a warning for the ladies

posted by sometrouble @ 4:41 PM | Test Category Two | Wednesday, August 02, 2006

Disclaimer: The following LENGTHY (sorry) post relates to oral contraceptives and will probably only interest female readers. Male readers feel free to read...just consider yourself warned. (although, I'm not even sure that I HAVE any male readers.)

For anyone who is taking a pill called TriNessa, I believe you should seriously rethink it. I recently found several pieces of information relating to this drug that alarmed me. TriNessa is one of the generic "equivalents" of Ortho Tri-Cyclen. I put that in quotes, because I can't seem to get an explanation of what that word "equivalent" means. I always believed that generics were exactly the same as the brand name drug (and that they had to be in order to be a valid substitution). But after reading many patients' comments on www.askapatient.com regarding being switched to TriNessa, I wonder if that is actually true.

Basically, many many women claimed that they had either none or very minor side effects when they were on Ortho Tri-Cyclen (OTC) and for whatever reason were switched to TriNessa. They report many horrible and suddenly occurring side effects. Some of the side effects the women report are:
mood swings, weight gain, "severe and constant back pain and/or crushing chest pains," depression, lack of energy, loss of libido, acne breakouts, night sweats, allergic reactions not experienced with the brand name, cramps, hot flashes, dizziness, migraines, major fatigue, and muscle weakness.
I know these are common side effects listed for many birth control pills, but these women reported having none of these symptoms when on the brand name "equivalent."

Samples of the accounts listed on the site:
I, like many of the others on here, was taking OTC when I was switched to Trinessa. After taking OTC for severeal years, my cycle was normal, and I was usually very even-tempered. After taking Trinessa I feel my life and body are out of balance. The mood swings I have experianced are unbeliveable, and my libido has all but disappeared. Trinessa is ruining my marriage and my social life.
One woman writes in:
I talked to my Doctor, who specializes in internal medicine, and she said that the generic form is not EXACTLY the same. She said that they are the same drug but have a different make-up.
Another says:
Generic forms are not the same. Do not take Tri-Sprintec. I have a rash, haven't slept much in days and I have pimples for the the first time in years. I am waiting for the pharmacy to open so that I can switch back to Ortho Tri-Cyclen.
Yet another reports asking her doctor:
I had major fatigue and muscle weakness and sometimes had chest pains as well. I talked to my Doctor and she said to take the brand name only when it comes to hormones.
You can read the LONG page of complaint after complaint related to Trinessa versus Ortho Tri-Cyclen. But here's the real kicker...

TriNessa was RECALLED in February of this year. The recall record and reason came out on the Food and Drug Administration's website about a month later. See it here (scroll about 1/3 of the way down the page to find TriNessa)
REASON
Subpotent: The active Norgestimate component of TriNessa tablets fails stability assay.
I can't explain the method they use for their stability assay...but as a scientist, I can tell you that is a big deal. Apparently they thought so too...because they recalled 1,383,709 six packs of the stuff. If you take TriNessa, and especially if you order through prescription mail order where you get several packs in advance, you should compare your lot numbers and expiration dates with those on the report. www.askdocweb.com explains with regard to the "stability assay"
What that means for you is that the hormone levels were not high enough and some women have become pregnant on it...Some lots had hormone levels that were not at their expected potency levels (not strong enough to prevent pregnancy). The affected lots have been pulled off the shelf and replacement product is now back in stock.
In addition...doing a small search, I uncovered the following women posting in a forum on www.aphroditewomenshealth.com:
Julia:
Hello everyone. I switched from Ortho TriCyclen to Trinessa in early February and was never informed of a recall by my pharmacist or my doctor. I wasn't even told in March when I refilled the script. When I finally found out about the recall (in April), I noticed that I had gotten a batch from the recall list in March and I'm assuming in Feb. I threw out the empty Feb case not knowing anything. Well, I'm pregnant now (about 11 weeks) and, although I am very happy, Im upset at the way this whole thing happened! I believe my Pharmacy is to blame. Am I wrong? Does anyone know if I can take legal actions here? Please let me know if you can. Thank you.

mclissa:
I also was on the pill trinessa. On 2/10/06 I recieved a phone call that the pill was recalled. I found out i was expecting 1 week prior to the phone call. I contacted Watson diretly and they said that the pill was recalled b/c the hormone levels in certain lots were lower than stated on the package. If you call their 1800 number they will answer any questions that you may have.

morgan26:
I am very upset i went to refill my pack and they told me it was recalled, when i found out, i went to the doctor and i found out i was prego i need help and i want to know what can i do about it!!!!

