Isotretinoin:
Also known as Accutane, this is an old but fabulous option for acne, even severe cystic acne that can scar. This medication is part of the class called, oral retinoids, which is a “sister” variant of Vitamin A. Retinoids work in the skin by decreasing acne inflammation and sebum (oil) production.
When Isotretinoin was first used (back in 1982) this was being used in teenagers who had flaring acne. Doctors found that this medication worked very well and patients didn’t have to stay on the therapy forever.
But at that time, there were a few reports of teenagers who had committed suicide and they were also taking isotretinoin. Because isotretinoin was new and with these concerns of depression and suicidal thoughts, the FDA slapped the medication with a “black box warning”. Many dermatologists were surprised and decided to dive into this issue further (because of how well it works for acne!).
What do we know about it now?
Since that time, numerous large-scale trials have been done with patients, including teenagers, who were given isotretinoin. In those studies, depression and suicidal ideas were not seen. In fact, the opposite was found! Isotretinoin was found to improve patients’ mood, likely because their acne was clearing and their confidence improved.
Isotretinoin continues to be safely prescribed by thousands of board–certified dermatologists on thousands of patients across the United States every single day.
So what is IPledge?
Although, this medication has been shown to be safe in patients taking it, it is NOT safe for the fetus if a woman becomes pregnant while taking this medication or takes it during pregnancy.
This is not something unique to isotretinoin – there are many other medications that also have a harmful effect to a fetus if a woman is taking it during a pregnancy. But isotretinoin is almost completely used to treat acne. So all of its users are teenagers, who are a patient population viewed by the US government as a high-risk group for becoming pregnant unintentionally.
So it’s for this reason that strict regulations are in place by the US government via their IPledge Program. IPledge is strictly in place to prevent a pregnancy while on isotretinoin – that is its sole purpose and goal.
Here are the IPledge requirements for patients taking isotretinoin:
1) All female patients of child-bearing potential are required to be on two forms of birth control and take a monthly pregnancy test to prove to IPledge they are not pregnant before any refill.
2) Male patients are also required by the FDA to register into the IPLEDGE system.
3) All patients can only be given a max of 30 days of medication at a time and they have to be seen by a physician before getting refills.
What are the expectations?
Most patients who go through a 6-8-month course of isotretinoin never need another acne treatment again. The most common side effects include dry lips, dry nose and dry skin. Occasionally, this medication can elevate our triglycerides in our blood and your doctor will follow this if needed. Depending on your response, your doctor will let you know when you should stop.
If you’re interested in hearing more, click the “Request Appointment” icon in the bottom right corner to schedule an appointment today!
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Isotretinoin?
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