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Paroxetine (Paxil or Paxil CR) can more than triple major cardiac

birth defects

http://www.healthsentinel.com/org_news.php?id=115 & title=Paroxetine+

(Paxil+or+Paxil+CR)

+can+more+than+triple+major+cardiac+birth+defects & event=org_news_print

_list_item

Roman Bystrianyk, " Paroxetine (Paxil or Paxil CR) can more than

triple major cardiac birth defects " , Health Sentinel, December 29,

2006,

Paroxetine, known by the brand names Paxil or Paxil CR in the United

States, is a selective serotonin reuptake inhibitor, or SSRI,

antidepressant. Paroxetine was introduced in 1992 by GlaxoKline

and has become one of the most prescribed antidepressants on the

market. In fact, paroxetine is the third most prescribed

antidepressant in the United States and the most prescribed

antidepressant in Canada.

In late 2005 the FDA and Health Canada issued two warnings regarding

first trimester exposure to paroxetine and the increased risk of

cardiac malformation in newborns. A study in Reproductive Toxicology

published in April 2006 showed a two-fold increased risk of cardiac

malformations in women taken paroxetine during the first trimester.

This conclusion agreed with earlier unpublished reports performed in

2005 by GlaxoKline also showing a doubled risk of cardiac

malformations.

A new study published in Birth Defects Research Part B: Developmental

and Reproductive Toxicology, examined in greater detail the

association between exclusive first trimester exposure to paroxetine

and the occurrence of any major congenital malformation, and more

specifically, major cardiac malformations. The authors used a number

of medical databases examining all pregnancies that occurred in

Quebec between January 1997 and July 2003.

Adjusting for a number of variables, as well as for second and third

trimester exposure to antidepressants, paroxetine exposure during the

first trimester or pregnancy compared with the use of other SSRI and

non-SSRI antidepressants did not significantly raise the risk of

congenital malformations. Although this showed no difference in birth

defects it must be taken with the information found in a recent

population-based cohort study that found the use of any SSRI

antidepressant in the first trimester of pregnancy resulted in a 40%

increase in birth defects and more specifically a 60% increased risk

in cardiac abnormalities.

When the study authors examined a dose of paroxetine of greater than

25 mg (milligrams) they found a major increase in general birth and

specifically cardiac defects. " Paroxetine was significantly

associated with a two-fold increase in the risk of major congenital

anomalies, and more specifically with a three-fold increase in the

risk of major cardiac anomalies. "

Again, this study compared paroxetine with other antidepressant drugs

so the 200% increase in major congenital birth defects and 300%

increase in cardiac malformations could reasonably be 240% and 360%

if compared to those not taking any antidepressant medication.

The authors conclude, " using a population based pregnancy registry,

our study showed no increased risk of major congenital malformations,

specifically major cardiac malformations, associated with the first

trimester exposure to paroxetine. For the first time, however, a dose-

response relationship between average daily dose of paroxetine

utilization during the first trimester of pregnancy and occurrence of

major congenital malformations, and major cardiac malformations, was

found. Pregnant users of more than 25 mg/day of paroxetine were at a

two-fold increased risk of having an infant with a major

malformation, and at a three-fold increased risk of having an infant

with a major cardiac malformation. "

SOURCE: Birth Defects Research Part B: Developmental and Reproductive

Toxicology, December 2006

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Paroxetine (Paxil or Paxil CR) can more than triple major cardiac

birth defects

http://www.healthsentinel.com/org_news.php?id=115 & title=Paroxetine+

(Paxil+or+Paxil+CR)

+can+more+than+triple+major+cardiac+birth+defects & event=org_news_print

_list_item

Roman Bystrianyk, " Paroxetine (Paxil or Paxil CR) can more than

triple major cardiac birth defects " , Health Sentinel, December 29,

2006,

Paroxetine, known by the brand names Paxil or Paxil CR in the United

States, is a selective serotonin reuptake inhibitor, or SSRI,

antidepressant. Paroxetine was introduced in 1992 by GlaxoKline

and has become one of the most prescribed antidepressants on the

market. In fact, paroxetine is the third most prescribed

antidepressant in the United States and the most prescribed

antidepressant in Canada.

In late 2005 the FDA and Health Canada issued two warnings regarding

first trimester exposure to paroxetine and the increased risk of

cardiac malformation in newborns. A study in Reproductive Toxicology

published in April 2006 showed a two-fold increased risk of cardiac

malformations in women taken paroxetine during the first trimester.

