FDA - Antipsychotics Warning - Treatment During Pregnancy and Potential Risk to Newborns

[Guest guest]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244175.htm

Antipsychotic drugs: Class

Labeling Change - Treatment During Pregnancy and Potential Risk to

Newborns

including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa,

Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap,

Saphris, Stelazine, Thorazine, Symbyax

[Posted 02/22/2011]

AUDIENCE: Psychiatry, OBGYN

ISSUE: FDA notified healthcare

professionals that the Pregnancy section of drug labels for the

entire class of antipsychotic drugs has been updated. The new drug

labels now contain more and consistent information about the

potential risk for abnormal muscle movements (extrapyramidal signs

or EPS) and withdrawal symptoms in newborns whose mothers were

treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include

agitation, abnormally increased or decreased muscle tone, tremor,

sleepiness, severe difficulty breathing, and difficulty in

feeding. In some newborns, the symptoms subside within hours or

days and do not require specific treatment; other newborns may

require longer hospital stays.

BACKGROUND: Antipsychotic drugs

are used to treat symptoms of psychiatric disorders such as

schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare

professionals should be aware of the effects of antipsychotic

medications on newborns when the medications are used during

pregnancy. Patients should not stop taking these medications if

they become pregnant without talking to their healthcare

professional, as abruptly stopping antipsychotic medications can

cause significant complications for treatment.

Healthcare professionals and patients are encouraged to report

adverse events or side effects related to the use of these

products to the FDA's MedWatch Safety Information and Adverse

Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1

Download

form2

or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or

submit by fax to 1-800-FDA-0178

[02/22/2011 - Drug

Safety Communication3 - FDA]

[Guest guest]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244175.htm

Antipsychotic drugs: Class

Labeling Change - Treatment During Pregnancy and Potential Risk to

Newborns

including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa,

Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap,

Saphris, Stelazine, Thorazine, Symbyax

[Posted 02/22/2011]

AUDIENCE: Psychiatry, OBGYN

ISSUE: FDA notified healthcare

professionals that the Pregnancy section of drug labels for the

entire class of antipsychotic drugs has been updated. The new drug

labels now contain more and consistent information about the

potential risk for abnormal muscle movements (extrapyramidal signs

or EPS) and withdrawal symptoms in newborns whose mothers were

treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include

agitation, abnormally increased or decreased muscle tone, tremor,

sleepiness, severe difficulty breathing, and difficulty in

feeding. In some newborns, the symptoms subside within hours or

days and do not require specific treatment; other newborns may

require longer hospital stays.

BACKGROUND: Antipsychotic drugs

are used to treat symptoms of psychiatric disorders such as

schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare

professionals should be aware of the effects of antipsychotic

medications on newborns when the medications are used during

pregnancy. Patients should not stop taking these medications if

they become pregnant without talking to their healthcare

professional, as abruptly stopping antipsychotic medications can

cause significant complications for treatment.

Healthcare professionals and patients are encouraged to report

adverse events or side effects related to the use of these

products to the FDA's MedWatch Safety Information and Adverse

Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1

Download

form2

or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or

submit by fax to 1-800-FDA-0178

[02/22/2011 - Drug

Safety Communication3 - FDA]

[Guest guest]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244175.htm

Antipsychotic drugs: Class

Labeling Change - Treatment During Pregnancy and Potential Risk to

Newborns

including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa,

Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap,

Saphris, Stelazine, Thorazine, Symbyax

[Posted 02/22/2011]

AUDIENCE: Psychiatry, OBGYN

ISSUE: FDA notified healthcare

professionals that the Pregnancy section of drug labels for the

entire class of antipsychotic drugs has been updated. The new drug

labels now contain more and consistent information about the

potential risk for abnormal muscle movements (extrapyramidal signs

or EPS) and withdrawal symptoms in newborns whose mothers were

treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include

agitation, abnormally increased or decreased muscle tone, tremor,

sleepiness, severe difficulty breathing, and difficulty in

feeding. In some newborns, the symptoms subside within hours or

days and do not require specific treatment; other newborns may

require longer hospital stays.

BACKGROUND: Antipsychotic drugs

are used to treat symptoms of psychiatric disorders such as

schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare

professionals should be aware of the effects of antipsychotic

medications on newborns when the medications are used during

pregnancy. Patients should not stop taking these medications if

they become pregnant without talking to their healthcare

professional, as abruptly stopping antipsychotic medications can

cause significant complications for treatment.

Healthcare professionals and patients are encouraged to report

adverse events or side effects related to the use of these

products to the FDA's MedWatch Safety Information and Adverse

Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1

Download

form2

or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or

submit by fax to 1-800-FDA-0178

[02/22/2011 - Drug

Safety Communication3 - FDA]

[Guest guest]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244175.htm

Antipsychotic drugs: Class

Labeling Change - Treatment During Pregnancy and Potential Risk to

Newborns

including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa,

Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap,

Saphris, Stelazine, Thorazine, Symbyax

[Posted 02/22/2011]

AUDIENCE: Psychiatry, OBGYN

ISSUE: FDA notified healthcare

professionals that the Pregnancy section of drug labels for the

entire class of antipsychotic drugs has been updated. The new drug

labels now contain more and consistent information about the

potential risk for abnormal muscle movements (extrapyramidal signs

or EPS) and withdrawal symptoms in newborns whose mothers were

treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include

agitation, abnormally increased or decreased muscle tone, tremor,

sleepiness, severe difficulty breathing, and difficulty in

feeding. In some newborns, the symptoms subside within hours or

days and do not require specific treatment; other newborns may

require longer hospital stays.

BACKGROUND: Antipsychotic drugs

are used to treat symptoms of psychiatric disorders such as

schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare

professionals should be aware of the effects of antipsychotic

medications on newborns when the medications are used during

pregnancy. Patients should not stop taking these medications if

they become pregnant without talking to their healthcare

professional, as abruptly stopping antipsychotic medications can

cause significant complications for treatment.

Healthcare professionals and patients are encouraged to report

adverse events or side effects related to the use of these

products to the FDA's MedWatch Safety Information and Adverse

Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1

Download

form2

or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or

submit by fax to 1-800-FDA-0178

[02/22/2011 - Drug

Safety Communication3 - FDA]