Libby1:
So many getting pregnant on TriNessa- I was taking it and got pregnant and was taking my pills are the correct times etc. I am looking into a class action suit. I have high risk pregnancies and wasn't planning on more children.
I also found this one report from November of 2004, well before the recall on www.experts.about.com.
I am married, 31 YRS old and have 2 kids. The first day of my last period is irrelevant at this time. I am pregnant. In March or April of this year I switched BC pills from ORTHO TRICYCLEN to TRINESSA which is the generic brand and cheaper brand. I am now 21 weeks pregnant and so far during this 21 weeks I have learned of 4 other women who got pregnant on this pill. I know for sure 4 of us were not on any antibiotics (which could lessen the effect of the pill working). 4 of us were also done having children and were faithful to taking the pill everyday at the same time-none being skipped. My question is, has anyone else experienced getting pregnant on this pill?? I live in a city of 50,000 people and this is 5 women in a 20 mile radius. Anyone else have this happen on this pill??

The expert answers:
I am unfamiliar with a pill called "Trinessa". You always have to be careful when using generic medication. Your best bet is to write to the manufacturer and see if there are any reports of failure rates with that medication. If you get no satisfaction from the manufacturer, I would write to the FDA and lodge a formal complaint.
I had decided to switch and pay the $20 copay for OTC versus the $10 copay for generic. My doctor had written the prescription for OTC, but my pharmacy had just substituted the generic. This is another thing to watch out for. Many pharmacies will substitue unless the doctor writes DAW meaning "dispense as written" or unless the patient requests the brand name. The problem is...when I requested the brand name, they told me it would be $40. The $20 copay only applies to brand name medicines if the doctor specifically calls for brand name only, or if there is no generic equivalent. If the patient requests that they be given the ACTUAL medication they were prescribed, then they have to pay whatever the insurance company won't cover, in my case the insurance was going to cover $15.

It is still up for debate whether generics are the same as brand names or not, I have formed my opinion leaning towards them not being. Even if they are composed of the same things, there is a reason they are provided cheaper...and with medication I am counting on to keep me baby-free, I don't know if I trust a "cheap" manufacturer with a history of not putting in enough hormones to make the stuff work! I just think it is ridiculous that a pharmacy can substitute without your permission...and many times, without even telling you, something as important as medication. Then, if you want to do something about it, and GET WHAT YOU WERE PRESCRIBED, they smilingly tell you that it will cost you more. "Unless the doctor says so"...well didn't the doctor write the freaking prescription on purpose a certain way in the fist place?!?!?!

I was fuming after I wasted my entire lunch break standing at the drug store trying to sort out what I thought was a case of the insurance not covering me for who-knows-what reason. What are your thoughts on the whole generic versus brand name drug thing? Think they're the same or not? Let me just say that outside of prescription drugs like these, I could care less whether most things were brand name or store brand. But I'm not messing around with Trinessa anymore.

15 Comments:

At August 02, 2006 10:51 PM, Blogger Numine said...

Justin's in nursing school and he'll give you his educated opinion in a few minutes (I told him to read your post).

Speaking from experience, I have been on Cryselle, which is the generic of Lo-Ovral, a lo-dose oral contraceptive, for four years. I was originally on Ortho-Cyclen and switched to Depo-Provera (the shot) after OC killed my libido. Depo-Provera was FAR too high a dose of progesterone for my system to handle and I subsequently became menopausal (hot flashes, no periods, sleep problems, EXTREME depression) for three months. It was after this that I switched to Lo-Ovral.

Initially, I believe I was on the brand name pill. At some point they started giving me the generic. I never noticed a difference and my results have been superb. I have no complaints about Cryselle or its effects on my system although I do, on occasion, wonder what it'd be like to have a hormone-free sex life. As my last pack expires (I know this term means nothing really) in August, I'm going to talk to my doctor about ParaGard, the hormone-free copper IUD.

