jake
June 11th 04, 08:32 AM
SSRI Antidepressant Pregnancy Exposure Risks Should Be Communicated In
Patient Labeling, Subcmte. Says
http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Anti-In
fective+Drugs/060904_pediatric/060904_SSRIneonatalR.htm
Antidepressant pregnancy exposure risks should be described in patient
labeling, FDA's Pediatric Subcommittee of its Anti-Infective Drugs Advisory
Committee recommended June 9.
"The point here is we've all been talking about giving the information out
to the doctors, and that's important, but you also have to give it to the
mother. The mothers have to have this information given to them the best
that they can have," subcommittee member Judith O'Fallon, PhD, Mayo Clinic,
said.
The subcommittee said that the potential risks of prenatal exposure to
selective serotonin and norepinephrine reuptake inhibitors should be
communicated to patients even though a conclusive link to toxicity has not
be determined.
FDA has received reports of neurological, neuromuscular and autonomic
effects in newborns whose mothers were taking SSRI/SNRIs such as Prozac,
Paxil, Celexa, Effexor, Zoloft and Luvox.
The side effects of agitation, irritability, trouble feeding etc. could be
the sign of a withdrawal syndrome, FDA said.
The subcommittee recommended against the issuance of a public health
advisory by FDA for fear that it would unduly scare patients away from
depression therapy based on inconclusive information.
The subcommittee also supported physician education as a means of
communicating the potential risks to newborns from SSRI/SNRIs but
recommended against the issuance of a letter to health care providers due to
the intricacies of the risk/benefit consideration involved.
FDA is proposing class labeling for SSRI/SNRIs on prenatal exposure be added
to the pregnancy section.
The proposed precaution states: "Neonates exposed to SSRI/SNRI late in 3rd
trimester have developed AE requiring prolonged hospitalization, respiratory
support, tube feeding. AE may arise immediately upon delivery."
Adverse events that have been reported include respiratory distress,
cyanosis, apnea, seizures, temperature instability, feeding difficulty,
vomiting, hypoglycemia, hypertonia, hyperreflexia, tremor, jitteriness,
irritability, and constant crying, the precaution will state.
The dosage and administration section may also advise tapering SSRI/SNRI
treatment late in the 3rd trimester, FDA said.
To watch an archived webcast of this meeting, click the button below.
http://www.iian.ibeam.com/events/fdcr001/index.jsp?ei={29B22469-CAEE-440E-BC
9E-207A859B302F}
To order videotapes & DVDs, email or call
800-627-8171.
Posted: Wednesday, June 09,
Patient Labeling, Subcmte. Says
http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Anti-In
fective+Drugs/060904_pediatric/060904_SSRIneonatalR.htm
Antidepressant pregnancy exposure risks should be described in patient
labeling, FDA's Pediatric Subcommittee of its Anti-Infective Drugs Advisory
Committee recommended June 9.
"The point here is we've all been talking about giving the information out
to the doctors, and that's important, but you also have to give it to the
mother. The mothers have to have this information given to them the best
that they can have," subcommittee member Judith O'Fallon, PhD, Mayo Clinic,
said.
The subcommittee said that the potential risks of prenatal exposure to
selective serotonin and norepinephrine reuptake inhibitors should be
communicated to patients even though a conclusive link to toxicity has not
be determined.
FDA has received reports of neurological, neuromuscular and autonomic
effects in newborns whose mothers were taking SSRI/SNRIs such as Prozac,
Paxil, Celexa, Effexor, Zoloft and Luvox.
The side effects of agitation, irritability, trouble feeding etc. could be
the sign of a withdrawal syndrome, FDA said.
The subcommittee recommended against the issuance of a public health
advisory by FDA for fear that it would unduly scare patients away from
depression therapy based on inconclusive information.
The subcommittee also supported physician education as a means of
communicating the potential risks to newborns from SSRI/SNRIs but
recommended against the issuance of a letter to health care providers due to
the intricacies of the risk/benefit consideration involved.
FDA is proposing class labeling for SSRI/SNRIs on prenatal exposure be added
to the pregnancy section.
The proposed precaution states: "Neonates exposed to SSRI/SNRI late in 3rd
trimester have developed AE requiring prolonged hospitalization, respiratory
support, tube feeding. AE may arise immediately upon delivery."
Adverse events that have been reported include respiratory distress,
cyanosis, apnea, seizures, temperature instability, feeding difficulty,
vomiting, hypoglycemia, hypertonia, hyperreflexia, tremor, jitteriness,
irritability, and constant crying, the precaution will state.
The dosage and administration section may also advise tapering SSRI/SNRI
treatment late in the 3rd trimester, FDA said.
To watch an archived webcast of this meeting, click the button below.
http://www.iian.ibeam.com/events/fdcr001/index.jsp?ei={29B22469-CAEE-440E-BC
9E-207A859B302F}
To order videotapes & DVDs, email or call
800-627-8171.
Posted: Wednesday, June 09,