Antidepressants to Come with Pregnancy Precaution

[Guest guest]

http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040609\

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Antidepressants to Come with Pregnancy Precaution

Wed Jun 9, 5:42 PM ET

By Richwine

ROCKVILLE, Md. (Reuters) - Drug makers are adding a notice to widely used

antidepressants that babies of women who take the drugs late in pregnancy

may experience jitteriness and other withdrawal symptoms, U.S. officials

said on Wednesday.

The Food and Drug Administration (news - web sites) urged the precaution in

light of scores of reports of withdrawal effects in newborns of women who

took certain antidepressants during the third trimester of pregnancy, agency

officials said.

The new information on drug labels urges physicians to carefully weigh

benefits and risks of antidepressant therapy in women during the late stages

of pregnancy, said Dr. Levin, a medical reviewer in the FDA's

division of neuropharmacological drug products.

Untreated depression poses serious risks for mother and baby, too, so

doctors should not automatically avoid giving the drugs during pregnancy,

FDA officials and members of an outside advisory panel emphasized.

One option is to consider tapering off depression drugs 10 to 14 days before

a mother's due date, Levin said.

Babies' withdrawal symptoms were reported after their mothers used drugs

such as Prozac and Zoloft that are known as selective serotonin reuptake

inhibitors, or SSRIs, as well as another antidepressant called Effexor made

by Wyeth .

Some of the most frequent withdrawal symptoms in infants included

jitteriness, tremors, breathing difficulties, and trouble sleeping. Effects

usually resolved on their own within days but in some cases required

extended hospital stays, insertion of feeding tubes or other treatment.

Long-term consequences are unknown, FDA officials and outside physicians

said.

" Clinicians need to be aware of the potential for these events, " Levin told

an FDA advisory committee.

An estimated 10 percent to 16 percent of pregnant women suffer from

depression, Levin said. Without treatment, serious depression can lead to

suicides, social isolation and malnutrition, a potential problem for

developing fetuses.

GlaxoKline Plc, Wyeth and Forest Laboratories already have added a

precaution about risks to babies to the labels of their depression drugs,

Levin said. Glaxo sells Paxil and Forest sells Celexa and Lexapro. Generic

makers of fluvoxamine, another SSRI, also have added the information, Levin

said.

Eli Lilly has verbally committed to adding the information to Prozac's

label, and the FDA still is talking with Pfizer Inc. about Zoloft, Levin

said. Pfizer " supports the need to provide physicians with accurate

information " regarding antidepressant use during pregnancy, company

spokeswoman Shreya Prudlo said.

SSRIs boost the brain's use of the chemical serotonin. Effexor maximizes

levels of both serotonin and another brain chemical called norepinephrine.

(Additional reporting by Heavey in Washington)

[Guest guest]

http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040609\

/hl_nm/health_antidepressants_dc

Antidepressants to Come with Pregnancy Precaution

Wed Jun 9, 5:42 PM ET

By Richwine

ROCKVILLE, Md. (Reuters) - Drug makers are adding a notice to widely used

antidepressants that babies of women who take the drugs late in pregnancy

may experience jitteriness and other withdrawal symptoms, U.S. officials

said on Wednesday.

The Food and Drug Administration (news - web sites) urged the precaution in

light of scores of reports of withdrawal effects in newborns of women who

took certain antidepressants during the third trimester of pregnancy, agency

officials said.

The new information on drug labels urges physicians to carefully weigh

benefits and risks of antidepressant therapy in women during the late stages

of pregnancy, said Dr. Levin, a medical reviewer in the FDA's

division of neuropharmacological drug products.

Untreated depression poses serious risks for mother and baby, too, so

doctors should not automatically avoid giving the drugs during pregnancy,

FDA officials and members of an outside advisory panel emphasized.

One option is to consider tapering off depression drugs 10 to 14 days before

a mother's due date, Levin said.

Babies' withdrawal symptoms were reported after their mothers used drugs

such as Prozac and Zoloft that are known as selective serotonin reuptake

inhibitors, or SSRIs, as well as another antidepressant called Effexor made

by Wyeth .

Some of the most frequent withdrawal symptoms in infants included

jitteriness, tremors, breathing difficulties, and trouble sleeping. Effects

usually resolved on their own within days but in some cases required

extended hospital stays, insertion of feeding tubes or other treatment.

Long-term consequences are unknown, FDA officials and outside physicians

said.

" Clinicians need to be aware of the potential for these events, " Levin told

an FDA advisory committee.

An estimated 10 percent to 16 percent of pregnant women suffer from

depression, Levin said. Without treatment, serious depression can lead to

suicides, social isolation and malnutrition, a potential problem for

developing fetuses.

GlaxoKline Plc, Wyeth and Forest Laboratories already have added a

precaution about risks to babies to the labels of their depression drugs,

Levin said. Glaxo sells Paxil and Forest sells Celexa and Lexapro. Generic

makers of fluvoxamine, another SSRI, also have added the information, Levin

said.

Eli Lilly has verbally committed to adding the information to Prozac's

label, and the FDA still is talking with Pfizer Inc. about Zoloft, Levin

said. Pfizer " supports the need to provide physicians with accurate

information " regarding antidepressant use during pregnancy, company

spokeswoman Shreya Prudlo said.

SSRIs boost the brain's use of the chemical serotonin. Effexor maximizes

levels of both serotonin and another brain chemical called norepinephrine.

(Additional reporting by Heavey in Washington)

[Guest guest]

Think of the unborn going through SSRI withdrawals......

