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drug_recall risperdalRisperdal pregnancy risks are classified by the FDA as falling under the Pregnancy Category C. This means that the federal government does not have sufficient information to determine if Risperdal pregnancy risks outweigh the drug''s intended benefits in patients who are taking this atypical anti-psychotic medication while pregnant or breastfeeding.
A Pregnancy Category C label may mean that animal clinical studies have shown harmful side effects in response to a particular dose administration, but that clinical findings on these risks in pregnant women are insufficient or inconclusive.
In animal trials Risperdal pregnancy risks were shown to cause an increased risk for newborn death in the first four days of life, an increased risk for stillborn births in rat pups, and a decrease in birth weight for some animal newborns. Risperdal has been shown to transfer through the placental to a developing fetus in animal studies. Animal studies have also shown that Risperdal is transmitted through breast milk.
Because Risperdal pregnancy animal studies have shown that this drug can transfer to a child during breastfeeding, women are urged not to take Risperdal if they are, or plan to, breastfeed. The effects of Risperdal on labor and delivery have also not been sufficiently studied in human populations.
Because so much is unknown about Risperdal pregnancy risks, it is important that women who are, or who plan to become pregnant or women who are breastfeeding discuss the Risperdal pregnancy risks with a medical professional. Determining whether Risperdal pregnancy risks outweigh this drug''s intended benefits is up to the discretion of a patient and her doctor.
There has been one case where human Risperdal pregnancy complications caused injury to a newborn child. In this case the human child was born with a brain defect; the corpus callosum was not fully developed in the child at birth. The corpus callosum is responsible for connecting the two hemispheres of the brain so that they are able to communicate with one another. This is the only known reported case of Risperdal pregnancy injuries in the human population.
Because Risperdal pregnancy risks in human patients is not fully understood it is important for Risperdal users to discuss pregnancy and breastfeeding with their doctor prior to deciding if Risperdal is safe for use.
Janssen Pharmaceutic Products, the makers of the anti-psychotic drug Risperdal, sent a letter to the health care community outlining the potential health risks associated with the medication.
This action is in compliance with the FDA''s re...
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