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#1 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Paxil and Pregnancy-Official warnings!
I've stickied this thread since we are seeing more women who are pregnant and looking for support and answers. Listed below are the FDA and UK warnings regarding paxil.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html Agency Requiring Updated Product Labeling The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil. FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate. FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus. Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy. Women taking Paxil should not stop taking it without first talking with their physician. The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically. In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy. FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus. Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category. Additional information concerning today's announcement is available on FDA's Web site at: Public Health Advisory: http://www.fda.gov/cder/drug/advisor...tine200512.htm and CDER Information Sheets: http://www.fda.gov/cder/drug/infopag...ne/default.htm. __________________ UK Warning sent to doctors MESSAGE FROM PROFESSOR G DUFF, CHAIRMAN, COMMISSION ON HUMAN MEDICINES. 6th December 2005 CEM/CMO/2005/11 Dear Colleague, Paroxetine (Seroxat) – Safety in pregnancy I am writing to you about the safety in pregnancy of paroxetine, an SSRI antidepressant used in the treatment of major depressive disorders, anxiety disorders and obsessive-compulsive disorders. This is in light of recent discussions in the scientific and lay media about whether the use of paroxetine in pregnancy, particularly during the first trimester, may be associated with an increased risk of congenital malformations in newborns – a summary of the findings from the recent studies is attached. New data from Denmark, Sweden and the US represent a potential signal of an increased risk of congenital malformations following maternal use of paroxetine in the first trimester. However, other epidemiological studies have not supported such an increased risk. All available data are being actively investigated by the Commission on Human Medicines (CHM) and the Medicines and Healthcare products Regulatory Agency (MHRA) and, following our further investigations and discussions within Europe, if necessary new guidance will be issued. The new studies suggest that in women taking paroxetine in the first trimester the risk of birth defects in the newborn may increase from 3% to around 4% for all congenital malformations and from 1% to around 2% for congenital heart malformations. Therefore, if real, any increased risk is small and needs to be considered in the context of the potentially greater risk to the foetus that may result from the mother's depression remaining untreated. It is also important to be aware of the risk of serotonergic effects in neonates if maternal use of paroxetine continues into the later stages of pregnancy, particularly the third trimester. Withdrawal signs in the neonate include respiratory distress, cyanosis, apnoea, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying and sleeping problems. In the majority of cases the complications begin immediately or soon (<24 hours) after delivery. Advice to prescribers: Paroxetine should only be used in pregnancy when strictly indicated and only if the benefits for the mother are thought to outweigh the potential risk to the foetus. Until this issue is further investigated, consideration should be given as to whether paroxetine is the most suitable SSRI to be used in pregnant women or those planning to become pregnant. If a decision is made to stop paroxetine treatment this should be done gradually over a period of several weeks. Abrupt cessation can cause withdrawal symptoms (most commonly dizziness, numbness and tingling, gastrointestinal disturbances, headache, sweating, anxiety and sleep disturbances), which can be severe in some patients. Advice to patients: Women taking paroxetine who want to become pregnant are advised to discuss the balance of risks and benefits of continued treatment with their doctor. Pregnant women who are currently taking paroxetine should not stop their treatment but should discuss their treatment with their doctor or midwife at their next routine appointment. Please report any suspected adverse reactions to paroxetine via the Yellow Card Reporting Scheme to the CHM/MHRA For further information please call the Medicines and Healthcare products Regulatory Agency on 020 7084 2000 or visit the website (www.mhra.gov.uk). Yours sincerely, Professor Gordon Duff Chairman, Commission on Human Medicines
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#2 |
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Join Date: Jul 2005
Location: Texas
Posts: 13,811
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Re: Paxil and Pregnancy-Official warnings!
I want to include my personal story of being on Paxil and being pregnant. I'd like to start by saying that in August of 2003, I was in the best shape of my life, happy, healthy and well-loved. My husband and I had been trying for a baby for a few months. I had no diagnosed mental health issues and had never seen a pdoc of any kind.