This conclusion agreed with earlier unpublished reports performed in

2005 by GlaxoKline also showing a doubled risk of cardiac

malformations.

A new study published in Birth Defects Research Part B: Developmental

and Reproductive Toxicology, examined in greater detail the

association between exclusive first trimester exposure to paroxetine

and the occurrence of any major congenital malformation, and more

specifically, major cardiac malformations. The authors used a number

of medical databases examining all pregnancies that occurred in

Quebec between January 1997 and July 2003.

Adjusting for a number of variables, as well as for second and third

trimester exposure to antidepressants, paroxetine exposure during the

first trimester or pregnancy compared with the use of other SSRI and

non-SSRI antidepressants did not significantly raise the risk of

congenital malformations. Although this showed no difference in birth

defects it must be taken with the information found in a recent

population-based cohort study that found the use of any SSRI

antidepressant in the first trimester of pregnancy resulted in a 40%

increase in birth defects and more specifically a 60% increased risk

in cardiac abnormalities.

When the study authors examined a dose of paroxetine of greater than

25 mg (milligrams) they found a major increase in general birth and

specifically cardiac defects. " Paroxetine was significantly

associated with a two-fold increase in the risk of major congenital

anomalies, and more specifically with a three-fold increase in the

risk of major cardiac anomalies. "

Again, this study compared paroxetine with other antidepressant drugs

so the 200% increase in major congenital birth defects and 300%

increase in cardiac malformations could reasonably be 240% and 360%

if compared to those not taking any antidepressant medication.

The authors conclude, " using a population based pregnancy registry,

our study showed no increased risk of major congenital malformations,

specifically major cardiac malformations, associated with the first

trimester exposure to paroxetine. For the first time, however, a dose-

response relationship between average daily dose of paroxetine

utilization during the first trimester of pregnancy and occurrence of

major congenital malformations, and major cardiac malformations, was

found. Pregnant users of more than 25 mg/day of paroxetine were at a

two-fold increased risk of having an infant with a major

malformation, and at a three-fold increased risk of having an infant

with a major cardiac malformation. "

SOURCE: Birth Defects Research Part B: Developmental and Reproductive

Toxicology, December 2006

Link to comment
Share on other sites

Paroxetine (Paxil or Paxil CR) can more than triple major cardiac

birth defects

http://www.healthsentinel.com/org_news.php?id=115 & title=Paroxetine+

(Paxil+or+Paxil+CR)

+can+more+than+triple+major+cardiac+birth+defects & event=org_news_print

_list_item

Roman Bystrianyk, " Paroxetine (Paxil or Paxil CR) can more than

triple major cardiac birth defects " , Health Sentinel, December 29,

2006,

Paroxetine, known by the brand names Paxil or Paxil CR in the United

States, is a selective serotonin reuptake inhibitor, or SSRI,

antidepressant. Paroxetine was introduced in 1992 by GlaxoKline

and has become one of the most prescribed antidepressants on the

market. In fact, paroxetine is the third most prescribed

antidepressant in the United States and the most prescribed

antidepressant in Canada.

In late 2005 the FDA and Health Canada issued two warnings regarding

first trimester exposure to paroxetine and the increased risk of

cardiac malformation in newborns. A study in Reproductive Toxicology

published in April 2006 showed a two-fold increased risk of cardiac

malformations in women taken paroxetine during the first trimester.

This conclusion agreed with earlier unpublished reports performed in

2005 by GlaxoKline also showing a doubled risk of cardiac

malformations.

A new study published in Birth Defects Research Part B: Developmental

and Reproductive Toxicology, examined in greater detail the

association between exclusive first trimester exposure to paroxetine

and the occurrence of any major congenital malformation, and more

specifically, major cardiac malformations. The authors used a number

of medical databases examining all pregnancies that occurred in

Quebec between January 1997 and July 2003.

Adjusting for a number of variables, as well as for second and third

trimester exposure to antidepressants, paroxetine exposure during the

first trimester or pregnancy compared with the use of other SSRI and

non-SSRI antidepressants did not significantly raise the risk of

congenital malformations. Although this showed no difference in birth

defects it must be taken with the information found in a recent

population-based cohort study that found the use of any SSRI

antidepressant in the first trimester of pregnancy resulted in a 40%

increase in birth defects and more specifically a 60% increased risk

in cardiac abnormalities.