 
At August 02, 2006 11:12 PM, Anonymous Justin said...

Wrapping up pharmacology class this quarter...good times. But on to the discussion.

Here's how the drug system works. A company (Ortho-McNeil Pharmaceuticals in the case of Ortho-tricyclen) invests a large amount of money and time developing a drug, testing the drug in clinical trials and then marketing the drug. Once the drug is approved it goes to the official naming agency that names all new drugs and the drug is named, in this case, the name is actually "norgestimate/ethinyl estradiol", that's the generic and official name. The company then is awarded their patent, and they can call the drug whatever they want for the purpose of marketing, it's usual catchy...Ortho Tri-cyclen...Viagra...Lipitor. They get exclusive rights for a while and after that, anyone else who can synthesize the drug can market it under whatever name they choose, again, that's their trade name...in this case, Trinessa.

Is it possible for a generic drug to be different from a brand name? Technically no. Just as one molecule of water, however it's made, is indistinguishable from another molecule of water, one molecule of norgestimate is the exact same as any other. Technically they're using a specific type and isomer, but both drugs call out the exact same isomer on their prescription sheet, it's impossible for the two chemicals to be different. Just as two molecules of gold can't be different.

Is it possible that a manufacturer cuts corners and they're synthesis/manufacturing is sloppy so that they're not actually making the chemical? Yeah...in theory, and that may have been the reason for the recall. Someone may have noticed the problems and when they checked their reactors they noticed they were running 2 degrees hot which might not result in the proper yield, so the pills wouldn't actually have the right chemical concentration in them. It's not possible to have two identical chemicals that have different stabilities, so if they recalled, they probably were screwing up their synthesis and not producing proper yield.

But the very definition of a generic drug is that it MUST be identical to the actual drug. Looking over these two drugs (in this case) on their respective manufacturing specs shows the chemical make up is exactly the same, all the way down to the dye used in the inert pills. So from an industry standpoint, a Dr. who tells you a generic is different from a brand name doesn't understand their pharmacology or how the FDA works. Is it possible that someone is cutting corners in the manufacturing process? Sure. But the reduced cost of the generic isn't because of cut costs, it's because they never had to pay R&D, clinical trials, marketing, etc. They don't have to recoup those costs (which are massive), so they can charge much less. They don't need to do that research, because someone else already figured out that 18,19-Dinor-17-pregn-4-en-20-yn-3 one, 17-(acetyloxy)-13-ethyl-,oxime,(17a)-(+)-) works as a birth control, and that person had to document a synthesis for it, and following that synthesis yields the chemical. Voila.

 
At August 02, 2006 11:16 PM, Anonymous Justin said...

p.s. Identical chemical also includes the same amount. So both blue pills contain .250mg of norgestimate, etc.

Again, I can't speak to manufacturing techniques, but officially they cannot make a generic any different from a brand name, that's illegal and if they have a situation where that's the case, they have to recall and show that they are producing an equivalent drug.

 
At August 03, 2006 10:07 AM, Blogger sometrouble said...

numine: I was taking ortho tricyclen lo first...and it was not giving me too many mood affecting side effects, however the dose of ethinyl estradiol (0.025 mg) was too low for me, and I had breakthrough bleeding for three months. That was when i switched to TriNessa. I had been on ortho tricyclen regular before, and it made me nauseated frequently. But the TriNessa seemed ok for the first month. My mom used to take Ortho-Novum 7/7/7, and she seemed clueless when I was mentioning side effects such as depression, nausea, anxiety, loss of libido, etc. She claimed she had NO adverse effects when she was taking it. I am a little too chicken to try Depo, a friend of mine was thinking of using the Mirena IUC.

Justin:
Thanks for the explanation, it was really interesting. I had always thought the drugs had to be the same, and I did print out the full prescriber information and compare, and all seemed the same. I see what you mean about the cutting corners factor...but that would not produce a product that has been working properly but producing vastly different side effects to it's brand name counterpart. It would, like you said, not produce the same molecule and therefore need to be recalled. I just don't know if I trust a pill made by a company that had to recall that much of their product...I know it could happen at the brand name lab too...but until it does, they hold slightly more of my trust. Like I said, I saw none of those horrible side effects reported to be associated with TriNessa and not with Tri-cyclen, but I only took triness for a month. I guess I will compare it to next month on tri-cyclen.

