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first trimester tetratogenicity "likelyhood"?
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first trimester tetratogenicity "likelyhood"?

i read the blogs,mfg info and warnings against pregnancy,the registry and 3rd party opinions. but no where do i see,based on pregnancies "known" to date,what the "likelyhood" that a full term pregnancy will result in birth defects,or that miscarriage will occur.just a lot of extrapolating,pontificating,speculating.after all,this med has been used for some time now,pregnancies have occured,babies have been born(or not).any resources showing real time, "to date" data links would be appreciated. i have a family member,3 weeks in treatment,now pregnant.
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Avatar_f_tn
Often it is not necessary to have actual cases to know that a chemical is toxic to a developing fetus.  
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Avatar_m_tn

Ribavirin dosing label states categorically that the drug "may " be harmful to the fetus" .If your family member chooses to ignore drug warnings ..that would be a personal choice.I don"t believe many others would take that risk in such an important matter.
I don"t personally know of anybody that had a child with birth defects from doing HCV therapy .. but that is more than likely because you would think most people adhere to the danger warnings. and not experimenting otherwise....
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446474_tn?1404424777
You should tell your relative " Patients should be advised to notify the healthcare provider immediately in the event of a pregnancy".

This is a very serious issue  "ribavirin may cause birth defects and/or death of the exposed fetus" to quote from the ribavirin package insert.
It doesn't get much clearer then this.

From the package insert on Incivek...

http://pi.vrtx.com/files/uspi_telaprevir.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INCIVEK safely and effectively. See full prescribing information for
INCIVEK.

• Pregnancy: Use with Ribavirin and Peginterferon alfa: Ribavirin
may cause birth defects and fetal death; avoid pregnancy in female
patients and female partners of male patients. Patients must have a
negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception, and undergo monthly pregnancy tests. (5.1, 8.1)

5 WARNINGS AND PRECAUTIONS

5.1 Pregnancy: Use with Ribavirin and Peginterferon Alfa
Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Because INCIVEK must be used in combination with peginterferon alfa and ribavirin, the contraindications and warnings applicable to those drugs are applicable to combination therapy. Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during treatment and for 6 months after all treatment has ended. Female patients should have monthly pregnancy tests
during treatment and during the 6-month period after stopping treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients as significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin [see Contraindications (4), Use in Specific Populations (8.1), and Patient Counseling Information (17.1)]. Refer also to the prescribing information for ribavirin.
Female Patients
Hormonal contraceptives may be continued but may not be reliable during INCIVEK dosing and for up to two weeks following cessation of INCIVEK [see
Drug Interactions (7)]. During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception.
Examples may include barrier methods or intrauterine devices (IUDs) [see also Use in Specific Populations: Pregnancy (8.1) and Patient Counseling Information (17.1)]. Two weeks after completion of INCIVEK treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control; however, specific prescribing information recommendations should be followed for the contraceptives.

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Because INCIVEK must be used in combination with ribavirin and peginterferon alfa, the contraindications and warnings applicable to those drugs are applicable to combination treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
Pregnancy Category X: Animal studies have shown that ribavirin causes birth defects and/or fetal deaths while peginterferon alfa is abortifacient [see Contraindications (4) and Warnings and Precautions (5.1)]. See the prescribing information for ribavirin.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant [see Contraindications (4),

Warnings and Precautions
(5.1) and ribavirin prescribing information]. Interferons have abortifacient effects in animals and should be assumed to have abortifacient potential in humans (see peginterferon alfa prescribing information).
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment. Systemic hormonal contraceptives may not be as effective in women while taking INCIVEK.
Therefore, two alternative effective methods of contraception, including intrauterine devices and barrier methods, should be used in women during treatment with INCIVEK and concomitant ribavirin [see Warnings and Precautions (5.1)]. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Health care providers and patients are encouraged to report such cases by calling 1-800-593-2214.

