"Miracle Drug" Tackles Nodular Acne

Hilary Baldwin, MD

Both a physically and psychologically stressful condition, nodular acne is characterized by red, swollen, and tender lumps that can cause permanent scars if left untreated. Since the lumps can be painful and embarrassing, they can also inhibit patients’ social lives.

However, there is a “miracle drug” for the severe condition, according to dermatologist Hilary Baldwin, MD, clinical associate professor of dermatology, Rutgers Robert Wood Johnson Medical Center. Isotretinoin, which is oral capsules prescribed for patients aged 12 years and older for approximately 6 months, is typically a 1-time therapy that often “cures” patients of acne after treatment.

Since controversies and concerns exist over the medication, Baldwin spoke with MD Magazine® to debunk some of the myths and clarify what real concerns and benefits isotretinoin has.

[Editor’s note: Transcript is lightly modified for readability.]

MD Mag®: What are some of the traditional challenges of treating nodular acne?

Baldwin: “From my point of view, there is only 1 medication for treating nodular acne, so the treatment landscape is extremely small. In general, when someone with nodular acne comes in to see me, I’m solely figuring out what we’re going to do to go on isotretinoin.

The challenge is making sure patients are candidates for it and also—sometimes—convincing the patient or the parent that the bulk of their concerns are “internet hype” and not reality. I try to put things into perspective for them so they’ll feel a little more comfortable about going on the medication.

If we treat these patients any other way, we put them on oral antibiotics or oral contraceptives, which are not without side effects themselves and don’t cure acne. They nearly control it for the period of time they’re on the medication, and when they have to stop, the acne comes back 99% of the time. Then, we have to start all over again.

Isotretinoin’s effectiveness and durability of response led me to always go in the direction of isotretinoin.”

MD Mag®: What is the ‘internet hype’ surrounding this medication?

Baldwin: “This is what I say to put most people’s minds at ease. First, this medication has been out since 1982, and it’s been used to treat about 20 million people worldwide. That’s the last data point that I’ve seen, which is very old, so I’m sure it’s much higher than that.

Since most people are treated with isotretinoin for half a year, we are talking about 40 million people years. When you see a report on the internet that says, ‘I didn’t feel well while I was taking the medication,’ you have to realize this 1 person over 40 million.

Yes, there are potential side effects, but most of them are predictable and can monitored. Virtually, everything except for the risk of pregnancy is temporary. It’s really not as big of an issue as the internet would make you think.

Isotretinoin gets labeled a ‘bad’ drug sometimes because it has so many potential side effects. When you launch a medication, everything that has been reported in more than 2 people has to be in the package insert—anything that has been reported to the FDA.

Because the medication has been out for 36 years, almost anything that can happen to a human body is in that package insert—99% of them are unrelated to the drug, but they happen when people are on the drug. These get reported and placed on the package insert, which is very daunting. It’s several pages long and in very small font. It contains everything that can happen to the human condition; therefore, you get a lot of lawsuits, and it makes people scared when they see all that information.

Thirty-six years is nothing to sneeze at, and the bulk of the stuff in the package insert is not really stuff that is going to happen.”

MD Mag®: What are some of the side effects that are likely to happen?

Baldwin: “One hundred percent of people are going to have extremely dry lips. It’s controllable, but you have to really work at it—put chapstick in every pocket. Lots of people have dry eyes as well.

The second most common side effect drops down to 25% of patients, and that’s a blood test abnormality. At 18% you have muscle ache complains, at 11% you have another blood test abnormality, and everything after that is 1% or less. Doctors don’t even talk about the 1% side effects because they are so rare.

As for the blood test abnormalities, we don’t let those get out of hand. If there is a blood test abnormality, who cares? It’s temporary, we can stop or adjust the dose, and it goes away. Although it occurs in 25% in liver function and 11% in triglycerides, it doesn’t matter because we’re watching and making sure nothing happens.

The “hype” is people get depressed, get pregnant and have abnormal pregnancies, and get inflammatory bowel disease, but some of that doesn’t have any data behind it. Acne makes you depressed, and the time of life people develop nodular acne and go on isotretinoin therapy is also the same time people develop IBS, depression, and other psychological diseases for the first time.

If I can’t assure the patient can’t get pregnant, I can’t put the patient on the medication. Sexually active females need to be on birth control for me to prescribe them this medication.

There is also controversy over taking isotretinoin before an individual has reached his or her full mature height causes premature closure of the growth plate of the bone and could potentially reduce you genetically predetermined stature. This is a theoretical concern; it’s never been demonstrated.

MD Mag: Is there a difference in efficacy between brands of isotretinoin?

Baldwin: Right now we have Myorisan, Claravis, and Amnesteem, which is sometimes available and sometimes is not. Essentially, we have 2 or 3 generics and 1 brand, Absorica, right now. The major difference between Absorica and the other generics is that it has a unique manufacturing process that makes it more soluble without there being fat in the stomach.

Isotretinoin is a fat-soluble drug, and patients need to have fat in their stomachs in order to properly absorb the medication. What has been looked at by the FDA is that patients need a diet of 50 grams of fat per dose with the generics. If the drug is taken twice a day, that’s 100 mg of fat per day. That’s a lot of fat. You can imagine if you’re taking that twice a day how many calories you’re consuming.

I always prescribe Absorica unless the insurance companies say no. I want to know my patients got 100 mg in them because I don’t want their acne to recur. A recurrence is larger exposure to the drug, and it’s a larger exposure to pregnancy.

As far as the generics are concerned, they work, but even though the FDA says generics are equivalent, they are allowed to contain anywhere from 80% to 125% of the comparator. Because of the unique formulation of Absorica, I particularly prefer the brand.

Nodular acne causes psychiatric and physical scarring, and this drug can significantly help with that. If you finish a course of isotretinoin, 80% of people never see acne again. That’s why we push it. I put both of my daughters on it with no problems. I really think this drug is a miracle drug.

Someone once told me, ‘I don’t know a dermatologist whose office is full of depressed, pregnant, fat, patients with acne. Mine if full of young men and women whose lives have been resurrected by this drug.’

That’s the beauty of this drug. It’s not a bandaid on the problem. It’s a cure.