On Sept. 22, 2003, I felt very anxious. My pulse was racing all day long. By the time I had gotten home from work that evening, I could literally see my heart trying to beat out of my chest. Being young and naive, I didn't rush to the ER, but went to a walk-in clinic. They had a tough time even registering a blood pressure on me at all, but when they did, it was 180/130. They ran a pregnancy test which came back as positive. I got a squirt of nitro, and, long story short, after receiving a promise to go to my ob the next day, he sent me home. I did go to my ob the next day and was put on the better of the two available bp meds for pregnant women, Labetelol. By the weekend, I started having some allergic reactions to that and had to discontinue use. I returned to the ob the following Monday; again, my bp was nearly impossible to read it was so high. I was hospitalized for the first time to begin Aldomet, the other available bp med for pregnancy and so slow acting that it is given to no one else. I was released from the hospital after a few days, but a couple of weeks later my bp specialist remained unsatisfied with my progress. BTW, I was on bedrest for my entire first trimester. He added a second bp med to the mix. Within 72 hours, my bp had started on another upward spiral. I was put back in the hospital, and over the course of the next nine days would be put on three more meds. By the end of that, I was pretty sure I was dying. Words cannot express how terrible that time was, and none of the drugs were working for me at all. Finally, in a last ditch effort to save the pregnancy, my ob took me off everything except the Aldomet, put me on Paxil and sent me home. Her theory in giving me Paxil was that by reducing my anxiety, my bp would likely go down. The reality of this is certainly debatable. If I had known then what I know now, I never would have taken Paxil, but we were all desperate for any possible hope at that time. I remained on bedrest at home until I was 14 weeks. I was on Paxil and extremely high doses of Aldomet. After 14 weeks, my blood pressure issues improved steadily throughout my pregnancy. They never resolved, but there was a steady and constant improvement. This defied all expectation of my many medical advisors. Because of the high-risk nature of my pregnancy, my baby, Kate, was monitored very closely. I saw her for the first time at less than four weeks pregnant, when she was only a thickening of the uterine wall. I had more ultrasounds by 6 weeks than most women have their entire pregnancy. And after 32 weeks, we saw her weekly, for a non-stress test and ultrasound. She was always perfect. She was born at 38 weeks, perfect and healthy. I am sort of at a loss on whether or not she experienced withdrawal. I was a first time mom, so I had nothing to compare her with. She seemed to behave exactly as she was supposed to. I nursed her exclusively for her first five and a half months, so she continued to receive Paxil in my breastmilk. Complicating matters, five days post-partum, I contracted Bells-Palsy. It is a rare side effect of Aldomet use. After all that I had been through, it was pretty devastating to me. It took a good six weeks before I looked anything resembling normal again. As for me, Paxil made me gain so much weight during my pregnancy, that I could barely walk by 35 weeks. I was completely ignorant of all of Paxil's side-effects and withdrawal issues until after I stopped taking it, when I found this website. I spent a lot of my post-natal time beating myself up about things I now know were caused by Paxil. Why I couldn't lose the baby weight, why I had zero energy, why I couldn't manage to get anything done, why I was sweating so much. Worst of all, why, when I first held my newborn who I had risked my life to have, I wasn't overwhelmed by joyous emotion. Paxil stole that moment from my life. I continued to take Paxil for a little over a year more. This was completely a result of my not wanting to consult a doctor (I had had my fill for a lifetime!) about anything rather than a real belief that I needed Paxil. This is something I regret, but what's done is done. It's been nearly six months since I discontinued Paxil. It has been exceptionally difficult. Although the way in which I came to Paxil may be unique, my withdrawal experience has been far from it. This community has gotten me through. I want to finish by saying, that despite the fact that I took Paxil with no seeming lasting damage to my child, I wouldn't recommend anyone take that chance. So much more is known about Paxil and its dangers to fetuses now, that I don't believe that it would be given to me even under the same circumstances.
