The Food and Drug Administration (FDA) has issued a statement regarding the benefits and potential risks associated with the use of prescription and over-the-counter (OTC) pain medications during pregnancy in response to recent reports questioning their safety when used during pregnancy.
Published research on risks associated with specific pain drugs used during pregnancy was reviewed by the FDA, which included the following:
- Prescription NSAIDs and the risk of miscarriage in the first half of pregnancy
- Opioids and the risk of birth defects of the brain, spine, or spinal cord in babies born to women who took these products during the first trimester of pregnancy
- Acetaminophen (prescription and OTC) and the risk of attention deficit hyperactivity disorder (ADHD) in children born to women who took this medicine at any time during pregnancy
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Because of potential design limitations in all studies analyzed and conflicting results that prevented the drawing of reliable conclusions, the FDA’s recommendations on how pain medications are used during pregnancy will remain unchanged at this time. Healthcare professionals should continue to follow the recommendations in the drug labels when prescribing pain medications, both prescription and OTC, to pregnant patients.
For more information visit FDA.gov.