INCIVEK (telaprevir) Tablets
Pregnancy Category B: Telaprevir treatment alone in mice and rats did not result in harm to the fetus. The highest doses tested produced exposures equal to 1.84- and 0.60-fold the exposures in humans at the recommended clinical dose, respectively. Telaprevir treatment alone had effects on fertility parameters in rats. The no observed adverse effect level (NOAEL) for testicular toxicity was established at exposures 0.17-fold the human exposures at the recommended
clinical dose. Potential effects on sperm (e.g., decreased % motile sperm and increased non-motile sperm count) were observed in a rat fertility study at exposures 0.30-fold the human exposures at the recommended clinical dose. Additional effects on fertility include minor increases in percent preimplantation loss, in percent of dams with nonviable embryos and percent of nonviable conceptuses per litter. These effects are likely associated with testicular toxicity in male but contributions of the female cannot be ruled out. There are, however, no adequate and well-controlled studies in pregnant
women. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients—both during treatment and for 6 months after the completion of all treatment.
INCIVEK combination treatment should not be started unless a female patient has a negative pregnancy test immediately prior to initiation of treatment.
Pregnancy testing should occur monthly during INCIVEK combination treatment and for 6 months after all treatment has ended [see Contraindications (4)
and Patient Counseling Information (17.1)]. Pregnancy testing in non-pregnant female partners is recommended before INCIVEK combination therapy, every month during INCIVEK combination therapy, and for 6 months after ribavirin therapy has ended.
----------------------------------------------------------------------------------------

Cheers!
Hector
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446474_tn?1404424777
From the Copegus package insert

http://printfu.org/read/copegus-ribavirin-usp-tablets-a11a.html?f=1qeYpurpn6Wih-SUpOGumaenh6--xqq7vbiQmtvX1sfr1tfV3aKFybu1mZK9r7ayusG4jqrpn6aih-Tmi6nnoKaen47Z69jo1dXAws7a2Yiw4J-dqZjLlqPYqqedqJbO6eHVpp6l3Ovfk9ng3dPmzNrf1Nqd7dij2MnWoazd5Mvc4tjLwd_H1d7O4tvXzbqqtpvV0NWYoPE

COPEGUS (ribavirin) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (see WARNINGS).

...Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may
persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after
completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Information for Patients, and Pregnancy: Category X).

Pregnancy

Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin has
demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of
the recommended human dose of ribavirin. COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO PLANNED INITIATION OF THERAPY. Patients should be instructed to use at least two forms of effective contraception during treatment and for 6 months after treatment has been stopped. Pregnancy testing should occur monthly during COPEGUS therapy and for 6 months after therapy has stopped (see CONTRAINDICATIONS and PRECAUTIONS: Information for Patients and Pregnancy: Category X).

Information for Patients

Patients must be informed that ribavirin may cause birth defects and/or death of the exposed fetus. COPEGUS therapy must not be used by women who are pregnant or by men whose female partners
are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners
of male patients taking COPEGUS therapy and for 6 months posttherapy. COPEGUS therapy should
not be initiated until a report of a negative pregnancy test has been obtained immediately prior to
initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months
posttherapy.

Female patients of childbearing potential and male patients with female partners of childbearing potential must be advised of the teratogenic/embryocidal risks and must be instructed to practice
effective contraception during COPEGUS therapy and for 6 months posttherapy. Patients should be advised to notify the healthcare provider immediately in the event of a pregnancy (see CONTRAINDICATIONS and WARNINGS).

Hector
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Avatar_m_tn
I agree her doctor needs to know asap....... Not that it matters but you say shes just now into her third week of tx.... Since she knows she is  pregnant i take it she was before she started tx. Did she not tell her doctor there was that chance? And did her doctor run a test before hand?
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179856_tn?1333550962
IF she was not notified by her doctor of this it seems to me she should contact a lawyer. I dont know how you prove something like that but it's very, very wrong.......and her OBGYN should be extremely involved.

Jesus.
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Avatar_f_tn
Frankly, I have to express some chagrin at the seeming non-chalance of the poster.  Why would anyone want to tempt fate like this?  I would again emphasize the last line of Hector's post PATIENTS SHOULD BE ADVISED TO NOTIFY THE HEALTHCARE PROVIDER IMMEDIATELY IN THE EVENT OF A PREGNANCY.  Why waste time searching for "studies" to disconfirm what one has been told?  At this point getting her to a health care professional is critical.  Securing the health of the mother and preparing for the child's birth and all the special needs it might have would be pretty important at this point; don't you think?
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179856_tn?1333550962
I thought so too but if the doctor didn't mention it and then the person found out afterwards perhaps it's not so non-chalant as it first appears.