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Katesmom aka Kim started Paxil Oct. 2003 for PIH Paxil free since 19 Jul 2005 ". . .the cruelest lies are often told without a word. . .the kindest truths are often spoken, never heard." -- Ben Folds |
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#3 |
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"has a lavender scented keyboard"
Join Date: Mar 2004
Location: Ontario
Posts: 22,214
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Re: Paxil and Pregnancy-Official warnings!
You have been through quite the ordeal, bottom line is you are healing and have a beautiful healthy baby.
I find this to be a difficult topic to touch, so many people pregnant and finding out there is a chance that paxil can harm the baby. If the mother cold turkeys, that is a dangerous route to take as well. Personally I still feel the safest route is a slow withdrawal. I can't even imagine being in that situation, I wish that the doctors kept themselves up to date with these medications because the effects of their sloppy prescribing can effect a pregnant mom and their child for a life time.
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Rita |
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#4 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Re: Paxil and Pregnancy-Official warnings!
I'll be blunt here... the reality is that a Mom on paxil who finds out she is pregnant is probably beyond the point of preventing the possible birth defects. The goal at that point should be a slow,safe wean to be off paxil by the birth.
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#5 |
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"has a lavender scented keyboard"
Join Date: Mar 2004
Location: Ontario
Posts: 22,214
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Re: Paxil and Pregnancy-Official warnings!
I know of a mother here in Ontario who was on effexor during her pregnancy... she was one of the unlucky ones. Her son has numerous health problems as well as learning disabled. Is effexor behind it?.... probably. This warning should not be limited to paxil. These drugs are all the same!
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Rita |
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#6 |
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Join Date: Feb 2006
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Re: Paxil and Pregnancy-Official warnings!
I am physically addicted to Paxil and took it through 2 pregnancies while it was a class "B" drug. My 1st son was born 4 weeks premature supposedly due to placenta abruption, was on a ventilator for 12 hours and has lung/breathing problems and developmental problems and delays to this day (he is now 2). My 2nd son was diagnosed with severe hydrocephalus at 5 months gestation with fluid replacing his developing brain. he only had a cerebellum and would have died or been severely retarded. Feeding tube, diapers his whole life, etc... We induced early labor and let him die quickly and peacefully in my husband's arms in 5/04. We prayed the rosary with the chaplain throughout my labor and cried. The pastor didnt say we were wrong or right till he spoke to the dr and then he told my mother in law we did the right thing. My life has b=never been the same. The only thing i ever wanted to be when i grew up was a mom and I am but the most horrible thing happened. Thank god he gave me 2 other children before Vincent. It has been almost 2 years and we just decided to try to get pregnant again and found out Paxil was changed from B to C. There is no history of birth defects or pre-term labor in either my husband's or my family. We have a daughter (age 4) who was not exposed to Paxil in utero and she is 100% healthy as a horse. I am outraged and devastated. I feel betrayed. I feel like GSK's experiment. They need to be held accountable and should have never stated a drug as B(safe) when it isn't even close to that. My physical addiction is my other issue. I tried to get off Paxil with my 1st son but had "zaps" in my head and dizziness that was unbearable. I am still trying to get off Paxil to get pregnant, but it is so hard. This drug has ruined my life. The loss of my son is just unbelievable now that this drug is being exposed. I am trying to get a lawyer, but have been turned down by 2 so far. My ob-gyn records are missing the fact that I was on Paxil, making me question tampering. I have proof that I was on it during my pregnancies from my psychiatrist, pharmacy and family doctor though.
www.paxilprotest.com I WILL BE AT THIS PROTEST! they didnt announce date and time yet alison |
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#7 |
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Join Date: Jul 2005
Location: Texas
Posts: 13,811
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Re: Paxil and Pregnancy-Official warnings!
Just to be clear, in the US Paxil is now a class D drug.
I'm so sorry for all that you have been through, Alison, and understand your anger. I know just how lucky I was.
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Katesmom aka Kim started Paxil Oct. 2003 for PIH Paxil free since 19 Jul 2005 ". . .the cruelest lies are often told without a word. . .the kindest truths are often spoken, never heard." -- Ben Folds |
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#8 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Re: Paxil and Pregnancy-Official warnings!
