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Oral Isotretinoin Important Considerations

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That’s a pleasure to be here today to talk about one of my favorite drugs for which i have no disclosures i’m characteristically so i thought since it’s the 16th anniversary of the i pledge program and we all wanted to wish you a happy birthday that we would start talking a little bit about pregnancy prevention and start to review what we know about it and what

We’re doing right and what we’re doing wrong clearly we’re recognized with the stakes are very high that the risk management programs have not been particularly helpful for us and i’d like to ask the question is abstinence a valid choice for i pledge birth control and who should be prescribing the birth control so i’ll piggyback a little bit on what julie was

Just talking about the stakes were all well aware of the incidence of embryology depends on the timing and the duration of the exposure but is somewhere between twenty and forty seven percent of fetal exposures we have a lot of defects that can occur as a result of it most of which are quite severe fifty percent of women taking isotretinoin in the united states are

Female and the vast majority of them are females of childbearing potential so this is a particularly important issue to consider everybody always asks you know we’ve gone through all of this with i pledge has it actually worked has it been worth it well we only have data from the first year in 2007 they analyzed the data and they saw that there were about a hundred

And twenty two pregnancies in that year compared to 127 in the previous year on our previous risk management program called smart bear in mind that this also during this year represented a thirty-nine percent drop in the number of prescriptions that were written so that number should have gone down dramatically on the other hand the mandatory pregnancy reporting

That was seen with i pledge might have captured more accurate data and might have shown a great increase in the number of pregnancies as reporting it on smart was only a suggestion and i hazard a guess that many of us who had pregnancies on this drug perhaps we’re not willing to report it so we’re not really sure if i pledges helps compared to smart but at any

Rate we still had 122 pregnancies and law although i have not been privy to the data since then it’s still apparently somewhere in the vicinity of a hundred and twenty pregnancies per year so we can’t rely on the risk management program alone to prevent pregnancy what else do we know about our women taking birth control we know that fifty percent of pregnancies

In the united states are unplanned than more than fifty percent of these unplanned pregnancies say they’re on contraception at the time of conception i don’t think so the first year discontinuation rate of most of our birth control methods is extremely high especially for condoms they start off very gung-ho and then by the end of the year they’ve dropped off by

57% and oral contraceptives by thirty three percent this suggests to me that we ought to be considering long-acting birth control methods like i youjizz and implants and our patients on isotretinoin to take the forgetfulness at least out of the equation so what are our patients actually doing while they’re on isotretinoin well in this small anonymous survey of

Isotretinoin patients who had been on the drug for at least two months twenty-eight percent of those patients had said that they were going to be abstinent throughout their course well guess what only about nineteen percent of them decided to become sexually active or to be sexually active during treatment fortunately most of them did use a birth control method

During that time but only ninety percent used condoms and forty-six percent used oral contraceptive pills twelve admitted to italy using one or fewer forms of birth control during their time on isotretinoin ten failed to use condoms and one said unprotected intercourse the entire time and thirty-nine percent said they reported missing at least one pill per month

Again suggesting that we need to find some way to take the daily use of a product to reduce or an incident youth of a breath control product out of the hands of our patients if it is at all possible so that was the risk of utilizing abstinence an adult woman what about in a teenager well in a study of almost 3,500 middle high school students where half of them were

Folks who had taken an abstinence pledge a pledge to stay abstinent until the time of marriage were compared to age-matched non pledgers what do you think happened about five years later fully eighty-two percent of those who had pledged said what pledge i never signed any kind of pledge become not only did they not do it but they completely forgot or at the preps

They were lying that they had even done it to begin with there was no difference between the two groups in the incidence of premarital sex the pledgers when they did have sex were less likely to use condoms or birth control perhaps because they weren’t prepared or perhaps they weren’t even aware of it if they were going to stay abstinent until marriage perhaps

They had never even had the conversation of what to do should that situation change and increase risk of pregnancies and stds we’re seen in the pledging group compared to the non pledgers so i would suggest to you that you look very carefully at your teenagers who you’re going to call abstinent and make sure you’ve had a very good conversation with them and in my

Opinion a conversation with a mom in the other room so maybe they just don’t understand maybe they just don’t get it right they don’t understand what birth control can and cannot do so this anonymous survey of a hundred women assess the knowledge of contraceptive methods and they did a pretest followed by some reading material and then a post-test and at the time of

The pretest they were asked to rank birth control methods from least to most effective and what they found was it fully over fifty percent of patients overestimated the efficacy of condoms especially but also oral contraceptive pills and injections most of them felt that condoms were infallible for example they did better after they read the material unfortunately

The authors found that the mean amount of time that they spent looking at this crucial and critical piece of information was less than one minute so not only did they not get it but they didn’t seem to care about whether they did get it so i think we all know that if we push too hard with our birth control methods before isotretinoin we may have patients who are

Less than truthful if you say to a young woman its birth control pill is adequate birth control birth control pill iud implant or i’m not going to give you this drug many of them i think in my practice just yes me to death okay give me the prescription or you want it yeah sure i pledge every month yeah i’m on it right they they want the drug and if i push too hard

I’m concerned that i’m going to make them lie to me and i would rather honestly that they be truthful we have some evidence of this in that first data that i showed you for i pledge there were 120 two pregnancies as i mentioned seventy two percent of them pledged that they were using oral contraceptives and condoms again i don’t think so right that the two forms have

