Pregnant Women Warned By FDA to Avoid Paxil

The Washington Post ^ | December 9, 2005 | Marc Kaufman and Shankar Vedantam

[neverdem]

The Food and Drug Administration warned pregnant women and their doctors away from the antidepressant Paxil yesterday because of an increased risk of heart defects in newborns.

With the warning, the agency for the first time placed a popular antidepressant -- one in the same drug class as Prozac and Zoloft -- into its second-highest category for risk of birth defects. The agency did not say Paxil could never be used by pregnant women, but it did say the FDA "is advising patients that this drug should usually not be taken during pregnancy."

The advisory is based on early results from two studies, which found that women who took Paxil in the first three months of pregnancy were 1 1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall. The studies found that Paxil had a risk of birth defects that other common antidepressants did not.

"If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug," said Robert Temple, the FDA's director of medical policy. "Abrupt withdrawal of Paxil has its own problems, but the clear suggestion here is that you might want to think about a change."

In the studies cited by the FDA, the risk of heart defects is about 1 percent overall and rose to 1.5 to 2 percent in infants born to women taking Paxil.

Although researchers have been concerned for some time about the effect of selective serotonin reuptake inhibitors (SSRIs) on fetuses, yesterday's announcement by the FDA and Paxil manufacturer GlaxoSmithKline is the strongest indication so far that there may be significant risks. Since a large number of pregnant women suffer some form of depression -- some...

[neverdem]

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FOR IMMEDIATE RELEASE P05-97 December 8, 2005

Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Advising of Risk of Birth Defects with Paxil
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/advisory/paroxetine200512.htm and
CDER Information Sheets: http://www.fda.gov/cder/drug/infopage/paroxetine/default.htm.

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[43north]

EVERYONE should avoid Paxil. It is a garbage drug that will:

1. Make you sleepy ALL the time.

2. Murder your sex drive.

3. Make you gain a LOT of weight.

4. Give you absolute fits when you try to quit it.

Of course, it DOES make your depression better because you become a zombie who cares about NOTHING. The FDA should yank this crap off the market ASAP.

I am a primary care provider and I know of what I speak. I do not prescribe this drug - EVER!

[VeritatisSplendor]

Paxil worked very well for me. Cured my depression and panic attacks, and made me more outgoing. At the standard minimum dose 20 mg. I felt inappropriately mellow so I went down to 10 mg. Excellent results. Five pounds weight gain, sex drive restored - what do you think depression does to that? No problem quitting, either. My baby was born with a healthy heart.

Now in the interests of honesty - it did raise my blood pressure. But since the two other SSRIs I tried had negative effects, and my psychiatrist believed that that indicated I would respond negatively to other SSRIs - if I was faced with severe and lasting depression, I would go back to the Paxil. (I would do exercise, light therapy, prayer and accupuncture first - and if that still didn't work... the Paxil.)

So don't knock it for everyone. It can be very beneficial for some - and I am sure others could have the results you saw.

Mrs VS

[FeeinTennessee]

We are the most "drugged" up nation on the planet. Why would anyone want to use an anti-depressant when they are pregneant anyway? During pregnancy, don't women display a certain happiness when carrying a life?

[traviskicks]

Why would anyone want to use an anti-depressant when they are pregneant anyway?
---

Try to imagine the saddest most lonely time in your entire life and multipy it by 100. That is depression. I've never experienced it, but recognize that some people need help, or at least a 'breather' to let them get back on their feet. Often, drugs are literally lifesavers.

[beaver fever]

1. Make you sleepy ALL the time.

2. Murder your sex drive.

3. Make you gain a LOT of weight.

4. Give you absolute fits when you try to quit it.

I tried it for three months.

It does reduce anxiety but I gained thirty pounds without changing my diet. I was less stressed but I was a complete vegetable. No desire to do anything. But I was happy,

I quit when I experienced weird auditory hallucinations.

I quit cold turkey without psychotic episodes but that was due to the fact that I was only on it for three months.

I have read accounts of suicidal withdrawal after only six months.

PAXIL is evil and should be avoided at all costs.

[heartwood]

As for the use of Paxil during pregnancy - I had a severe breakdown after two miscarriages. Nothing helped, not prayer or counseling. The Paxil gave me back myself. As soon as I found out I was pregnant again, I stopped the Paxil - but it was not a happy time because I was afraid I would lose that baby too. Then came the 9/11 attacks - close to home - a neighbor of ours died and eight men from our church - and we had anthrax at our post office. I couldn't eat - I lost weight. My obstetrician told me to go back on the Paxil. I thank God I had a healthy baby.

There are many reasons why pregnancy might not be a happy time.

Mrs VS