Alison, I'm so sorry for all you've had to endure. yes, they have upgraded the pregnancy warnings recently. How did you try to wean off the paxil before?
Oh, yeah, I'll be at the protest.. went to the first one and will be at any and all that we have.
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#9 |
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Join Date: Feb 2006
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Re: Paxil and Pregnancy-Official warnings!
Thanks for your support. I did see it was changed from B to C then to D. My dr only told me there would be slight risk of withdrawl for baby, but i didnt have much choice since i couldnt get off it. At that point I hadm't tried to get off it but knew that when I missed 2 days of pills it was HORRIBLE. So i didnt even want to try while pregnant. Since then I have started welbutrin 150mg twice daily and tapered Paxil from 60 to 40 to 30 to 20 to 15 to 10 to 7? then to 5...then i felt sad and just upped it again to 20 mg with dr's approval(still on welbutrin too). This was b4 i found out about the birth defects. I really think it might be the placebo effect for me. Like I realize that I am not going to have the drug to depend on anymore, so I am going to feel sad. My depression started when my 1st child was 6 months old. I was 22 My mother died the same year and the new house we bought 2 weeks prior, the nieghbor told us there was a suicide in it. (turned out neighbor was psycho, mad she didnt get to buy this house-a woman did drink ammonia in the bathroom and then died in the hospital 1 week later 18 years ago--but for days we had ideas of gunshots, blood and gore--was terrible). Anyway, i was hospitalized for 3 days and i signed out AMA. They didnt help me. I had to tell my story over and over again to new staff on shift. I made excllent progress in outpatient therapy then. But i had family wathcing me and my daughter cuz I was suicidal for NO reason. I was never so scared in my life. to be alone in the shower with a razor, to be alone at home without my daughter and some pills. Drs had me on zyprexa, depakote, risperdal, and many other combos till paxil worked. those other drugs made me worse and sooooo tired i couldnt care for myself or baby.
I noticed the withdrawl from paxil when i missed 2days of pills. I hate the sexual side effects! Anyway, with my 2 pregnancies, the dr said risk was taking paxil in 3rd trimenster due to withdrwal in abby, now GSK says 1st trimester causes birth defects..but not lawyer will take my case cuz it is not a heart condition?!?!?!? AND LAWYERS TOOK CASES FROM READERS OF JAMES FREY'S BOOK "A MILLION LITTLE PIECES"!?!?!?!?!?!?!?] this world is crazy, and now due to paxil, so am I. I am so torn--be hapy with the family i have..but I just want to have another child. Watching March of the Penguins last nite, I cried and cried. But then part of me wants to just forget this all--get off this crap and focus on NOW. no more kids-pregnant or foster to adotp(which we wanted to do after Vincent cuz we thought hydrocephalus might happen again-which now I truely beleiuve Paxil caised and the gentic testeing proves it wasnt us) but it could have been a fluke. The 1% chance of this horrible condition just happened to us. HEALTHY people!! (sarcasm) sorry so long, and all the typos...but i get the feeling my sisters are tired of hearing me and my husband just gets so sad when I talk about Vincent. Thanks for listening. I look forward to meeting you at the protest. My husband said he will come with me too |
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#10 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Re: Paxil and Pregnancy-Official warnings!
Paxil takes it's toll in so many ways. You've been through the mill. Take it easy and something to keep in the back of your mind is that liquid paxil would allow you to wean 1mg or even .5mg at a time. It would be a long wean, but going so slow would also minimize the withdrawal. Looking forward to meeting you in the Fall.
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#11 |
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Join Date: Feb 2006
Posts: 3
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Re: Paxil and Pregnancy-Official warnings!
Thanks for understanding
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#12 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Re: Paxil and Pregnancy-Official warnings!
Putting that anger to good use!!!!
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#13 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Re: Paxil and Pregnancy-Official warnings!