Antidepressants to Come with Pregnancy Precaution

http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040609\

/hl_nm/health_antidepressants_dc

Antidepressants to Come with Pregnancy Precaution

Wed Jun 9, 5:42 PM ET

By Richwine

ROCKVILLE, Md. (Reuters) - Drug makers are adding a notice to widely used

antidepressants that babies of women who take the drugs late in pregnancy

may experience jitteriness and other withdrawal symptoms, U.S. officials

said on Wednesday.

The Food and Drug Administration (news - web sites) urged the precaution in

light of scores of reports of withdrawal effects in newborns of women who

took certain antidepressants during the third trimester of pregnancy, agency

officials said.

The new information on drug labels urges physicians to carefully weigh

benefits and risks of antidepressant therapy in women during the late stages

of pregnancy, said Dr. Levin, a medical reviewer in the FDA's

division of neuropharmacological drug products.

Untreated depression poses serious risks for mother and baby, too, so

doctors should not automatically avoid giving the drugs during pregnancy,

FDA officials and members of an outside advisory panel emphasized.

One option is to consider tapering off depression drugs 10 to 14 days before

a mother's due date, Levin said.

Babies' withdrawal symptoms were reported after their mothers used drugs

such as Prozac and Zoloft that are known as selective serotonin reuptake

inhibitors, or SSRIs, as well as another antidepressant called Effexor made

by Wyeth .

Some of the most frequent withdrawal symptoms in infants included

jitteriness, tremors, breathing difficulties, and trouble sleeping. Effects

usually resolved on their own within days but in some cases required

extended hospital stays, insertion of feeding tubes or other treatment.

Long-term consequences are unknown, FDA officials and outside physicians

said.

" Clinicians need to be aware of the potential for these events, " Levin told

an FDA advisory committee.

An estimated 10 percent to 16 percent of pregnant women suffer from

depression, Levin said. Without treatment, serious depression can lead to

suicides, social isolation and malnutrition, a potential problem for

developing fetuses.

GlaxoKline Plc, Wyeth and Forest Laboratories already have added a

precaution about risks to babies to the labels of their depression drugs,

Levin said. Glaxo sells Paxil and Forest sells Celexa and Lexapro. Generic

makers of fluvoxamine, another SSRI, also have added the information, Levin

said.

Eli Lilly has verbally committed to adding the information to Prozac's

label, and the FDA still is talking with Pfizer Inc. about Zoloft, Levin

said. Pfizer " supports the need to provide physicians with accurate

information " regarding antidepressant use during pregnancy, company

spokeswoman Shreya Prudlo said.

SSRIs boost the brain's use of the chemical serotonin. Effexor maximizes

levels of both serotonin and another brain chemical called norepinephrine.

(Additional reporting by Heavey in Washington)

[Guest guest]

Think of the unborn going through SSRI withdrawals......

Antidepressants to Come with Pregnancy Precaution

http://story.news./news?tmpl=story & cid=571 & ncid=1422 & e=4 & u=/nm/20040609\

/hl_nm/health_antidepressants_dc

Antidepressants to Come with Pregnancy Precaution

Wed Jun 9, 5:42 PM ET

By Richwine

ROCKVILLE, Md. (Reuters) - Drug makers are adding a notice to widely used

antidepressants that babies of women who take the drugs late in pregnancy

may experience jitteriness and other withdrawal symptoms, U.S. officials

said on Wednesday.

The Food and Drug Administration (news - web sites) urged the precaution in

light of scores of reports of withdrawal effects in newborns of women who

took certain antidepressants during the third trimester of pregnancy, agency

officials said.

The new information on drug labels urges physicians to carefully weigh

benefits and risks of antidepressant therapy in women during the late stages

of pregnancy, said Dr. Levin, a medical reviewer in the FDA's

division of neuropharmacological drug products.

Untreated depression poses serious risks for mother and baby, too, so

doctors should not automatically avoid giving the drugs during pregnancy,

FDA officials and members of an outside advisory panel emphasized.

One option is to consider tapering off depression drugs 10 to 14 days before

a mother's due date, Levin said.

Babies' withdrawal symptoms were reported after their mothers used drugs

such as Prozac and Zoloft that are known as selective serotonin reuptake

inhibitors, or SSRIs, as well as another antidepressant called Effexor made

by Wyeth .

Some of the most frequent withdrawal symptoms in infants included

jitteriness, tremors, breathing difficulties, and trouble sleeping. Effects

usually resolved on their own within days but in some cases required

extended hospital stays, insertion of feeding tubes or other treatment.

Long-term consequences are unknown, FDA officials and outside physicians

said.

" Clinicians need to be aware of the potential for these events, " Levin told

an FDA advisory committee.

An estimated 10 percent to 16 percent of pregnant women suffer from

depression, Levin said. Without treatment, serious depression can lead to

suicides, social isolation and malnutrition, a potential problem for

developing fetuses.

GlaxoKline Plc, Wyeth and Forest Laboratories already have added a

precaution about risks to babies to the labels of their depression drugs,

Levin said. Glaxo sells Paxil and Forest sells Celexa and Lexapro. Generic

makers of fluvoxamine, another SSRI, also have added the information, Levin

said.

Eli Lilly has verbally committed to adding the information to Prozac's

label, and the FDA still is talking with Pfizer Inc. about Zoloft, Levin

said. Pfizer " supports the need to provide physicians with accurate

information " regarding antidepressant use during pregnancy, company

spokeswoman Shreya Prudlo said.

SSRIs boost the brain's use of the chemical serotonin. Effexor maximizes

levels of both serotonin and another brain chemical called norepinephrine.

(Additional reporting by Heavey in Washington)