 
At August 03, 2006 10:12 AM, Blogger sometrouble said...

p.s. to Justin... YAY! I have at least one male reader...even if it's just for the most "estrogen containing" post! LOL!

 
At August 03, 2006 5:18 PM, Anonymous Justin said...

Consider this possibility:
You run your reactor a bit hot because someone isn't checking the gauges regularly and as a result you end up with a fine white powder at the end which looks like what you expect. You make it into pills and ship them out. The probem is that by running the reactor too hot you got 90% of your desired product (18,19-Dinor-17) and 10% of an undesired side reaction product (say 16,19-Dinor-17). I saw this sort of problem all the time while working with polymers in my Masters program. You'd run a synthesis and instead of getting a clear green polymer it was sort of opaque. Did I follow directions? Yeah, but if you don't control the reaction just right these complicated synthesis will run side reactions, it's incredibly hard to control (and the challenge in creating a large scale industrial synthesis).

I would not be surprised to find out that someone didn't read the gauge every hour like they were supposed to...or some operator with a 9th grade education didn't think that 454 degrees Kelvin was far enough off 456 degrees Kelvin to mention it to his supervisor. Little errors like that could easily yield side products, and it's likely those side products that would cause your adverse reactions.


But how could the drug still work and yet yield different side effects you ask? Scenario: With the side reactions you end up with .230 mg (instead of .25 mg) of your drug and .02 mg of side product. Well maybe it turns out that .2 mg of drug is plenty to suppress ovulation, so the drug stil works...you just have .02 mg of side product on board which may or may not have any noticable effects. Not as uncommon as you might think. The research on aspirin preventing heart attacks used 100 mg doses and got great results. But aspirin is commercially available in 82mg and 325mg tablets...oops. So 82mg is too little, so in the hospital we tend to give 325mg to make sure we're at the therapeutic threshold (325mg is still well below toxicity). So imagine that the aspirin we're buying got mucked up in the reactor and only has 300mg of aspirin and 25mg of side product. We'd still get the desirable drug effect, because we're well over the therapeutic dose of 100mg, but we might get side effects we haven't seen before because of those 25mg of side products.

Side products happen all the time in the industry, it's just that in most cases they're in small enough amounts (or completely inert) that it really doesn't matter. When they say a pill has .250mg of drug, what that really means is that a statistical analysis of any given pill will yield an amount of drug that is statistically equal to .250mg allowing for margin of error. But with most drugs we have what's called a ED50, the dose that is effective in 50% of those who receive the drug. So drug formulations are based strictly on statistics. .250mg is probably way more than a lot of people need (statistically speaking most people probably need something like .2mg) but the extra .05mg is added to take care of the outliers, those people who would not be amongst the 50% who respond to the ED50. So if we lose some product, most people are still covered, except unlucky patient #98. And everyone may end up with side effects...even if they're not pregnant.

 
At December 18, 2006 11:57 PM, Anonymous Anonymous said...

I started out on Ortho Tri-Cyclen, and had terrible mood swings. I kept taking it for about eight months, before asking the doctor if there was anything we could do. She switched me to Tri-Nessa, and the change was literally immediate. I was no longer screaming at my husband and crying all the time... I guess everyone is different, but I was far far worse on the supposed "good stuff"

 
At July 24, 2007 4:34 PM, Anonymous Anonymous said...

Has anyone had seizures after taking this birthcontrol? My 18yr daughter started Trinessa and within three weeks (April 07), had a seizure. She didn't stop the bc, but just had another seizure three months later. After that one she stopped Trinessa. Now we have to go through all kinds of tests for seizures.

 
At August 04, 2007 12:36 AM, Anonymous Anonymous said...