__________________
AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#14 |
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Join Date: Jul 2005
Location: Texas
Posts: 13,811
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Re: Paxil and Pregnancy-Official warnings!
I think if you have a baby while on an SSRI, it is so important to plan on breastfeeding. I truly believe that saved Kate a lot of suffering.
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Katesmom aka Kim started Paxil Oct. 2003 for PIH Paxil free since 19 Jul 2005 ". . .the cruelest lies are often told without a word. . .the kindest truths are often spoken, never heard." -- Ben Folds |
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#15 |
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"has a lavender scented keyboard"
Join Date: Mar 2004
Location: Ontario
Posts: 22,214
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Re: Paxil and Pregnancy-Official warnings!
I have to agree Kim, breastfeeding is very important in order to wean off instead of getting cut off.
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Rita |
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#16 |
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Join Date: Jan 2006
Location: oregon
Posts: 7
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Re: Paxil and Pregnancy-Official warnings!
wow. I just wanted to say thank you for sharing the information.
I have been reading posts everyday,but have not posted myself. but I just feel like sharing now. The reason why I wanted off was to get pregnant again, and my midwife said the drug coompany was looking like it was being sectretive. She was write. I am going to send her to this web site so she is EVEN better informed. When I started paxil I was still breastfeeding. I saw a major difference in my son's behavior afterwards. Now, he was not a newborn at this time, but in all the reading I've done on this site, well, da of course it affected him. I feel so stupid for letting myself take this drug. For what I did to my son and my body. I was feeling pretty low about it, but my husband is trying to reassure me that yes, at that time I did need the drug,but now I have learned how to deal. I just cannot believe the withdrawing is so hard though. AND since I am taking this slowly I have been taking the 15 now for a couple of weeks, I've seen that I really didn't need to be on 20mg. I could have been on 15mg. Another reason why i'm feeling stupid. So. I just want to thank everyone for sharing such personal accounts of their lives. It is hard for people to understand what we are going through. |
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#17 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Re: Paxil and Pregnancy-Official warnings!
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#18 |
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Administrator
Join Date: Feb 2004
Location: new jersey
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Re: Paxil and Pregnancy-Official warnings!
http://bodyandhealth.canada.com/chan...l_id=41&rot=11
Antidepressants while pregnant may cause pre-term, underweight babies: study Provided by: Canadian Press Written by: SHERYL UBELACKER Apr. 6, 2006 TORONTO (CP) - Taking certain antidepressants during pregnancy may increase the risk of premature delivery, underweight babies, stillbirths and seizures in newborns, a Canadian study suggests. The study led by researchers at the Ottawa Health Research Institute found pregnant women who took Prozac, Paxil, Zoloft and other selective serotonin re-uptake inhibitors, or SSRIs, had a higher incidence of adverse birth outcomes compared with women who weren't taking the popular drugs while pregnant. But Dr. Mark Walker, a high-risk obstetrician and senior author of the study, stressed that the researchers found only a correlation, not proof that the antidepressants caused the abnormalities. Furthermore, some obstetrical experts say it may be the depression itself - and not the drugs - that leads to the problems, and going off the drugs during pregnancy could be dangerous for both a woman and her baby. Using 1990-2000 health records from Saskatchewan, Walker's team compared 972 pregnant women taking SSRIs and a control group of almost 3,900 women who were not on the medications during pregnancy. Women in the two groups were matched for age, the type of hospital where they gave birth, socioeconomic status based on postal code area and other factors. "I was surprised at the degree of effect we found," Walker said from Ottawa. "We found there was almost a doubling in the increase" of low birth-weight infants - nine per cent in the SSRI group versus five per