Wednesday, June 20, 2012

An Example of the Crazy

Since Carly has been off the baby blockers, she's been experiencing the full range of female hormones and their fluctuations. She started taking birth control when she was reasonably young, so I'm pretty sure this is the first time her body has actually been allowed to do what it does. And what it does is break out.

Her skin develops ranges and archipelagoes of pimples without warning. No soaps or creams really work. These are hormonal acne and there's really no cure, just maintenance. So she went to see her dermatologist. In addition to being a bit of a spaz, he prescribed to her a hormonal-based cream for her zits, one that will knock her back to that semi-bound state that she was when her skin was clear. The nurse of course warned her that if she was going to get pregnant, she'd have to stop taking the stuff. The doctor said, like a spaz would say, "Yeah, um, yeah, you can't take it if you're pregnant, but they haven't really done any studies, and um, like, one in four pregnancies aborts anyway, so yeah."

Reading the materials that come with the goo, you get this disclaimer:
8    USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C. There are no well-controlled trials in pregnant women treated with [PRODUCT] Gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore [PRODUCT] Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
No teratogenic effects were observed in rats treated with oral dozes of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dose (MRHD) of 2 grams of [PRODUCT] Gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of greater than or equal to 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits.
Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-29 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.
Okay, so this says that the drug is a Pregnancy Category C substance, and rightly defines it as something that has risks in animal tests, but may be used if there's a good reason during pregnancy. Those reasons are not well-defined, but I'm betting, "I want to look good in my pregnancy boudoir photos," is good enough.

It then says that no teratogenic effects were observed in rodents given oral doses in excess of 25x the recommended maximum dose for humans. Remember, what Carly is using is smeared on the skin--the rats and bunnies were taking it orally. Teratogenic basically just means "birth defects." It ranges from weird birth marks to extra heads, and so on. The range of things that happened to the bunnies and rats was relatively minor... when exposed to 123 to 246 times the maximum human dose, the rodents had some cleft palates (Hares with hare lips? OH THE IRONY!), buggy eyes or small, lazy, blind eyeballs, and encephaloceles.

That last one is a bit of a scary one--encephaloceles are protrusions of the brain and spinal cord generally caused when the neural tube fails to close completely during the fetal stage of pregnancy. So your brain matter bulges out of your skull. It's really grody, but generally treatable... the matter that's hanging out is usually not functional and can be cut off or packed back in the skull. Some people live their whole lives with that condition, though it is the source of a lot of problems. Very Mutter Museum stuff.

That's not to minimize the deformity--lots of encephaloceles are fatal, non-operable, or end up causing permanent damage to the brain when removed. So it sucks. And lazy eyes and cleft palates are no laughing matter, either. But the point is, the baby websites freak the fuck out about things like this. They tell you to not even think about any kind of acne meds or whatever, even if they don't include any of the chemicals that work in this one, because WHAT IF your baby has a second head??? The problem is that the readers and the writers don't rely on what the science actually says...

It says, if you slather on 200 times more than we tell you you should EVER put on your skin, your baby has a small chance of having a deformity that is very likely operable or at least not fatal or particularly debilitating if caught early enough. If you're the sort of person who overdoes things, you probably should stay out of the drug store, except to buy condoms. Lots and lots of condoms.

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