New Warning Issued on Paxil

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New Warning Issued on Paxil

http://articles.health.msn.com/id/100110565

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FDA says company study found higher number of birth

defects if used in first trimester

By Gardner, HealthDay Reporter

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WEDNESDAY, Sept. 28 (HealthDay News) -- U.S. health

officials have issued a warning about possible birth

defects in infants born to women who take the

antidepressant Paxil during the first trimester of

pregnancy.

A study sponsored by GlaxoKline, the drug's

maker, suggested that infants born to women taking

Paxil were at about double the risk of birth defects

compared with women taking other antidepressants. The

most common defects were cardiovascular. The risks

were about 50 percent higher than they were in the

general population.

GlaxoKline, which first alerted the U.S. Food and

Drug Administration of the problems around Sept. 6,

anticipates labeling changes to the drug, said company

spokeswoman Ann Rhyne.

" We've also taken this information to regulatory

bodies around the world to voluntarily add this to the

label, " she said. " That discussion, as I understand

it, is how to handle it. "

Glaxo has also sent a letter to physicians alerting

them to the findings.

Dr. Jo O'Sullivan, a professor of obstetrics and

gynecology at the University of Miami School of

Medicine, said the findings do raise some concerns.

" One cannot deny with absolute certainty that there's

nothing related to Paxil and an increased risk of

malformations, but we dont have a truly controlled

population, " she said.

" One has to be cautious and if there's a way to get a

patient off Paxil prior to pregnancy and substitute

another drug, then that would be the ideal way to go, "

O'Sullivan advised. " But just because she's on Paxil

does not necessarily mean that her risk of congenital

malformation is overwhelming. This needs more work. "

Paxil (paroxetine) belongs to a group of drugs called

selective serotonin reuptake inhibitors (SSRIs), which

first hit the market in 1988 and are widely used today

to treat depression, anxiety and other mood and

behavioral disorders in adults as well as children.

This class of popular drugs has been the subject of

much recent controversy.

In February, Spanish researchers reported that babies

born to women taking SSRIs during pregnancy may

experience neonatal withdrawal syndrome in the first

few days of life. The association seemed to be highest

among women using Paxil.

And last year, reports of suicidal thinking among

adolescents using SSRIs led to the FDA ordering a

" black box " warning be placed on SSRI labels. There

has also been concern that SSRIs triggers manic

behavior in 10- to 14-year-olds.

The data on SSRIs and birth defects is inconclusive,

with some studies showing a higher risk and other

research showing no increased problem.

GlaxoKline undertook this study because a British

pregnancy registry turned up a possible signal for

cardiovascular defects in women using bupropion

(Wellbutrin) and Paxil.

For this study, the researchers relied on a database

affiliated with UnitedHealthcare, a national

managed-care plan covering the Northeast, Southeast,

Midwest and Western United States. They focused on

women taking bupropion in the first trimester of

pregnancy and compared them with infants born to women

who took bupropion before or after the first

trimester, as well as women taking other

antidepressants during the first trimester.

When all analyses were completed, there appeared to be

no increased risk associated with bupropion. A

secondary analysis to investigate the risk associated

with other antidepressants, including Paxil, was

carried out at the request of the FDA.

That analysis found about double the risk of general

birth defects in Paxil compared to other

antidepressants, when taken in the first trimester.

The prevalence of birth defects as a whole among

infants born to women in this group was 4 percent, or

43.6 per 1,000 births.

The risk for cardiovascular defects was slightly more

than double. The more common of these were ventricular

septal defects, where one or more holes are present in

the muscular wall separating the right and left

ventricles of the heart. This is the most common

congenital heart defect.

The overall rate of birth defects in the general

population is about 3 percent, and the rate of heart

defects about 1 percent. The overall rate among

infants of women taking Paxil in the first trimester

was about 4 percent and, for women taking other

antidepressants during this time, about 2 percent. " I

wished I had an explanation, " Rhyne said of the

discrepancy.

Researchers still do not know if the relationship is a

causal one and there is, in general, a paucity of

research on the subject. Data from the Swedish Birth

Registry, for instance, found no increased risk of

major malformations associated with SSRIs. But other

small studies have found risks.

" There's not a whole lot of detail there, " Rhyne said.

" We're trying to drill down on information that we

have to see exactly what is going on. "

And for women who are on Paxil or considering taking

it, GlaxoKline said it is sticking by previous

recommendations.

" This medicine already has a pregnancy precaution.

That means that physicians should be talking with

patients about potential benefits and potential risks

and we recommend that this study be a part of that

discussion, " Rhyne said. " The label already has a

category C pregnancy caution, which means no adequate,

well-controlled studies have been done to determine

the effect on the fetus. This is a medicine doctors

should already be talking with patients about. "

" Like everything else, it's a risk-and-benefit ratio, "

O'Sullivan said.

More information

The U.S. Food and Drug Administration has more on the

recent information regarding Paxil.