Introduction and History

Accutane (isotretinoin) is an oral acne medication that has been used in the United States since 1982. It is a synthetic retinoid and closely related to Vitamin A. Accutane is dramatically effective for all types of acne, including severe scarring cystic acne. There is simply no better treatment for acne!

Before Accutane became available, dermatologists had no consistently effective treatment for the severe forms of acne. Despite the use of sulfa medicines, freezing therapy, ultraviolet light, x-ray therapy, surgery, and high doses of various antibiotics, severe acne would frequently continue for years unabated. Patients would suffer with painful cysts that would produce scars and severe psychological problems, despite the best therapies and intentions available.

Accutane has dramatically changed all that. Over the last two decades, millions of people all over the world have successfully and safely used Accutane to clear their resistant acne. Perhaps more importantly, Accutane has converted thousands of reclusive and very unhappy patients with unsightly faces, into clear-skinned and self-confident individuals. Accutane is not just a face-saver; it can also be a true "life changer" .

The New FDA Mandated Medication Guide

Because of the FDA‚s increasing concern over potential severe side effects, a new Accutane medication guide was produced and distributed by the manufacturer in January 2001. The FDA and the drug manufacturer (Roche Laboratories) have directed that all patients who are to receive Accutane must be given this guide. The FDA has also mandated that pharmacists provide this Accutane information sheet every time an Accutane prescription is filled or refilled. The FDA, the drug manufacturer, and all dermatologists want to be sure that every patient who is placed on Accutane understands all of the drug's potential side effects.

I have read the new Accutane medication guide issued by the manufacturer and I feel it covers the main risks quite thoroughly. I am, however, concerned that it raises excessive fears about other risks that are either extremely rare or are simply not related to Accutane. I am also worried that patients, or their families, who read this new medication guide may conclude that Accutane is a terribly dangerous drug. This is simply not the case. Because of fears that may be generated by the Medication Guide, parents may refuse to allow the drug to be used when it is really indicated. I fear that some of some of my patients will be forced to endure years of painful acne with resultant facial and psychological scarring because of unwarranted fears over potential rare Accutane side effects!

Our Perspective

For most patients who have treatment-resistant acne, and who understand the risks and agree to follow the rules, I will be very happy to prescribe this excellent medication. My goal as a dermatologist is to clear, and if possible, to cure, skin diseases as quickly, safely, and efficiently as possible. I do not want my patients to be denied the use of an excellent medication because of unrealistic and exaggerated fears.

So what are the Real Risks of Accutane?

Pregnancy and Fetal Abnormalities

For fertile female patients ("of child bearing age"), the most serious and feared side effect of Accutane by far has to do with the drug's teratogenic potential: it can definitely cause very serious birth defects in a developing fetus. The birth defects occur in the first few weeks after conception if the embryo/ fetus is exposed to any amount of Accutane. This period is often before the woman even recognizes that she is pregnant. Therefore it is mandatory that every fertile woman anticipating Accutane usage must take measures to absolutely insure that she will not be pregnant for one month prior to the start of Accutane therapy, and that she will not conceive while on the treatment, or for one month after the treatment. Two forms of contraception must be used simultaneously. Accutane gets out of the body just a few weeks after stopping the medication, so it will not affect future pregnancies. For all fertile female patients, there will be mandatory, direct, and repeated discussions about pregnancy, contraception, and the mandatory need for periodic pregnancy testing. Please do not be embarrassed: I have this discussion with all female patients contemplating Accutane therapy! Because of the potential for severe birth defects, any sexually active female must decide in advance what she would do in the event that she did become pregnant while on Accutane. As I told you, I believe that if exposure to Accutane occurs during a pregnancy, the pregnancy should be terminated. I have never had a patient become pregnant while taking Accutane, and do not ever what to have this happen!

Mental Status Changes and Depression

Although Accutane is a truly miraculous drug, it does have well known and potentially serious side effects. But virtually all medications, it should be noted, including aspirin, penicillin, Tylenol and even vitamin pills have potentially serious side effects. Accutane has recently come under increased scrutiny by the public, the media, and the FDA because of charges that it may have induced serious depression in some patients. Tragically, a number of patients, while on courses of Accutane, committed suicide. Of course, many individuals over the last two decades who were not on Accutane also became depressed and some even committed suicide. What is scientifically unclear is whether there may be a significantly increased risk of depression and mental status changes in people on Accutane compared to similar people not on Accutane.