When the study authors examined a dose of paroxetine of greater than

25 mg (milligrams) they found a major increase in general birth and

specifically cardiac defects. " Paroxetine was significantly

associated with a two-fold increase in the risk of major congenital

anomalies, and more specifically with a three-fold increase in the

risk of major cardiac anomalies. "

Again, this study compared paroxetine with other antidepressant drugs

so the 200% increase in major congenital birth defects and 300%

increase in cardiac malformations could reasonably be 240% and 360%

if compared to those not taking any antidepressant medication.

The authors conclude, " using a population based pregnancy registry,

our study showed no increased risk of major congenital malformations,

specifically major cardiac malformations, associated with the first

trimester exposure to paroxetine. For the first time, however, a dose-

response relationship between average daily dose of paroxetine

utilization during the first trimester of pregnancy and occurrence of

major congenital malformations, and major cardiac malformations, was

found. Pregnant users of more than 25 mg/day of paroxetine were at a

two-fold increased risk of having an infant with a major

malformation, and at a three-fold increased risk of having an infant

with a major cardiac malformation. "

SOURCE: Birth Defects Research Part B: Developmental and Reproductive

Toxicology, December 2006

Link to comment
Share on other sites

Paroxetine (Paxil or Paxil CR) can more than triple major cardiac

birth defects

http://www.healthsentinel.com/org_news.php?id=115 & title=Paroxetine+

(Paxil+or+Paxil+CR)

+can+more+than+triple+major+cardiac+birth+defects & event=org_news_print

_list_item

Roman Bystrianyk, " Paroxetine (Paxil or Paxil CR) can more than

triple major cardiac birth defects " , Health Sentinel, December 29,

2006,

Paroxetine, known by the brand names Paxil or Paxil CR in the United

States, is a selective serotonin reuptake inhibitor, or SSRI,

antidepressant. Paroxetine was introduced in 1992 by GlaxoKline

and has become one of the most prescribed antidepressants on the

market. In fact, paroxetine is the third most prescribed

antidepressant in the United States and the most prescribed

antidepressant in Canada.

In late 2005 the FDA and Health Canada issued two warnings regarding

first trimester exposure to paroxetine and the increased risk of

cardiac malformation in newborns. A study in Reproductive Toxicology

published in April 2006 showed a two-fold increased risk of cardiac

malformations in women taken paroxetine during the first trimester.

This conclusion agreed with earlier unpublished reports performed in

2005 by GlaxoKline also showing a doubled risk of cardiac

malformations.

A new study published in Birth Defects Research Part B: Developmental

and Reproductive Toxicology, examined in greater detail the

association between exclusive first trimester exposure to paroxetine

and the occurrence of any major congenital malformation, and more

specifically, major cardiac malformations. The authors used a number

of medical databases examining all pregnancies that occurred in

Quebec between January 1997 and July 2003.

Adjusting for a number of variables, as well as for second and third

trimester exposure to antidepressants, paroxetine exposure during the

first trimester or pregnancy compared with the use of other SSRI and

non-SSRI antidepressants did not significantly raise the risk of

congenital malformations. Although this showed no difference in birth

defects it must be taken with the information found in a recent

population-based cohort study that found the use of any SSRI

antidepressant in the first trimester of pregnancy resulted in a 40%

increase in birth defects and more specifically a 60% increased risk

in cardiac abnormalities.

When the study authors examined a dose of paroxetine of greater than

25 mg (milligrams) they found a major increase in general birth and

specifically cardiac defects. " Paroxetine was significantly

associated with a two-fold increase in the risk of major congenital

anomalies, and more specifically with a three-fold increase in the

risk of major cardiac anomalies. "

Again, this study compared paroxetine with other antidepressant drugs

so the 200% increase in major congenital birth defects and 300%

increase in cardiac malformations could reasonably be 240% and 360%

if compared to those not taking any antidepressant medication.

The authors conclude, " using a population based pregnancy registry,

our study showed no increased risk of major congenital malformations,

specifically major cardiac malformations, associated with the first

trimester exposure to paroxetine. For the first time, however, a dose-

response relationship between average daily dose of paroxetine

utilization during the first trimester of pregnancy and occurrence of

major congenital malformations, and major cardiac malformations, was

found. Pregnant users of more than 25 mg/day of paroxetine were at a

two-fold increased risk of having an infant with a major

malformation, and at a three-fold increased risk of having an infant

with a major cardiac malformation. "

SOURCE: Birth Defects Research Part B: Developmental and Reproductive

Toxicology, December 2006

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