Using Isotretinoin as a Female

When I decided it was finally time to do something about my untreatable acne, I made a dermatologist appointment with the determination that I would do whatever it took to get clear skin. The dermatologists took one look at my skin and said “Accutane®.” An immediate flood of emotions rushed over me. I felt intimidated, nervous, and excited at the thought of having clear skin. “Is my acne really that bad? Isn’t Accutane® only for people with very severe acne? I’ve heard a lot of bad side effects about Accutane® and that it makes you suicidal. Will that happen to me? Am I going to lose my hair?” Despite being prescribed Accutane® at this appointment, I left the office empty-handed. The nurse in the office set me up for a future appointment, four weeks away. This was confusing as most of the time, when I received a prescription, I got a note and went right over to the pharmacy. This time was different. The nurse looked at me and said, “Oh Sweetie, this drug isn’t user friendly for females. We’re going to have to do a lot of tests, sign some contracts, and do some sexual health counseling before you can start.”

And so it began... my journey as a female user of Accutane®. I was scared, felt alone, and couldn’t find the information that I needed. My previous determination was now heeded by hesitancy, “Is Accutane® really worth overcoming these obstacles?”

*Accutane® is the brand name for the generic drug, Isotretinoin. For the purpose of medical clarity, the drug will be referred to by its generic name for the rest of this article. 

 

The Basics

Isotretinoin is the medical name for the previous drug, Accutane®. Accutane®, the brand, is no longer on the market, having been replaced by generics, but the drug is still often referred to by this name. Isotretinoin is a form of vitamin A that reduces the quantity of oil released from your oil glands1. This drug is typically prescribed to patients with moderate to severe nodular acne that has not responded to other treatments such as topical creams, hormonal birth control or antibiotic pills. Isotretinoin is typically prescribed in 5-month doses, with more severe cases requiring additional 5-month rounds of treatments.

 

Isotretinoin has made headway in the news for scary anecdotal stories about potentially life-ending side effects. Politicizing the drug and surrounding misinformation has led the lay public to believe that Isotretinoin will always cause baldness, extreme gastrointestinal side effects, depression, and suicidality. It is important to keep in mind that all medications must list all potential side-effects, including this drug. Some standard therapies for other illnesses have similarly scary potential side effects, but it is rather uncommon for most people to experience those. It is most common for users of the drug to experience chapped lips, dry, itchy skin, and irritation of the eyes and eyelids.

According to the American Osteopathic College of Dermatology, the common side-effects include: chapped lips (90%), dry skin and itching (80%), dryness of the nose, including mild nosebleeds (80%), irritation of the eyelids and eyes (40%), joint and muscle pains (15%), temporary hair thinning (10%), rash (7%), intestinal symptoms (5%), urinary symptoms (5%), headache (5%), increased sensitivity to sun (5%), decreased night vision (<1%) and depression or thoughts of suicide (<1%)1.

 

As can be seen by these statistics, most users will experience unpleasant side effects related to the drying of their skin, lips, eyes, and nose. The more severe side-effects, which are often highlighted in news stories and reports about the drugs, are rare. For example, hair thinning only affects 10% of patients, and usually subsides after the course of drug therapy is complete and the user stops taking Isotretinoin1.

Depression and suicidality are reported to occur in less than one percent of users1.  While any person considering using this drug should talk to their doctor about the potential risks of using any medication, it is also important to keep in mind the psychosocial effects that having bad acne has. Acne can cause depression regardless of whether this drug is being used.

Deciding to Take Isotretinoin

The initial dermatologist appointment may or may not be an emotional experience. You may feel happy to potentially have clear skin, eager to began the drug therapy, apprehensive from listening to your friend’s anecdotes, scared from hearing media stories, or even anxious about potential side-effects. This is very normal. Taking Isotretinoin is not something that should be done lightly, so it is completely normal to have a rush of emotions come over you.

 

If you have struggled for years with acne and have tried every acne product to clear it, you might feel like you are alone in this fight for clear skin. It is important to remind yourself that over 2 million people have used Isotretinoin and have also felt alone. While this is a big step that requires the close supervision of a licensed practitioner, you can remind yourself that you are sitting in that dermatologist’s chair embarking on a mission to clear skin and you are not alone.

Isotretinoin is only available from certified pharmacies under a program called iPledge2. If you decide to begin taking Isotretinoin, you will quickly become familiar with the iPledge program. Every user of Isotretinoin, male or female, must register in this program before beginning treatment2. While this may sound intimidating because you likely have never had to sign a pledge to receive a medication before, this is done so that all users clearly understand the risks and benefits of taking the medication.

Taking Isotretinoin as a Female

*The following information on Isotretinoin is for female users of the drug. The experience of this drug is different depending on the biological sex of the user. The following information is intended for biologically female users who are of child-bearing age and who are able to become pregnant.

The reason that Isotretinoin is not “user-friendly” for females is because of the effects it has on pregnancies. Just a single dose of Isotretinoin can cause severe birth defects or the death of the baby. This medication should never be used if you are pregnant or may become pregnant2. When navigating through the process of getting this drug, just keep in mind that the difficulties you might face are for your protection and the protection of any potential pregnancies. Through all the birth control appointments, signing contracts and pledges, and monthly pregnancy tests, remember that the drug companies, pharmacies, and doctors mandate this course of action because of how potentially dangerous the drug may be to a fetus. It is absolutely imperative to refrain from getting pregnant while on this drug. Call your doctor and stop using Isotretinoin at once if you think you might be pregnant.

