John R. Tkach, M.D.
300 North Willson, Suite 203B
Bozeman, MT 59715
(406) 587-5442

Accutane (13-cis-retinoic acid, Isotretinoin)

Patient Information Sheet

Accutane has been available for physicians to prescribe for patients since September 1982. It has proven dramatically effective for many people with severe cystic acne. In the initial trials, many severe cystic acne patients who completed a 20 week course of Accutane cleared up and stayed clear for as much as two years. For this reason, it was touted as a "cure for acne." Subsequent experience has shown that, while Accutane may produce dramatic improvement in cystic acne, it is not a cure. However, it is a welcome addition to the medicines available for treating acne. It is usually the strongest medicine to treat acne. It is the treatment of last resort.

Doctors and patients have built up a lot experience with Accutane. Now, in most cases, four months of Accutane treatment will be enough, rarely, five months, and very rarely six months. 90% of people completing a course of 1 mg/kg/day will not need a second course of Accutane.

Severe comedonal acne is considered to be an unapproved use of Accutane, because Roche labs did not include that use in the initial development of the drug. I have had four patients get wonderful results from Accutane for this acne. It is used for this in England and Germany.

That is the good news. Now for the bad news. It has a lot of potential side effects, and some of them are quite serious. Before committing yourself to a 4 months course of Accutane treatment, I want you to know what you are getting into. In actual practice, treatment seems to go well.

If I suggest Accutane to you, it is because I think it is the best medicine for your problem. Some people with acne that is moderately severe request Accutane because they are tired of years and years of fighting with acne. They would rather use 4 months of Accutane that take antibiotic pills for another 10 years.

The mechanism of action of Accutane is unknown. It reduces the production of oil (sebum) by the sebaceous oil glands in the skin by 80% to 90% after about the first two weeks of therapy. It also reduces the number of bacteria (Propionibacterium acnes) growing on the skin. After stopping the drug, the oil and bacteria come back, but the acne may remain clear.

Even in those cases where the acne returns, it may be so much milder that more economical medications can be resumed such as antibiotic pills. Some patients who do not get enough improvement from a regular course of treatment benefit from going off Accutane for 2 months and then taking a second course of treatment. But that is rare.

Usually, the acne improves by about the 6th to 8th week of treatment. If troublesome cysts occur during the course of treatment, I suggest you make brief emergency visits to me for cyst injections and drainage. Just call my secretary for an appointment. Explain to her what the situation is.

Accutane Side Effects Incidence
1. Severely chapped lips. 90%
2. Dry peeling skin, nosebleed, itch 80%
3. Irritation of the eyes- conjunctivitis 38%
4. Increased blood fats. 25%
5. Muscle & joint pain 6%
6. Rashes, hair loss, headache, sunburn 5%

In my experience, there is about a 95% probability that you will have chapped lips. About 90% of my patients have dryness and a red color on their faces. This red peeling appearance of the face and lips is so characteristic of patients on Accutane that I call it the "Accutane look." Fortunately, it is temporary and goes away after stopping Accutane. These side effects usually reach their worst at about 2 months of treatment. After that they tend to improve.

Effects on the Reproductive System

I have been personally assured by the Roche Company's representative Dr. Steven Billstein in San Francisco that Accutane does not damage the sperm or eggs, decrease fertility, or induce sterility. It does damage a developing fetus.

But, ACCUTANE CAUSES SEVERE BIRTH DEFECTS IF TAKEN DURING PREGNANCY. Therefore women taking Accutane must use two forms of contraception preferably birth control pills. Women must wait 4 to 6 months after stopping Accutane before getting pregnant. A woman starting Accutane during pregnancy will possibly deliver a deformed baby and thus will have to terminate her pregnancy-- have a therapeutic abortion. The risk of severe unacceptable side effects of Accutane taken during pregnancy is 37%. There is a complicated and time consuming series of forms we must go through before women of child bearing potential start Accutane. There are also forms for men, but shorter.

While current evidence suggests Accutane does not damage sperm, I personally prefer that men not try to conceive a child while on treatment. Wait until you have been off Accutane 4 months to be safe. This may not be necessary, but I would feel better if you would follow this advice.

WOMEN MUST NOT GET PREGNANT WHILE TAKING ACCUTANE. WOMEN MUST BE ON BIRTH CONTROL PILLS DURING TREATMENT. I urge you to see your gynecologist or family doctor or a nurse practitioner at the family planning clinic and ask him/her to give you birth control pills for the time you are on treatment and for the four months after you finish. That will be about 9 months altogether.

Women should wait until the second day of the next menstrual period and we have a negative pregnancy test before beginning treatment. Then start Accutane. The written prescription will be tagged with a yellow sticker. You must buy the pills within 7 days. If you do not, we have to go through another visit and lab study (serum HCG) and write a new prescription.

