Hi, friends welcome to the channel- The Nurse.
Here we are discussing FDA Pregnancy Risk
Drug Classifications.
Food & Drug Administration (FDA) Pregnancy
Risk Categories
 Each drug may be placed in a pregnancy
risk category based on the FDA’s estimate
of risk to the fetus
 
The categories range from A to X, signifying
least to greatest fetal Risk
Category – A (Controlled studies show no
risk)
Adequate, well-controlled studies with pregnant
women have failed to demonstrate a risk to
the fetus in any trimester of pregnancy
Category – 
B (No Evidence of risk in humans)
 Adequate, well-controlled studies with
pregnant women haven’t shown an increased
risk of fetal abnormalities, or, in the absence
of adequate human studies, animal studies
show no fetal risk.
 The chance of fetal harm is remote
but remains possible
Category –
C (Risk Can’t be Ruled Out)
 Adequate, Well-controlled human studies
are lacking, and animal studies have shown
a risk to the fetus or are lacking as well
 A chance of fetal harm exists if the drug
is given during pregnancy, but the potential
benefits may outweigh
the risk.
Category – D (Positive Evidence of Risk)
 Studies in humans, or investigational
or post-marketing data, have shown fetal risk
 Nevertheless, potential benefits from
the drug’s use may outweigh risks
 For example, the drug may be acceptable
if
needed in a life-threatening situation or
serious disease for which safer drugs can’t
be used or are ineffective
Category – X (contraindicated in pregnancy)
Studies in animal or humans, or investigational
or post-marketing reports, have shown positive
evidence of fetal abnormalities or risks that
clearly outweigh any possible benefits to
the patient.
Please find out the FDA Pregnancy Risk categories
of following drugs (Write in the Comment Box)
• Atorvastatin
• Levothyroxine
• Gabapentin
• Losartan
• Metformin
The video ends here, thank you for watching
this video.
Please Like and Share This Video &
Don’t forget to Subscribe Our channel – The
Nurse
Thank You
