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Effects
of SSRIs and venlafaxine during pregnancy in term and pre-term neonates
National
Treatment Agency publishes review of effectiveness of treatments for alcohol
problems
Effects
of SSRIs and Venlafaxine during pregnancy in term and pre-term neonates
Source:
Data from a Canadian retrospective cohort study on the effects of SSRIs and
venlafaxine during pregnancy in term and pre-term neonates have been published
in Pediatrics.
The study included 76 mothers taking these drugs during the third trimester and
90 not on any antidepressants, psychotropic agents, or benzodiazepines at the
time of delivery of their newborns. The following findings were reported:
• In the cohort of exposed infants, the median gestational age was lower
compared to unexposed infants (38.3 weeks vs 39.7 weeks, p < 0.001).
• There was a higher rate of neonatal behavioural signs among infants exposed to
SSRIs or venlafaxine (77.6% vs 41.1%; p < 0.001) compared with unexposed infants.
• Neonatal behavioural signs in the exposed group included central nervous
(63.2%: tremors, shaking, agitation, spasms, hyper or hypotonia, irritability,
and sleep disturbances) and respiratory (40.8%: indrawing, apnoea/bradycardia,
and tachypnoea) systems.
• There were higher rates of vomiting, tachycardia, and jaundice in the exposed
group.
• All neonatal signs appeared during the first day of life; the median duration
was 3 days for newborns exposed to SSRIs or venlafaxine. In exposed infants, 75%
of these signs resolved after the fifth day for premature newborns (third day
for term newborns) compared with 3 days for unexposed premature infants (2 days
for term unexposed newborns).
• The adjusted odds ratios for effect of late exposure to SSRIs or venlafaxine
and prematurity on neonatal behavioural signs were 3.1 (1.3–7.1) and 8.0
(1.4–44.6), respectively.
• The rate of prematurity was higher in the exposed group, 21 (27.6%) vs 8
(8.9%; p = 0.003), this link disappeared when adjustment was made for
confounding variables.
• The median length of stay was 3.9 days for exposed newborns vs 2.4 days for
unexposed newborns (p < 0.001).
• Advanced maternal age and smoking were significantly associated with an
increased risk of neonatal behavioural signs
The study concluded that “neonatal behavioural signs were frequently found in
exposed newborns, but symptoms were transient and self-limited. Premature
infants could be more susceptible to the effects of SSRIs and venlafaxine.”
Link: http://pediatrics.aappublications.org/cgi/content/abstract/119/1/52
Source:
FDA MedWatch Safety Alert
Wyeth is alerting healthcare professionals about the
risk of fatal overdoses occurring in patients taking
Effexor and Effexor XR. Effexor (venlafaxine HCl) is an
SNRI used to treat major depressive disorder.
Wyeth's letter says that patients who overdose on
Effexor may have a higher risk of death than patients
who overdose on SSRIs, but a lower risk of death than
those who overdose with tricyclic antidepressants. It is
not clear whether this is due to the toxicity of Effexor
in overdose or the characteristics of patients who are
treated with this drug.
The company points out that the reported overdoses
usually occurred in combination with alcohol or other
drugs. Several of the most common events associated with
overdose include:
• Tachycardia
• Changes in level of consciousness
• Seizures
• Mydriasis
• Vomiting
Other events reported in patients who overdosed included
rhabdomyolysis, liver necrosis, serotonin syndrome and
death.
To reduce the risk of overdose, the company says that
healthcare professionals should prescribe Effexor and
Effexor XR in the smallest quantity that is consistent
with good patient management.
Additional Information:
FDA MedWatch Safety Alert. Effexor XR (venlafaxine
HCl) and Effexor (venlafaxine HCl) Tablets
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Effexor
Link:
http://www.accessdata.fda.gov/psn/transcript.cfm?show=59#4
Boletín de Actualización en Neuropsicofarmacología (BAN)