Which is why I asked them to pull my first post I have no idea what the situation really is and reading between the lines on the internet is a sticky thing and often completely incorrect.
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Avatar_f_tn
I am not sure that physicians should always be made responsible for patient's oversights like this.  Package labels, pharmacists and, by now, most everyone should be refined enough to know about protecting a pregnancy.  Sounds to me like this was accidental.  The idea of making a physician pay for such accidents boils my blood.  This is one of the reasons why health care costs are so outrageous.    
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Avatar_m_tn
Well not ever being pregnant :) I ask some girls in the office if it was possible to know if you are after only 2 weeks, after they said they really doubt it they started to congrat me and my wife..... So then i assured them it was not my wife, wouldn't be possible for her so then they wanted to know if i was some kind of a pig or summin...... YIKES
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Avatar_m_tn
Not to quick to give the doctor a pass on this, its their job to warn people of the dangers of these meds and IF h/she didn't them thats not right.
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179856_tn?1333550962
Not everyone yet realizes that their doctors aren't God because many doctors act as if they are and want their patients to think that they are.  

Most people just stumble in blindly and take whatever the prescribed thing is and never think to look anything up. I did the same thing before this disease made me obsessive, how many friends now make sure to get all their lab reports because I've hounded them for so long - and they get so excited when they see something and go "hey look my cholesterol is down" or some such thing.

When it comes to pregnancy and a child's birth defects I think the doctor is OBLIGATED to make sure the patient thoroughly knows and understands just how dangerous this can be.  If they don't then they are at fault morally ethically and every other which way they can be held culpable in my opinion.

We're not talking something trivial here.

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179856_tn?1333550962
i was some kind of a pig or summin"

Uh do you really want me to answer that one Seymour my dear friend?   ;)
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Avatar_m_tn
Oink Oink...........:)
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179856_tn?1333550962
Squeeeeeeeeeal you know I'm right there with ya!  ;)
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Avatar_f_tn
I think we are going way out there and almost assuming that there was no in office education re the infection and the treatment.  It almost feels like we are all too ready to pin it on the doc.  She was already pregnant when she started treatment evidently and just found out.  Perhaps she didn't pick up her meds. right away from the pharmacy.  Is the first dosing always in the office?  If not, she could have started her treatment any time after it was prescribed.   It wouldn't have happened in my trial because all women of child bearing age have to get pregnancy tested throughout and we have to take the medicine right in front of the coordinators.  But of course, doing things this way costs the drug companies millions and guess who then pays for these cautions when the drugs finally hit the market?  I just read where a woman who had HepC donated a kidney to her husband.  Sure the hospital is responsible for not double checking but Duh!  Was the woman sleeping under a rock?  According to the article, she was well aware that she had the virus!!! And now they are both suing the hospital!   And what about the case of the woman who said she got HepC from a former prison inmate and sued because the prison should have identified and treated the infection.  What about the ex con?   Doesn't he have a responsibility?  What about her, doesn't she?  This is your next years taxes friends and your next years health care bill, deductible on insurance, co insurance etc.  There are an awful lot of people who just want to stick their heads in the sand about this infection and pretend that it is not there so they don't protect themselves and don't take precautions.  This is not the only disease or malady where people do or don't do such things.  The people on this forum are, it seems, a rare breed who not only want to stay informed but who are courageous enough to treat, sometimes over and over if they have to.  Still, the general public needs to assume some responsibility for monitoring their own behavior and health care.  By the way, ethics, malpractice and incompetence have different meanings.  Mistakes may be grounds for a malpractice suit but they do not necessarily constitute unethical behavior.  It may be unethical to double charge a patient and an insurer but that is not malpractice etc.  Just a vent.  
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179856_tn?1333550962
that the physician is (under the law) a "learned intermediary" between the pharma company and patient and is responsible to determine if the patient has any contraindication, such as pregnancy, before prescribing the meds

From a top notch Doctor of law directly.
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419309_tn?1326506891
Ribavirin's pregnancy warnings exist because of an increase in birth defects in certain laboratory experiments, specifically in hamsters and mice.  It appeared to interfere with the embryonic development process in certain lab animals; however, ribavirin is not cytotoxic. Nonetheless, your family member should be recommended by her OB to have a targeted anatomical ultrasound to address the medication exposures.