Effects on Blood Fats

For some reason, Accutane stresses the balance of fatty acid metabolism Some patients experience a significant increase in blood fats (triglycerides). Such an increase may, over a long period of time, be associated with increased formation of fat deposits in the arteries. This may cause an increased risk of heart attack. It is unlikely that the low levels of increased blood fats that occur during the 20 weeks of a course of Accutane would cause problems. I will have you get your blood triglycerides checked the third week of treatment. It must be done. If the serum triglyceride level becomes elevated but stays below 350 mg%, the treatment can be continued. If the level rises to 350 to 500 mg%, you will have to avoid alcohol and reduce dietary fats. It the level rises above 500 mg%, we will have to decrease the dose of Accutane (and decrease the effectiveness). If the level goes above 800 mg%, we will have to stop treatment.

Adverse Drug Interactions

You cannot take any Vitamin A while using Accutane, and that includes vitamin pills. Accutane contains Parabens preservatives. If you get rashes from creams containing parabens, do not take Accutane. Please let me know what medicines you take so I can run a Medical Letter Adverse Drug Interactions search to make sure the combination is safe.

Accutane and Depression

Does Accutane cause depression? For a while, there was concern that Accutane induced depression. A study done at Harvard University found that, to the contrary, people treated with Accutane are less depressed. This has been my experience. Improving this difficult skin problem brings people relief and makes them happier. However, we shall monitor depression with a monthly questionnaire.

Other Adverse Effects

The package insert will list the side effect de Jour. My experience since 1982 has been that other problems are rare. I have had two people who felt tired. We did a white blood cell count and found there was a decrease in the number of white blood cells. Let me know if Accutane makes you tired.

Management of Side Effects

Chapped lips will certainly occur. I will be surprised if they do not. Wet the lips with water (not saliva--do not lick your lips) and rub in any dry skin lotion . For dry skin, wet the dry areas and rub in a dry skin lotion. For severe peeling of the palms and soles, Eucerin Plus works better. You can buy it without a prescription.

For sore eyes apply a drop of "Liquid Tears" as needed.

For muscle and joint pain, take 1 enteric-coated aspirin tablet as much as every six hours. But try to take as little as possible. You can buy enteric-coated aspirin without a prescription.

Cost

The generic substance of Accutane is 13-cis-retinoic acid. Cost varies widely. Claravis brand may be cheapest. Accutane brand is most expensive. The price ranges from $8.30 per pill to $25 per pill. One-month cost varies from $498 to $1500. I do not see any reason not to look for lower cost choices for this. The good news is that it does not go on forever, just four months.

In 2010, my cost estimates for a 4-month course of treatment range from about $2,000 to $6,000. Before starting Accutane, check with your insurance company to see if they will pay some of the cost and how much. If you need a letter from me, just let my secretary know.

Lab Studies

Both men and women should have a blood triglyceride test done after the first month. That test requires that you be fasting for 12 hours before the test is done. Fasting means that you do not eat for the 12 hours before the test. For example, If you are going to have the lab draw the sample at 8 AM, you must not eat from 8 PM the night before. You can have water but nothing else. Usually, we only do this test once.

In my opinion, for women, you must get a pregnancy test every month. This is to monitor and make sure you do not get pregnant. I shall give you a stack of lab slips with the dates. You can get the lab done at the lab in my office building or at the hospital lab.

I want the Accutane treatment work for you. I shall hold your hand through the treatment. If you are having trouble, call me. If you are not sure what to do, just stop taking Accutane for a few days until you can in touch with me.

iPledge Program

This is a government directed organization that strictly controls the dispensing of Accutane through a computer network that communicates with all pharmacies. It is awkward and frustrating. It is a pain in the neck, but we must put up with it in order for you to get your prescriptions filled. For a woman to deliver a seriously deformed baby is such a catastrophe that I put up with iPledge. Over the past few years, iPledge has altered the rules and regulations regarding dispensing Accutane, so many times, the rules are rules de jour. Women on Accutane must not get pregnant.

Informed Consent

I have read the above information on Accutane treatment and understand the risks. I want Dr. Tkach to treat me and agree to his guidelines. (For Women) I am not pregnant and agree not to get pregnant while using Accutane (for women only). I will not try to conceive a child while taking Accutane (for men).

There will be paperwork for you to complete when you arrive at my office for this treatment.

The information provided in these patient information sheets is offered for general informational and educational purposes only; it is not offered as and does not constitute medical advice. In no way are any of the materials presented meant to be a substitute for professional medical care or attention by a qualified practitioner, nor should they be construed as such.

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