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SSRI Antidepressant Pregnancy Exposure Risks Should Be Communicated In Patient Labeling, Subcmte. Says

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. To order videotapes & DVDs, email or call 800-627-8171.
Posted: Wednesday, June 09, 2004

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This meeting will be held June 9, 2004 at the CDER Advisory Committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8 a.m.
    Draft Agenda     Briefing Documents     Pediatric Subcommittee Information    

  • Pediatric Subcommittee To Consider Neonatal Antidepressant Withdrawal June 9   [Posted: 6/8/04]
  • SSRI Antidepressant Effects On Infants Will Be Discussed At June 9 Pediatric Subcmte.   [Posted: 4/22/04]

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