 

Timeline of Getting your Isotretinoin Prescription for Females with Childbearing Potential

Before Treatment

After making the decision with your doctor to begin taking Isotretinoin, you will need to complete a series of tasks before the medication can be dispensed to you by a pharmacy. First, you will need to sign a Patient Information/Informed Consent form for treatment2. This form includes all information on potential side effects of the drug. All patients, not just females, are required to sign this document. Next, you will need to sign a second Patient Information/Informed Consent About Birth Defects2. This form is needed because female users of Isotretinoin need to completely understand how important it is to not become pregnant while using this drug.

 

Next, you will need to complete the first of two pregnancy tests required to begin treatment. This typically occurs about 30 days before the first doses of the medicine are dispensed by a pharmacy. Upon receiving a negative blood or urine pregnancy test, you will receive a patient ID card, which functions as your User ID for iPledge, the system that works with clinicians, pharmacies, and patients to disperse Isotretinoin2. You will need this patient ID card to access the online iPledge system, where you will be required to complete several documents.

After receiving a negative blood/urine pregnancy test, you will need to choose and began using two forms of contraception. Two forms of contraception are required because of the extreme danger to a fetus from even a single dose of Isotretinoin. You must sign a pledge that you will use your two forms of birth control consistently. The iPledge program refers to the respective required contraceptives as the primary form of contraception and the secondary form of contraception2. The following are acceptable forms of primary contraception: Hormonal Implant, vasectomy of partner, hormonal IUD, tubal sterilization, non-hormonal IUD (copper T), hormonal injections, hormonal patch, hormonal vaginal ring, or hormonal combination oral contraceptives2. Note that progesterone-only “mini-pills” and the IUD Progesterone T are not acceptable forms of primary contraception. The following are acceptable forms of secondary contraception: male latex condoms with or without spermicides, spermicides alone, cervical cap with spermicide, diaphragm with spermicides, or the vaginal sponge2. Note that female condoms are not an acceptable form of secondary contraception through the iPledge program. Additionally, natural family planning such as the rhythm method, fertility awareness, or the withdrawal method are unacceptable forms of birth control for use of Isotretinoin. Perfect-use and typical-use failure rates are too high for the unapproved contraceptive methods2.

 

After discussing birth control options with your doctor, you will need to use these two forms of birth control regularly for at least one month. It is impossible to receive your prescription without this one-month waiting period. After that month is over, you will need to complete your second pregnancy test within the first 5 days of your menstrual period. After receiving a negative second pregnancy test, you will be required to sign in to the iPledge program online. Your clinician will need to access this online system first and report the negative pregnancy test result. You will then be asked to complete a questionnaire which asks you about potential risk factors and appropriate contraception use while on Isotretinoin. Once all these steps are completed, you will receive your prescription for a 30-day supply of Isotretinoin. The prescription needs to be picked up within a five-day window of answering your questions online2. Congratulations, you are now ready to begin treatment for acne using Isotretinoin. You’ve come so far in the process of receiving this drug, now is the time to begin clearing your skin!

During Treatment

First and foremost, do not donate blood at any time during treatment or for one month after treatment stops2. Isotretinoin users, male and female alike, must refrain from donating blood. If the blood a user of Isotretinoin is given to a pregnant woman, there are extreme dangers to her fetus.

Isotretinoin is typically prescribed in five-month doses. Each month during therapy, you will be required to complete certain steps to receive your next month’s prescription.  It is imperative that you continue using your two forms of contraceptive consistently. If you think you may be pregnant, stop using Isotretinoin immediately and call your doctor. Additionally, you will need to see your physician every month for a pregnancy test in an approved lab. Do not hesitate to contact your physician at any time during treatment, especially if you are experiencing side effects of concern. If you have any non-urgent concerns after beginning your treatment, do not hesitate to ask your clinician during these monthly check-ups. Your clinician must be certified with the iPledge program, and thus, has probably had countless patients who have used this drug. Chances are if you have any concerns or question, patients before you have had the same ones. Clinicians can advise you on the use of moisturizers for dry skin, chap sticks for dry lips, or body washes that will not damage the skin.

 

After completing the monthly pregnancy test in an approved lab, you will again need to access the online iPledge system to answer questions. Once this is complete, you will be able to get a 30-day supply of Isotretinoin2. This process must be completed every month in order to continue treatment. While enduring through the Isotretinoin process, just keep in mind that the difficulties you might face are for your protection and the protection of any potential pregnancies. Pregnancies need to be reported to the iPledge program by calling 1-866-495-0654. Additionally, any patient who is pregnant needs to contact the doctor who prescribed them Isotretinoin2.

After Treatment

For one month following treatment, do not donate blood2. After the last dose of the five- or six-month course of Isotretinoin treatment is completed, you will need to get a pregnancy test in an approved lab. You must also continue to use the two forms of birth control for one month after the last dose of Isotretinoin. After that month, you must get a final pregnancy test2. You may continue the contraceptive use after the acne treatment ends if you wish to continue to prevent pregnancies. Additionally, be aware that condoms are the only form of contraception that provides any protection against sexually transmitted infections. While you are no longer required to use condoms, it is still a good practice to have safe sexual encounters, especially if you are engaging in high-risk sexual activities, such as anal sex or having multiple partners. If you have any questions about your contraceptive use following treatment of Isotretinoin, contact your doctor.

References

1. “Accutane." AOCD. American Osteopathic College of Dermatology, n.d. Web. 1 Mar. 2016.

2. Isotretinoin Educational Kit for Female Patients Who Can Get Pregnant. Phoenix: IPledge Program, 2012. Print.

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