Before you take isotretinoin medication like Accutane, Claravis, or Amnesteem, you will learn about the iPledge program. iPledge is a computer-based system for patients and healthcare providers whose primary goal is to ensure you do not get pregnant before starting therapy or while using isotretinoin.
Why Pregnancy Must Be Avoided While Taking Isotretinoin
Isotretinoin can cause severe, life-threatening birth defects in babies whose mothers take isotretinoin while pregnant. Even a single dose can be enough to harm an unborn child. According to the iPledge website, birth defects caused by isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is also an increased risk of miscarriage. Premature births also have been reported.
Isotretinoin and iPledge Program Registration Basics
iPledge was developed by the Food and Drug Administration (FDA) in an effort to protect against preventable birth defects and other pregnancy-related side effects of isotretinoin. The intent of the iPledge program is to provide a system of checks and balances to reduce the chance of fetal exposure to this drug.
Everyone who uses isotretinoin, regardless of age or gender, is required to enroll in the iPledge program. Healthcare providers who prescribe isotretinoinand pharmacies that dispense it also must be registered in iPledge.
Before your practitioner can write you a prescription for isotretinoin, they will explain how this medication is used and tell you the risks and possible side effects. Your healthcare provider will also explain in detail the iPledge program. You must understand and agree to all terms of the program before you can receive a prescription.
Meeting the Requirements for Qualification
Learning about isotretinoin and its side effects is just the beginning of the iPledge program. You must also meet certain requirements before you will be qualified to receive your medication. Requirements of the iPledge program includeusing two methods of contraception or practicing 100 percent abstinence during treatment, having negative pregnancy tests each month (for people of childbearing potential), seeing a healthcare provider monthly, and submitting to regular blood tests as needed.
Once you have completed the necessary steps to enroll in the program, you will receive an iPledge card with an identification number. You will need this number each time you pick up your medication.
You will also have some criteria you must meet each month to get your refill. Each month, you will have an appointment with your healthcare provider who will enter your information into the iPledge database and verify your negative pregnancy test using a CLIA-certified laboratory for women of childbearing potential. Then, your practitioner will write your prescription. You will only get enough medication to last the one month between the required visits.
The pharmacist filling your prescription must also verify through the iPledge system website (or over the phone) that all criteria have been met. Your pharmacist must obtain authorization before giving you the medication. The iPledge program also requires your prescription to be picked up within a certain time frame. If you're a person of childbearing potential and you miss this window (seven days starting from the date of a pregnancy test), you will have to go through the monthly qualification process again.
Criticism of the Program
There has been some criticism of the iPledge program, with some patients viewing the monthly pregnancy test requirement as unnecessarily intrusive and a potential disruption of their privacy. Healthcare providers have raised concerns that the program is too cumbersome and difficult for patients to adhere to, particularly the monthly pregnancy tests. Very little information is available on how patient data is stored in the iPledge program, which has also raised patient privacy concerns.
The Bottom Line
Despite concerns raised about the iPledge program, the current rules still require anyone taking isotretinoin to register and submit to this monitoring. Ultimately, the program has been a proven system for preventing devastating birth defects and harmful side effects of Accutane and other isotretinoin drugs.
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The requirements include the patient taking pregnancy tests and using 2 forms of birth control consistently for at least 1 month prior to initiation of isotretinoin treatment, during isotretinoin treatment, and for 1 month after discontinuing isotretinoin treatment.
You must use two acceptable forms of birth control for 1 month before you begin to take isotretinoin, during your treatment and for 1 month after your treatment. Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control.
Because of isotretinoin's teratogenicity and to minimize fetal exposure, isotretinoin is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE.
Isotretinoin is a potentially dangerous prescription medicine that should only be taken under the close supervision of your healthcare professional and pharmacist. If you are pregnant or may get pregnant, isotretinoin can cause birth defects, miscarriage, premature births, and death in babies.
Before starting isotretinoin, you must have 2 negative pregnancy tests 30 days apart. Pregnancy tests must be done at your doctor's office or at a lab. You cannot use store-bought pregnancy tests. In order to pick up your prescription, you also need to have a negative pregnancy test every month.
Accutane® and its generic products should be taken with food. Absorica® may be taken with or without food. Do not crush, break, chew, or suck the capsule. It is very important that you take isotretinoin only as directed by your doctor.
You should not donate blood while taking isotretinoin or for one month after stopping isotretinoin. Isotretinoin can increase the risk of scarring after some procedures that are used to smooth the skin, such as waxing, dermabrasion, and laser resurfacing. Avoid these procedures while taking isotretinoin.
Monitoring and Laboratory Tests: The following tests are required before starting ACCUTANE, at first month, then as clinically indicated: serum blood lipid, complete blood count (CBC) and differential, liver function, and blood glucose levels.
are trying for a baby, pregnant, think you may be pregnant or you're breastfeeding. have liver or kidney disease. have high levels of cholesterol or other fats in your blood. have high levels of vitamin A in your body.
Despite its efficacy in treating acne, isotretinoin has reportedly been associated with suicide and a range of psychiatric disorders, including depression and anxiety,2 which has resulted in a black box warning for suicide, depression, aggression, and psychosis issued by the US Food and Drug Administration in 2005.
The drug causes serious side-effects, most notably birth defects. Accutane is also one of the most effective prescription drugs available. This combination—unique efficacy coupled with unique risk—has posed a serious challenge for the Food and Drug Administration (FDA).
If it's biologically possible for you to become pregnant, iPLEDGE requires you to agree to using two forms of birth control. This is usually required regardless of your sexual orientation, gender identity, or level of sexual activity.
Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, prescribe or dispense isotretinoin.
Isotretinoin sponsors will ensure that healthcare providers who prescribe isotretinoin are specially certified in the iPLEDGE Program. To become certified, each prescriber must activate registration, by completing the Prescriber Enrollment Form, via the iPLEDGE website or the automated phone system.
Introduction: My name is Dr. Pierre Goyette, I am a enchanting, powerful, jolly, rich, graceful, colorful, zany person who loves writing and wants to share my knowledge and understanding with you.
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