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.
I am so thankful that I found Chad because:
I am so thankful that I found Chad because:
1 Comments:
Aww, that post is really sweet! I love when Chris calls me beautiful instead of hot. Sometimes I have to remind him that hot isn't really a compliment much anymore these days. I'd much rather be beautiful than hot. I love that picture too! Your dress is beautiful (at least from the back LOL!)
Have a great weekend!!
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