glands that normally produce healthy oils for the tear film. When these can no longer function, the tears evaporate quickly and the eyes become very dry.
This is a known side effect of Accutane.The medication is secreted into the tears by the lacrimal gland, and is known to induce atrophy of the meibomian glands, which then leads to not only changes in lipid secretion but also increases in tear osmolarity that affect tear film stability. Simply put, this medication can cause issues with both the lacrimal gland system (responsible for the watery portion of your tears) and the meibomian glands (which produce the oil for your tears. It’s a double whammy.In some people, this is not an issue and the damage is mild, however there are many people in which the damage done is permanent and severe. The only way to know if you still have functioning meibomian glands is to have them imaged by your eye doctor. After that, they can give you a plan of attack for treating Accutane induced dry eye disease, and we’ll cover a few options below.
As early as 1982, and possibly earlier, it was known that isotretinoin had the ability to cause birth defects. Many measures were put in place to decrease the chances of someone becoming pregnant while on this medication, and I remember having to go through the process when I considered taking the medication for my cystic acne in high school. I am ever thankful that I decided the side effects were too much of a risk for me, but I know many people are not as lucky.
In order to obtain this medication from the pharmacy, you must present two negative pregnancy tests before your first dose as well as provide a negative pregnancy test before each subsequent monthly refill. Waivers must be signed that you will use two forms of birth control at all times. Breastfeeding while on this medication is also not recommended, as similar medications are known to pass into breast milk and the effects are unknown.
Because isotretinoin affects the sebaceous oil glands of the skin, including the scalp, thinning hair is a very common side effect of this medication. While the drug inserts will state that this is temporary and your hair is likely to grow back after you stop the medication, this is not always the case. Accutane can actually damage the hair follicles, leading to permanent hair loss.
Mental changes due to this medication are common, and many instances of depression, anxiety, and suicidal tendencies have been reported since the medication was introduced in the 1980s. By 2002, there were over 6000 reports to the FDA Adverse Event Reporting System for psychiatric events such as depression and suicidal thoughts. Many of these reports were reports of suicide while using the medication. Since that time, the FDA has worked alongside doctors and pharmacists to decrease the chances of this occurring, screening patients and actively reporting issues such as this.
Dry lips and mouth are incredibly common isotretinoin side effects. It has been recommended by many doctors to use Vaseline, ice chips, sugarless hard candy or gum, and saliva substitutes to decrease the effects of the medication while using it. However, it’s likely better to prevent the issue in the first place! Accutane affects the oil glands and while it can affect the skin anywhere on the body, it often has a greater effect on the lips because of their very high cellular turnover rate. The same can be said for the eyes as well!
Headaches are possible on isotretinoin, and if they are persistent it’s important to talk with your doctor about discontinuation right away. Although rare, Accutane is a cause of pseudotumor cerebri (PTC) or idiopathic intracranial hypertension. This condition occurs when the pressure on the brain elevates, leading to a headache, blurred vision, and ringing in the ears. The eye doctor is often the first person to diagnose this condition, as the optic nerve can be seen to swell on evaluation. While it’s most common in obese patients and those of childbearing age, it can occur in anyone while on this medication. It is important to discontinue the medication before further damage to the optic nerve (vision) and brain are done.
Another common side effect of Accutane use is joint and muscle pain, and this side effect may be permanent. This may be noted most when waking up in the morning with a stiff neck, and those who play contact sports may need to cut back while on this medication. It’s also known to stunt long bone growth in teens, so it should be used with caution in these individuals.
Treating dry eye disease after the use of this medication can present quite a challenge for the doctor, much to the frustration of the patient. Because Accutane has the potential to affect both the lacrimal and the meibomian glands responsible for producing normal, healthy tears, treatment must be multifaceted.
First of all, ensure that your diet is top notch and full of plants! By decreasing inflammation overall in your body, you can help your glands produce healthy oil. Even if you only have a few meibomian glands left, this just increases the importance of a healthy diet. Get rid of the junk food, fried foods, food that comes in a box with a million ingredients, and added sugar. Check out this blog for more information on where to start (hint: it has to do with green smoothies).
In addition to an overall healthy diet, increase your intake of triglyceride based omega-3 supplements. While it is often best to get omega-3s through food, it is sometimes not possible for everyone to eat wild caught (vs. farm raised) fish, and some people do not enjoy fish. For those people, we recommend omega-3 supplementation. Studies have shown that a ratio of 3:1 EPA:DHA is beneficial for dry eye disease.
Next, adopt an eyelid hygiene routine. You can find my exact routine here, but here are the basics:
There is some research beginning to show that LipiFlow may have the potential to reverse meibomian gland atrophy, so this is promising. I know that the same type of research will soon be happening for Intense Pulsed Light (IPL) as well, and both may soon show benefits for those with meibomian gland atrophy.