Thus far, there have been no documented cases of birth defects or miscarriage as a direct result of Riba administration; case reports actually document women and men who had successful pregnancies despite riba exposure:

http://onlinelibrary.wiley.com/doi/10.1002/bdra.20682/abstract

Hope that helps, and best of luck you your family member.
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Avatar_m_tn
Thus far, there have been no documented cases of birth defects or miscarriage as a direct result of Riba administration;...

......unless of course you give birth to a hampster :)
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Avatar_m_tn
"......unless of course you give birth to a hampster :) "

Is there something up there in the water that causes that???
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Avatar_f_tn
Okay don't get me wrong here sex is great and everything but how about just not having sex for a little while. I mean it's only about a year of a persons life without. For me personally I would rather give it up for however long it took to get treated then to bring a child into the world knowingly or on accident with any kind of birth defect. Because most likely that child will have to struggle most of thier life to even try to live a somewhat normal life. Children are one of the most wonderful blessings that the good Lord can see fit to give us and it is our duty to give them the best start in life that we possibly can. But that's just my opinion.                  Jen
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419309_tn?1326506891
For me personally I would rather give it up for however long it took ...then to bring a child into the world knowingly or on accident with any kind of birth defect...
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I think it will take considerably longer than any of our lifetimes to prevent accidental birth defects... your duty of abstinence is how long?  
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Avatar_f_tn
Eureka you didn't take my complete thought there you only took part of it. Birth defects happen it's just a simple fact of life. I just think that if there is something that we can do to prevent it from happening we should do that. You make abstinence sound like a bad thing when in fact it can be very good for you in many ways. It can give you a chance to grow spiritually, mentally,and emotionally. This world that we live in is very harsh and unforgiving and everyone deserves the chance from the first day they are created to have the best possible start in life. I have had many friends in my life that had various disabilities. There were always nights that I would cry myself to sleep because of the pain that I had seen my friends endure. So for me this is no question abstinence is the only option for me right now. As far as how long it will last. Like I said before as long as it takes to know that if I happened to get pregnant I would be able to give this child the best possible start in life. Jenn
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Just one more thought here. I don't plan on abstaining forever just until I've finished and recovered from treatment and of course until I am able to reach SVR. Also until I find someone that I feel like I could raise a child with since the last person turned out to be a real winner and I'm now raising 3 children completely on my own. Jenn
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179856_tn?1333550962
We knew what you meant lakegirl.  :)

Also, I raised two kids on my own I know all about those winners...they seem to be everywhere don't they?
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419309_tn?1326506891
It did sound like the initial poster's family member got pregnant before starting treatment and just found out; the question appeared to be about exposure after unexpected conception, not about abstinence during treatment, so I thought your initial post was a bit over-the-top.  

Yes, birth defects are a simple fact of life -- so you do realize the only sure way to prevent any, accidental or otherwise, is to not get pregnant. In fact, there are people who have no children because they feel that way.  I'm very glad that you have three healthy children, but realize that for some couples, birth defects in their children is a reality in life and abstinence is their only 100% prevention, so unless you do plan on abstaining forever (and if you do, I'm not saying that's a bad thing, some people make that personal choice too), your statement seemed to be a bit cavalier about "however long it takes."

I guess the question you might mull over is, if someone had a crystal ball and told you your next child will have a severe birth defect, would you abstain for life? Just a thought.  
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568322_tn?1370169040
We don't know what the likelihood is since the number of reported cases is small and some of the women chose to terminate the pregnancy.  I do know one woman who got pregnant during the last month of treatment.  She had a spontaneous abortion during the first trimester.

Here's a few more cases....

http://www.sciencedirect.com/science/article/pii/S0890623805001656

http://www.ncbi.nlm.nih.gov/pubmed/17698320

http://www.ncbi.nlm.nih.gov/pubmed/3367344

Co

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