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FDA approves first nonprescription daily oral contraceptive

fda.gov

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Re: FDA approves first nonprescription daily oral contraceptive

#161

Post by idopmstuff »

yjftsjthsd-h wrote: post #127
pevey wrote: post #97

Earlier quoted context omitted.

How does the pill being prescribed by a doctor help this? Do you think doctors are actually explaining this to patients? They are not. They don't have time. The PE firms who own them won't let them take the time.

I would expect someone to explain it; if not technically a doctor then a nurse or such, which is consistent with my experience of medical appointments.

Sure, it should be explained, but the point is that there's no value in only enabling a scarce resource (doctors) to explain something that doesn't require any medical training (take this once a day at the same time).

The pharmacist can explain it. You can put it in huge text on the packaging. You can text or email people.

You could literally make someone DocuSign a single page PDF that just says "THIS ONLY WORKS CORRECTLY IF YOU TAKE IT AT THE SAME TIME EVERY DAY" in order to get their prescription.

All of these options get the exact same message across without being inconvenient and causing people to miss taking their birth control because they couldn't get a doctor's appointment, etc. There are costs to making people go into a medical office that you can't ignore here.

Re: FDA approves first nonprescription daily oral contraceptive

#162

Post by lotsofpulp »

macintux wrote: post #109
quercusa wrote: post #55

Earlier quoted context omitted.

The plant in India’s southern Tamil Nadu state produced eyedrops that have been linked to 68 bacterial infections in the U.S., including three deaths and eight cases of vision loss. Four people have had their eyeballs surgically removed due to infection. The drops were recalled in February by two U.S. distributors, EzriCare and Delsam Phama. https://www.pbs.org/newshour/health/fda-finds-sterility-issu...

There have been comments on previous discussions here that indicate the safety culture in Indian drug manufacturing is shockingly bad.

If you have ever lived in, been to, or even seen videos of life in India, then this would not be shocking.

The people living there, and especially working the low paid jobs in these factories and whatnot, have bigger risks to worry about than safety in drug manufacturing.

Re: FDA approves first nonprescription daily oral contraceptive

#163

Post by jlarocco »

candiddevmike wrote: post #12
lalaithion wrote: post #8

This is amazing, it will help a lot of people have access to a drug that can vastly improve quality of life without being gatekept by their doctor. Just one note about the phrasing of all the headlines: they’re phrased as if the FDA did a good thing, but it’s better to imagine this as the FDA _stopping_ doing a bad thing. The only reason that we haven’t had over the counter oral contraceptive for the last fifty years…

There's a bit more nuance here. There is certainly a political angle, but there is a non zero risk with taking something like this that should be discussed with a doctor first, IMO. Bypassing a doctor does open up access, but there may be risks, especially if folks don't take the medicine correctly.

Walking across the street is a risk. Should I be required to discuss it with my doctor first?

If you're concerned, you can talk to your doctor first. No need for everybody to live their lives by your whims.

Re: FDA approves first nonprescription daily oral contraceptive

#164

Post by thepasswordis »

pevey wrote: post #113
jncfhnb wrote: post #82

Hmm idk. My anecdata of one wife had a really bad time with oral contraceptives. I feel like behavioral side effects are pretty insidious. She got pretty bad anger problems that would only appear to manifest with those she was very close to (and 95% of the time was me). It was difficult to convince her that her emotions were being selectively biased. Which is a bit of a causality minefield to get into. I worry that m…

Oral contraceptives do have side effects, including effects on mental health. Sometimes the effects seem to be positive. Often, they are quite negative. These effects are not taken seriously/acknowledged by the vast majority of medical professionals, so I don't see how it is relevant to whether the pills have to be prescribed. It is a separate issue. People should be free to make their own choice without going throug…

There's an association with "needs a prescription" that people have about the seriousness of the medication that they are taking. "Over the counter" sortof implies that you can't mess it up, or that it isn't really dangerous

Re: FDA approves first nonprescription daily oral contraceptive

#165

Post by sidewndr46 »

giantg2 wrote: post #18
willcipriano wrote: post #6

> The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescript…

Yep, because it's relying on the cultural knowledge that has been built up over the years through things like health classes and society talking more openly to share knowledge. And people really don't understand all the potential risks for most medications they're on, whether Rx or OTC.

IDK what culture you're referring to but where I grew up in the US it is not legal for the education system to inform students about what contraceptives are and how to use them. So I find this argument of yours completely bogus.

Re: FDA approves first nonprescription daily oral contraceptive

#166

Post by giantg2 »

giraffe_lady wrote: post #120
rcstank wrote: post #104

Earlier quoted context omitted.

Is this not a slippery slope fallacy?

It is not. Significant minorities of the anti-abortion movement are also anti-contraceptive. There are articles and even draft legislation published by these groups from 15+ years ago detailing the ultimate goal being bans on contraceptives. You could believe they can't achieve those goals, I guess, but believing they want to is not a fallacy in this context come on.

I can see that. It's very similar to significant minorities in the gun control movement. On either issue, premature movement to counteract them could bring more harm than good.

Edit: why disagree?

Re: FDA approves first nonprescription daily oral contraceptive

#167

Post by kridsdale3 »

NateEag wrote: post #76

This reminded me to look up Vasalgel again (a single-application, non-hormonal, long-lasting, reversible male contraceptive that is unfortunately not yet commercially available), and I see that it seems to have taken a meaningful step forward: https://www.parsemus.org/humanhealth/male-contraceptive-rese... Apparently a company's moving forward with an attempt to productize it: https://www.planaformen.com/ With an opt…

There are tens of thousands of men taking injectables in the US and worldwide today who completely bypass the medical gatekeeping establishment. These injectables have been shown to reduce fertility to nil and last for up to 6 months.

The specific one in question here (very dangerous in small doses, do not seek) is https://en.wikipedia.org/wiki/Trestolone

These men also have an extremely high risk of side effects (as they are taking some of the strongest androgens) including:

- Losing fat

- Getting extremely strong and muscular

- Deepening of the voice

- Awful sleep disruption which leads to irritability, with profoundly violent and sexual dreams

- Much lower patience

- A sense of high-energy

- Acne all over the place, that becomes cystic and doesn't respond to typical treatment

- Big increase in body hair

- Big loss of head hair

- Enormously increased chances of death from heart disease or liver or kidney failure

Most guys are taking this for the muscle and energy effects, and consider sterilization a side effect. It's when the same molecule is being looked at from the perspective of temporary sterilization as the desired effect that all the bodybuilder stuff becomes the side effect.

Re: FDA approves first nonprescription daily oral contraceptive

#169

Post by gwern »

lalaithion wrote: post #8

This is amazing, it will help a lot of people have access to a drug that can vastly improve quality of life without being gatekept by their doctor. Just one note about the phrasing of all the headlines: they’re phrased as if the FDA did a good thing, but it’s better to imagine this as the FDA _stopping_ doing a bad thing. The only reason that we haven’t had over the counter oral contraceptive for the last fifty years…

Same story with home pregnancy tests: https://www.nytimes.com/2016/07/31/opinion/sunday/could-wome...

Re: FDA approves first nonprescription daily oral contraceptive

#170

Post by nopeYouAreWrong »

jjkeddo199 wrote: post #148

[flagged]

There are so many issues with your post that I feel like I'm on reddit?

It's not a radical idea, or really even unpopular, to incentivize child birth through tax policy.

Insane initial implication that having children is a duty we all innately have to society aside: you can't tax an age bracket differently let alone at point of sale.

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