With the discussion of dry eye disease often comes the discussion of eye drops, or artificial tears. For those with lipid layer deficiencies due to MGD, we often recommend preservative free lipid based tears. We usually recommend using them up to four times daily, although if they’re preservative free you can technically use them as needed. Here are a few of our favorite eye drops:
We’re a big fan of these eye drops and the company that manufactures them. Available only through your eye doctor, Oasis Tears Plus PF is a great choice for anyone with dry eye disease.These drops work to lubricate, moisten and relieve delicate eye tissue from irritation and dryness. Oasis Tears is a true solution that keeps tears on the eye surface to relieve the irritation and gritty sensation that is commonly experienced with dry eyes.
Ingredients: Glycerin (0.22%), sodium chloride, sodium hyaluronate, sodium phosphate dibasic, sodium phosphate monobasic, water
This is another one we’ve used for years in our practices, and it’s a drop that works quite well for patients.Retaine MGD is a revolutionary preservative-free ophthalmic emulsion (meaning, you have to shake it before use) that moisturizes, lubricates and protects moderate to severe dry eyes. It is a milky white eye drop, so don’t be alarmed! It is a proprietary cationic oil emulsion technology that effectively delivers ingredients to the ocular surface.
Active Ingredients: Light Mineral Oil (0.5%) Mineral Oil (0.5%)
Inactive Ingredients: Cetalkonium chloride, glycerol, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection
This artificial tear has been around awhile and is still a great option. It soothes dry eyes with an innovative triple-action formula that relieves common symptoms like burning, irritation, blurred vision, and grittiness. Refresh Optive Advanced Preservative-Free works on all three layers of the tear film to: 1. Lubricate; 2. Hydrate the surface cells of the eye; 3. Protect and help reduce tear evaporation. Shaking is not required.
Carboxymethylcellulose sodium 0.5%, Glycerin 1%, and Polysorbate 80 0.5%.
Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide
This is the only artificial tear made with a blend of natural oils, and it contains flaxseed and castor oils. These natural oils help fortify and restore the lipid layer of the tear film, which prevents tear evaporation when working properly. We like this new artificial tear because it helps nourish and protect all three layers of the tear film which can potentially be damaged by dry eye disease, and it contains omegas. This choice does not require shaking before use.
Ingredients: Carboxymethylcellulose sodium 0.5%, Glycerin 1%, Polysorbate 80 0.5%,boric acid; butylated hydroxyl toluene; castor oil; erythritol; flaxseed oil; levocarnitine; pemulen tr-2; polyoxyl 40 stearate; purified water; trehalose
Systane Balance eye drops use clinical strength, intensive therapy to help relieve dry eyes. They really do work well to give you comfort that lasts. The only thing we don’t love about this choice is that it’s not preservative free, so we believe there are better options (above). However, this has been a mainstay lipid based artificial tear for years now. The restorative formula helps to restore the lipid layer of the tear film and replenishes essential moisture needed for it to function. If choosing this option, make sure you’re not using it more than four times per day due to the preservatives.
Active Ingredients: Propylene Glycol 0.6%
Inactive Ingredients: Boric Acid, Dimyristoyl Phosphatidylglycerol, Edetate Disodium, Hydroxypropyl Guar, Mineral Oil, Polyoxyl 40 Stearate, Polyquad® (Polyquaternium-1) 0.001 Preservative, Sorbitan Tristearate, Sorbitol and Purified Water.
Accutane can be dangerous if the proper protocols are not followed. For example, high doses of vitamin A (which is essentially what Accutane is) can cause birth defects in babies born to mothers who take the medication while pregnant. In addition to this, isotretinoin increases the level of some fats in the bloodstream, which can be dangerous. It also may affect the liver, and for these reasons patients on Accutane (or other similar medications) must have blood work completed regularly while taking it.
The safety of Accutane is a question that patients considering this medication should look into. When all safety protocols are followed, the FDA has deemed isotretinoin safe for use in those suffering from severe acne. That being said, this medication has so many side effects, and some of them can be quite serious both while taking the medication and for years afterward (dry eye disease is an example of this). Make sure to discuss all side effects with your doctor to determine whether or not this medication is appropriate for you.
Increased cholesterol, joint and muscle issues, organ damage, vision and other eye problems (such as dry eye disease). All of these conditions may be permanent, although not everyone will suffer from these.
Accutane was discontinued in the United States in 2009 because it was found to potentially cause inflammatory bowel disease (IBD).
Although weight gain is listed as a side effect of isotretinoin, small studies have failed to show a major correlation here, and many of the conclusions they’ve come to are conflicting. The medication can cause serum levels of cholesterol to increase, and one study showed that adiponectin and leptin levels were increased while on Accutane. Both of these play a role in hunger and feeding.
This medication has the ability to cause thinning hair and hair loss because it shrinks the sebaceous glands of the scalp and may damage hair follicles. This side effect is incredibly common in Accutane users, although it is usually reversible once off the medication (once your hair has time to grow back).
In many cases, isotretinoin offers a permanent reduction in acne for the patients who use it. Occasionally, some people may need more than one round of treatment to get this effect, but the vast majority see benefits. If you’re considering taking this medication, ensure that you discuss all side effects and protocols with your dermatologist before beginning.
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