Taken appropriately are virtually a hundred percent successful eighteen percent of those who became pregnant said they were abstinent i’m quite sure that that was not a possibility so i’m forced to conclude that our patients forget to use their birth control especially birth control pills and condoms they’re in denial regarding their risk and the effectiveness of

The birth control that they actually are using and unfortunately they also seem to be lying to me i think that this means that the evidence suggests that long acting more infallible birth control methods are more appropriate for our isotretinoin patients so are we doing that are we doing a good job in counseling our patients for contraception on isotretinoin this is

A small study but it was an interview of 16 female college students who had used isotretinoin and they were asked how good was your counseling information by your dermatology practitioner well they said i totally got the idea that this druggist errata genic i got that but the process was very anxiety-provoking it was not like going to gyn and having a conversation

About birth control it was a conversation about birth defect more than it was actual counseling for many of these women this was their first introduction into birth control and it’s a shame that it was it took place under such duress the providers in all cases immediately defaulted to birth control pills they didn’t discuss they didn’t mention the possibility of

Implants and iuds i don’t know if that’s because we’re way more comfortable with birth control pills we just sort of default into that but i suggest that this means that we either need to familiarize ourselves with those other methods and refer appropriately or or refer appropriately get it to a gynecologist who’s going to do a better job i mean how much times you

Have to do birth control counseling under ordinary circumstances so i agree with what julie said under the best of circumstances but i think we don’t have enough time to do this adequately what about muscle fatigue this is something that occurs quite frequently now in my practice i recently switched from brooklyn where nobody ever exercises it all in high school

We’re lucky if we have room for a half a basketball court in school to morristown new jersey where everybody plays ice hockey and field hockey and lacrosse and everybody’s on three teams now i’ve got an issue with muscle fatigue we have numerous musculoskeletal side effects reported on this drug myalgia primarily in patients who are elite athletes and doing a lot

Of exercise reported in about fifty percent of patients in those patients we see an elevated ck frequently fortunately rarely associated with rhabdomyolysis but we have limited data on what this means if your muscle is sore does that mean that you’re actually going to have a reduction in your athletic prowess are you going to be less strong are you going to be

More fatigued or have a lower endurance and should we recommend to our elite athletes especially our teenage kids who have a possibility to college scholarship to avoid utilizing isotretinoin during their active season or perhaps indeed at all so we have one study that looked into this since we started to discuss it a study of 27 acne patients and 26 age-matched

Controls the acne patients were all given isotretinoin starting in a half a meg for kid for a month and then up to 1 milligram per per day for two months they did isis of kinetic measurements of the hamstrings and the quads at baseline and at month three and what they found was absolutely no difference between the groups five patients in the isotretinoin group did

Complain of myalgias but they were no different from their own baseline nor from the folks who are not on isotretinoin so the authors concluded that although the muscles may be sore to touch that there’s no physiologic reason to assume that there will be a decrease in athletic abilities unless the patient’s because of the discomfort are guarding and not performing

Up to task there’s also been a flurry of frequency of laboratory mat monitoring studies this first saw looked at a systematic review of 61 studies found a statistically significant change in the mean value of the white blood cell count and hepatic and livered panels not surprisingly the proportion of patients however would these abnormalities was very low and the

Mean change did not reach any kind of level that they would have been concerned the interesting facts in this paper was that there was no difference between the blood tests at week eight and the blood tests at week 20 and the office concluded therefore that perhaps all we need to do is baseline and month one and two and stops doing blood tests after that unless

Of course there was an abnormality earlier on another single center review of lab data looked at 515 patients who had taken 574 courses of isotretinoin they found that clinically insignificant decrease in white blood cell count and platelets and the transaminases although increased slightly were infrequent and not statistically significant they also saw as with

Most studies an increase in statistically significant increase in triglycerides and cholesterol but the interesting thing was that it took almost two months for those elevations to become significant so their conclusion was there’s no need to check a white blood cell count there’s no need to check labs until two months you can skip that one month mark and you may

Need to check may not need to check it beyond two months the most recent by webster at all was a retrospective chart review of 246 patients seen over a period of nine years standard increase in cholesterol triglyceride but the interesting facts in this study was that 35 of the patients had an elevated ast but they all also had an elevated ck 32 had an increase in

Alt but 11 also had an increase in ckd now we know that ast and alt are not liver-specific they’re also found in muscle and red blood cells and if the sample hem eliza’s the red blood cell releases them and it looks as if there’s a hepatic abnormality ck on the other hand is muscle-specific so an increase in ast in this study was always associated with an increase

In ckd suggesting that it was a muscle source not hepatic ggt on the other hand is more livers is completely liver-specific it’s also not elevated less the sample become hemolyzed in this study there was only 13 patients with a ggt kind of an encouraging increase in amount five were isolated eight also had an elevation in alt and ast but only two were associated

With an increased vk the ck was increased in a lot of patients as you can see here especially in guides us recognizing of course that what we’re looking for is a statistical outlier it’s all well and good that the mean looks as if we don’t have to check blood tests but we’re looking for that one patient sitting in front of us and their laboratory of values but be

That as it may the tests do suggest that we don’t have to monitor past two months that we may not do need to monitor at the one month mark we now have four studies if everybody is keeping track including the same study from 2006 that suggests that cbc’s are unnecessary to evaluate to replace the alt in the ast with ggt monitoring and make sure you’re checking ck

Especially if you live in morristown new jersey thank you very much for your attention

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Oral Isotretinoin Important Considerations By Skin Laser