In almost twenty years of prescribing Accutane, I can recall only one patient who developed some depression while on Accutane. In my experience, and the experience of my colleagues, the development of serious depression while on Accutane is certainly a very rare event. I have, on the other hand, treated many patients who were depressed before starting Accutane. I do not recall any worsening of depression in any of these patients while on Accutane. I do recall that many of these patients had a dramatic clearing of their depression as their acne cleared. I believe most dermatologists would agree that Accutane is far more likely to improve depression than to induce depression in our patient population. Nevertheless, it is vitally important that patients and their family inform their physician of any changes in mood, activities, appetite, concentration, sleep habits or suicidal thoughts as these could be signs of depression.

In a recent study published in the Archives of Dermatology in October 2000, 7535 acne patients treated with Accutane were compared to 14376 acne patients treated with oral antibiotics. There were no differences in the incidence of depression, psychosis, and suicide among the two groups.

Nevertheless, despite this large study, it is still possible that Accutane could be a factor in the development of depression in a small subset of patients. There are certainly documented cases of patients who have developed depression while on Accutane. Some of these patients noted improvement in their depression when the Accutane was stopped, and some later noted worsening of their depression when the Accutane was reintroduced. This certainly suggests a possible cause and effect relationship in this small subset of Accutane treated patients. There are also reports of depression developing three or more months after stopping Accutane. We know, however, that Accutane is completely out of the body approximately two weeks after stopping the drug. These reports suggest that individuals who happen to develop depression many months after taking Accutane should not look to Accutane as the cause of their condition.

Whether or not Accutane can cause depression is still scientifically uncertain; what is certain is that depression does occur frequently in young people and it can lead to some very serious and sometimes fatal consequences. Therefore, it is vitally important that all patients using Accutane be carefully observed by friends, physicians and family for signs or symptoms of altered mental status including depression. If such changes are noted, appropriate therapy should be initiated at the earliest opportunity.

Lipid (Blood Fat) Abnormalities

Accutane and other vitamin A analogues (synthetic retinoids) can occasionally induce elevations of blood levels of triglycerides and cholesterol. This is rarely a problem in young people, but it is not uncommon in older patients. For this reason, the lipid levels need to be monitored to ensure that there are not any significant elevations. If the lipid levels become markedly elevated, there is a remote chance that serious inflammation of the pancreas (acute pancreatitis) could occur. In my own practice, I have never seen a case of pancreatitis, although I have had quite a few patients experience moderate elevations of their blood lipid levels. Too much alcohol can inflame the liver and raise lipid levels, and so it is wise to decrease or eliminate alcohol use while on Accutane.

Pseudotumor Cerebri

Increased swelling of the brain, which is called pseudotumor cerebri, has been rarely reported with Accutane, along with Vitamin A and other drugs, including tetracycline. If this occurs, patients first experience headache symptoms, and if the headaches persist and become severe, patients could also develop blurred vision, nausea and vomiting. Therefore, patients are cautioned to contact their physician if a severe and persistent headache develops. I have never had any patients develop pseudotumor cerebri in my practice.

Eye and Hearing Problems

Altered night vision has been reported with Accutane. If visual problems do develop, the Accutane should be stopped. Accutane can also cause slight drying of the eyes by decreasing tear formation and this may make it more di difficult to wear contact lenses. Usually this is not a problem with wearers of soft contact lenses. I personally have never had a patient develop any hearing problems, although a few cases of "deafness" have been reported. It must be extremely rare!

Dry Lips and other Skin Problems

Dry skin and chapped lips will occur in virtually every patient taking Accutane. If the lips become too dry, the Accutane can be stopped for a week to allow the lips to recover. The inside of the nose may also get dry and this may lead to minor nosebleeds. Occasionally there can be some increased hair shedding while on Accutane. All these changes generally reverse when Accutane is decreased or discontinued.

Occasionally, Accutane can make cystic acne lesions more inflamed during the first few weeks of therapy. Accutane can also make the skin more sensitive to trauma. Because of this increased fragility, patients should not undergo electrolysis removal of hair, waxing of hair, chemical peeling, dermabrasion, microdermabrasion or laser facial treatments while on Accutane and for a year after coming off of the Accutane.

Musculoskeletal Problems

Accutane may produce muscle inflammation, muscle, and joint pains. This may be particularly common if the patient is on high doses of Accutane and engaged in vigorous sports, such as long distance running. Abnormalities of the bone have not been a significant problem with the use of Accutane in acne.

Questions?

If you have any questions at all about Accutane therapy and side effects, please ask us! Remember that dermatologists have the knowledge and years of experience in using this effective medication, and they would not prescribe it if the risks outweighed the benefits.

Top Of Page