cent in the control group. "Women on SSRIs were more likely to have a pre-term birth - almost 20 per cent versus 12 per cent in our control group," he said. "Fetal death - that's stillbirth - was more common, about two times more common," at one per cent in the drug group versus 0.4 per cent among controls. Seizures - thought to be one symptom of a newborn's withdrawal from SSRI exposure - during the 48 hours after birth were almost four times more common in the offspring of women who had taken the drugs, Walker said. "What we cannot determine is (whether) it's the fact that these women are depressed and perhaps have other medical problems or is it the SSRIs," he said, noting that the study tried to adjust for such factors as low socioeconomic status and drug abuse by some women. "But what we do know is that this group of women are at higher risk for these outcomes and they do need to be followed more carefully and have increased surveillance in their pregnancies. "Every patient should talk to their doctor about their medication and the safety of staying on them," said Walker, whose study is published in the April issue of the American Journal of Obstetrics and Gynecology. Dr. Gideon Koren, head of the Motherisk Program at Toronto's Hospital for Sick Children, is critical of the researchers' interpretation, saying that scores of studies show that women with depression during pregnancy have higher risks for underweight newborns, premature delivery and other problems - whether they are taking SSRIs, other antidepressants or none at all. "Women with depression, because of the depression, are not proactive about their health, they are not going to (doctors') appointments, they are not eating well, they don't have an appetite, they tend to smoke more," Koren, a pediatrician and pharmacologist, said Wednesday. "And then at the end there is now more and more compelling research that the stress associated with psychiatric morbidity has detrimental effects on the fetus." Dr. Shaila Misri, a professor of psychiatry, obstetrics and gynecology at the University of British Columbia, agreed, saying that women who are seriously depressed but not treated show altered chemistry in their bodies - "in which the baby is growing for the next 40 weeks." "And those who don't go on treatment, we are concerned about how lack of treatment and change in their biochemistry will affect them and the babies," Misri, author of the book Pregnancy Blues, said from Vancouver. Referring to one patient who has been on Paxil throughout her pregnancy, Misri asked: "Do you think she wants to be? Do you think I want to put her on it? No. But she didn't have a choice because her illness and her symptoms outweigh the risks of her taking it." Koren worries that data from the study could be misinterpreted by pregnant women suffering from depression, who could stop their medication for fear they are trading their babies' health for their own mental well-being. "The danger is tremendous . . . untreated depression in late pregnancy is the best predictor of postpartum depression, with its huge risk for the life of the woman and for the baby." (Untreated depression could lead to psychosis and/or suicide in some women.) Dr. Christina Chambers, a specialist in pediatrics and preventive medicine at the University of California at San Diego, said the study's findings of neonatal complications are similar to those from several other SSRI studies. Research she published in February suggests a possible link between moms-to-be taking the drugs and a serious lung problem in infants. Another study found an increased risk of heart defects related to Paxil. Chambers said scientists are still trying to tease out the actual cause-effect relationship to SSRIs. Confounding issues include, for instance, the fact that depressed women tend to smoke - and tobacco use can cause pre-term and underweight infants. "It's easy for someone to hear negative information about a drug in pregnancy and think, 'Oh my gosh, I've got to quit it right away,' and that can be not a good thing to do," she said. "Our position has always been that it's better for people to know what they're up against and if there is a risk associated with it, how big is the risk and is it something that's manageable? "Obviously, women shouldn't be making the decision independently that they're going to go off the drug without discussing it with their health provider." __________________
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#19 |
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Administrator
Join Date: Feb 2004
Location: new jersey
Posts: 46,992
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Re: Paxil and Pregnancy-Official warnings!