I am 21 years of age and have never taken birth control. I am sexually active with my boyfriend, I've always had nice clear skin for the most part--maybe a pimple or two a month but my periods are out of this world! They are extremely heavy for 4 days and then light for 3 and then I spot for 3 more days. I started taking Trinessa 2 weeks ago when I had my period. I havent stopped bleeding but for the last 7 days its just heavy spotting, enough to annoy the heck out of ya! My face isnt breaking out but my 1-2 pimples are more like 4-6. All day and night for the last 24 hours I have read so many negative stories about the BC and very few of them with ladies stating of no major problems. After reading so many stories im so scared to continue taking Trinessa. And I know that every woman's body is unique so you have to find the best BC for you but I'm worried that Trinessa isnt the best, especially since ive had my period for the last 15 days. Also, im worried I started Trinessa wrong. I read in the instructions you could take it 2 ways. 1 way is to take it the Sunday after you start your period. The 2nd is that you can take it the first day of your period. Because I was so excited about taking a BC to help tame my wild periods I took it the first day of my period. Did I do something wrong? Someone educate me please :(

 
At February 11, 2008 11:58 PM, Anonymous Anonymous said...

i am so glad i found this website and read justin's posts. he needs to post his educated opinion more places. i hope that people take their medications seriously enough to print out lists of the ingredients in both the generic and brand-name drugs and compare them with a highlighter. they are identical, and though batches may vary, there is no way to account for the exaggerated symptomology "women" have posted on the consumer websites (perhaps the drug companies have a hand in this?)

p.s. i first took ortho and then started trinessa five years ago and have been fine. i admit that the recalls are scary. maybe now they will pay better attention.

 
At July 26, 2009 12:59 PM, Anonymous Anonymous said...

I started tri-nessa about 2 months ago after not being on any BC, because I am getting married in 2 weeks. So far in 2 months I have experienced:
Cyclical mood swings, I get so MEAN. My fiance is NOT amused. I kept telling him just give it a few months, you are overreacting, it's just wedding stress, but I think maybe the moods are way more severe than I realize and he sees it for what it is.
Bleeding. DAILY. I go through about 3 panti-liners a day. It's not heavy, but it's thick. Gross.
The tri-nessa has also corresponded with breakouts along the jawline (I was blaming the humidity, hmmmm glad I read online that many other women experienced breakouts). I had previously had adult acne, then found the right skin care products and 100% cleared up my skin, and then bam, acne.
I'm not taking this pill anymore. Hopefully my skin will clear up before the wedding, and hopefully we won't get pregnant right away...

 
At January 30, 2010 11:31 PM, Blogger nativespirit28 said...

my friend was just admitted to the hospital with a pulminary embolizism -- she has a blood clot in the lung--- they say she now has to take coumadin for how long i don't know but this is a scare i am looking to see if there is a civil lawsuit going on any where if someone knows about one write me back at nativespirit28@yahoo.com thank you all-
christie

 
At April 23, 2011 9:53 AM, Blogger blueeyezusa said...

HI- I was 37 years old when I suffered a blood clot (length of my leg) after only taking Trinessa for a week. The blood clot broke and went into my lung shortly after being admitted into the hospital!Very scary and I am very lucky!I was on Trinessa to regulate heavy periods. Non-smoker-walked 2 times a day and was/is in great shape.I was put on coumadin after the clots and had to be checked weekly to monitor my INR-which was very hard to stabilize!If anyone has information about pending lawsuits-legal action.. please contact me-blueeyezusa@yahoo.com
My ordeal happened in June 2006-at the time I searched and searched and couldn't find any information of other people suffering from clots.I am glad I find this site!

 
At December 14, 2012 7:55 PM, Blogger isabel91 said...

Hi I'm a 21 yr old and I have been taking trinessa bc for 1 yr 6months after I had my baby. I have been reading all of the comments of the side effects this birth control has caused. I recently suffered 3 seizures in a couple of hrs. I don't have a history nor does my family has a history of seizures. I had lots of test in the hospital but they were all normal. My doctors are still shocked on why I had the seizures. I was told by my doctor to stop taking trinessa because maybe that could have beenthe cause of my seizures. Now I can't drive for 6 months and I have to keep taking medication also from that I resulted to have migrane. I would love to talk to someone who has gone thru this because I'm lost and I don't know what to do?

 
At December 14, 2012 11:13 PM, Anonymous Anonymous said...

After being on it for 1.5 years and it suddenly happening three times lately in a row, why would they jump to that being the reason? I realize it could be anything, but why would it take so long if it was the TriNessa?

 

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