Every time this comes up now, I ask the same question, and I still haven't gotten an answer to satisfy me. Could someone please point me to the studies showing that it is safe for all ages?

The closest that I've ever come is a comment on Pharyngula pointing me at the quotes from the GAO report noting that there are no age restrictions on prescription or OTC contraceptives, and that the FDA has not required pediatric studies for them.

I'm starting to come to the conclusion that Plan B has not been proven safe for all ages, and that the belief is entirely due to extrapolation from studies of birth control on adults. (This may be an entirely reasonable extrapolation, certainly, and I lack sufficient training to make a case one way or the other, but it doesn't justify a claim of "proven safe".)

It's hard to believe this finally happened...I feel like throwing a party!

Kinda gives me chills thinking about the battles women have to fight in order to get what we need.

Of course, it's going to be sold over the pharmacy counter, which means we'll still have to deal with pharmacist nutbags.

Can't wait to see what kind of fines they're going to impose on procuring EC for a minor.

The way I see it this leaves enforcement of the age requirement up to the pharmicist. However it's only a matter of time until some Xtian wacko tries to use his underage daughter in a sting to try and strip som poor pharmicist of his licence. It shouldn't be any harder to get ahold of than a pack of cigaretts. At least most places it won't.

Oh, and Zed while I can't point to any studies, I can speculate that Plan B is safer than than the alternatives. i.e. abortion and pregnancy. Keep in mind it is "Emergency" contraception. It shouldn't be relied upon solely.

zed,

I 'Scifinder'ed levonorgestrel and under 16 an came up with 379 hits which is more than I'm going to think about looking at, but in N.C.Sambol et al. Contraception (2006), 74(2), 104-109

Zed-
The FDA's own medical safety review of Plan B does not indicate that the drug is any less safe for teens than it is for women ages 18 and up.

Studies also show teenagers are able to comprehend the labeling and correctly take Plan B without a doctor's supervision. (In one study, teens had a better understanding of the label info than women in the 26-50 age bracket.)

racya:

Oh, it's almost certainly safer than abortion or pregnancy. I'm just a little bothered by the "proven safe" wording, when as far as I know, nothing has been proven.

chem_fem:

Alas, nothing more came through on my feedback link than showed up here, but I've sent you a response by e-mail, and would appreciate it if you would try one more time by replying to it. If it comes through that way, I'll format it and post it myself.

Ann:

Thanks for the links. I've scanned through the entire FDA medical safety review now, however, and to be extra certain I also ran searches on "child", "teen", and "18", and didn't find anything relevant. Are you sure you linked the document you intended?

The second document is quite large, so I have not read it from beginning to end, but a quick search led me to believe that you're referring to the results on page 45. Unfortunately, closer examination of those results does not support your claim. They are broken up into three categories: 12-16, 17-25, and 26+, and for the purpose of evaluating safety of not having an age limit at all, the 17-25 group should be bracketed with the 26+ group as "adults" (though certainly, this could well be used as support that the age limit should be 17 instead of 18). Unfortunately, the results for the 12-16 group show that, in fact, 12-16 year olds get pertinent facts wrong significantly more often.

I wish I could see the error rate broken down by year for every year below 18, but that result alone is telling me that the age limit for EC without a prescription should not drop below 16, and that the claim that Plan B has been proven safe for all ages is demonstrably false.

As promised, I'm posting the abstract that chem_fem found and sent to me by e-mail:

Nancy C. Sambol et al. Contraception (2006), 74(2), 4-109

The study concludes after tests on 20 girls that: Levonorgestrel was generally well tolerated by adolescents in this study. Based on the totality of the data, differences in observed total concentration are not likely to be seen in the unbound concentration, although we are unable to confirm this hypothesis.
Even if the suspected lack of difference in unbound concentrations could be not be verified, it most likely would not be clinically significant because empirically large doses of levonorgestrel are commonly prescribed. In conclusion, there is no pharmacokinetic reason to expect that adolescents will experience greater adverse effects or lower therapeutic effects after administration of the usual dose of emergency contraception.

I'm not quite sure what the definition of "adolescent" is in this study, but I'm going to assume it covers the 12-17 range, so any objections would have to stem from decreased ability to follow recommended usage rather than an increased inherent medical risk.

Here's a question for the "pharmacists nutbags":

If prevention equals abortion, such as in the case of EC or birth control, why is it okay to sell condoms? Isn't that just as much a form of preven- I mean, abortion?

At any rate, yay for over-the-counter EC!

evil olive:

The religious right is pushing a view that personhood is magically conferred at the moment of fertilization, presumably even before the first cell division, and certainly before implantation. Thus, barrier methods that prevent any sperm-egg contact are okay, but anything that increases the chance of implantation failure post-fertilization is in theory bad.

Note that this isn't consistently applied, as the rhythm method is still endorsed, despite a greatly increased chance of fertilization followed by implantation failure.

But Zed, every sperm is sacred! Those contracepting couples are ALSO killers! [/dawneden]

Seriously though, if they got their way there'd be no condoms either.

EC has been perscribable by pharmacists in California for over two years now. That's how they got around the FDA holdup on making it available OTC- since the state had no control over FDC decisions, it found a way to skirt around federal law using something it did have legislative power over- state board licensing. They simply granted pharmacists the authority to perscribe EC. So it remained "by perscription only" but only required a single trip to Safeway, Walgreens or any participating local drugstore.

The thing that kind of sucks about it is that the pharmacies offering this "service" are allowed to charge a $10 "consulting fee" (in California, anyway- not sure what the law is elsewhere). So in addition to paying $38 for the single use/2 pill meds, you've got to pay an extra ten spot for what amounts to little more than what a pharmacist's job already entails. And no, they don't accept any kind of insurance (though your prescription coverage may pay for the pills, if you're lucky).

I probably sound like an ingrate, which I'm not, really. But I don't see too many high school students paying $50 for a pill they may not even need, at least not in states where they can get it for free from a clinic. The Planned Parenthood Golden Gate gives "emergency" packets of Plan B for future use during a scheduled appointment, but they (understandably) prefer that you don't use them as a drop-in source.

That's fine for me, since I'm a grown woman who can afford to pay for them every once in a great while when a condom breaks or slips off. But I would imagine high school girls would still be more likely to get them at the clinic if permissible by state law.