http://www.news-medical.net/?id=17514
Bolding is mine. This study does not limit the risks to Paxil alone. Popular antidepressants may affect fetus Medical Studies/Trials Published: Thursday, 20-Apr-2006 A team from the Ottawa Health Research Institute, the University of Ottawa, and The Ottawa Hospital has found an increased risk of premature delivery, low birth weight, fetal death, and infant seizures among pregnant women who used a popular class of antidepressants during pregnancy. The study, published in the April issue of the American Journal of Obstetrics and Gynecology, uses linked maternal / infant prescription and health records to assess the safety of a class of antidepressants known as selective serotonin re-uptake inhibitors (SSRIs). Records were obtained for 972 pregnant women taking SSRIs and 3,878 matched controls not taking SSRIs. The investigators found that the SSRI group had a significantly increased risk of premature birth (19.3 per cent versus 12.0 per cent), low birth weight (9.0 per cent versus 5.3 per cent), fetal death (1.1 per cent versus 0.4 per cent) and infant seizures (0.4 per cent versus 0.1 per cent). There was no increased risk of birth defects, infection, need for respiratory support, or death up to one year after birth. While previous studies have reported side effects of SSRIs on the developing fetus, this investigation is the largest ever to examine such a wide variety of effects without relying on patient memory for prescription records. "These results are certainly unsettling," said Dr. Mark Walker, a Scientist at the Ottawa Health Research Institute and one of the study's lead authors. "But untreated depression has also been shown to have side effects on women, and possibly on their fetuses. I feel that it is important that every case be individually assessed to determine the risks and benefits of antidepressant therapy. Patients need to make informed decisions and for those women on SSRIs, we should increase our surveillance." Dr. Walker is also a physician in the Department of Obstetrics and Gynecology at The Ottawa Hospital and an Associate Professor in the Faculty of Medicine at the University of Ottawa. The study included SSRIs such as fluoxetine (Prozac) Paroxetine (Paxil) and Sertraline (Zoloft), but the sample size was not large enough to estimate risks for each SSRI individually. "SSRIs have improved health and quality of life for a huge number of people, but in light of this study, we must be ever more careful to weigh the potential benefits of treatment with the potential risks," said Dr. Robert Swenson, Associate Chief of Psychiatry at the Ottawa Hospital, Associate Professor of Psychiatry at the University of Ottawa, and a Clinical Investigator at the Ottawa Health Research Institute. "Above all, it is important that anyone taking SSRIs seek professional advice before changing or stopping treatment." SSRIs are generally considered the first-line drug therapy in most patients with depression, and approximately 10 per cent of pregnant women suffer from clinical depression. The research team also includes Dr. Shi Wu Wen, Dr. Qiuying Yang, Dr. Peter Garner and Dr. Carl Nimrod, all from the Ottawa Health Research Institute (an Affiliated Research Institute of the University of Ottawa and the research arm of The Ottawa Hospital). Dr. William Fraser of the University of Montreal and Dr. Olufemi Olatunbosun of the University of Saskatchewan are also co-authors. Data was obtained from Saskatchewan Health Database records collected between January 1, 1990 and December 31, 2000. The unique database is an invaluable tool for researchers because it tracks prescription drug use over patient lifetimes. The study was funded by a grant received from The Hospital for Sick Kids Foundation. Both Dr. Shi Wu Wen and Dr. Mark Walker are supported by New Investigator Awards from the Canadian Institutes of Health Research (CIHR). __________________
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#20 |
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"has a lavender scented keyboard"
Join Date: Mar 2004
Location: Ontario
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Re: Paxil and Pregnancy-Official warnings!
Things are moving along now... they cannot keep burying these facts!!
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Rita |
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#21 |
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Administrator
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Re: Paxil and Pregnancy-Official warnings!
We knew that the additional drugs being listed were only a matter of time. An ssri is an ssri!
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#22 |
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"has a lavender scented keyboard"
Join Date: Mar 2004
Location: Ontario
Posts: 22,214
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Re: Paxil and Pregnancy-Official warnings!
Yes, this is really amazing to see it in print though!!
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Rita |
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#23 |
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Administrator
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Re: Paxil and Pregnancy-Official warnings!
Rita, did you see this
The study was funded by a grant received from The Hospital for Sick Kids Foundation You're favorite place.
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AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK |
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#24 |
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"has a lavender scented keyboard"
Join Date: Mar 2004
Location: Ontario
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Re: Paxil and Pregnancy-Official warnings!
I noticed that right off and was really quite amazed since they are so quick to drug the kids!
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Rita |
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#25 |
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Join Date: Apr 2006
Location: St. Augustine, Florida
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Re: Paxil and Pregnancy-Official warnings!
Hi! I recently found out that I was pregnant
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