Savella Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments:
-Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization.
-Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome (e.g.,. respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo/hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).
Animal studies have revealed evidence of minor skeletal variation, decreased body weight, and embryo-fetal, perinatal, and postnatal lethality. There are no adequate or well-controlled studies in pregnant women.
To monitor the outcomes of pregnant women exposed to this drug, a Savella (R) Pregnancy Registry has been established. Physicians are encouraged to register their patients and pregnant women are encouraged to register themselves by contacting [email protected]. For additional information: www.savellapregnancyregistry.com
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
