FDA defers to docs in use of pain therapies for pregnant women

January 12, 2015

In a drug safety communication, FDA said that it is aware of recent reports questioning the safety of prescription and over-the-counter (OTC) pain drugs when used during pregnancy, but that it lacks adequate studies to change current recommendations.

In a drug safety communication, FDA said that it is aware of recent reports questioning the safety of prescription and over-the-counter (OTC) pain drugs when used during pregnancy, but that it lacks adequate studies to change current recommendations.

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Because of this uncertainty, use of pain medicines during pregnancy should be carefully considered. “We urge pregnant women to always discuss all medicines with their healthcare professionals before using them,” said FDA. 

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Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. Drugs, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. However, it is important to carefully weigh the benefits and risks of using prescription and OTC pain medicines during pregnancy.

The published studies FDA reviewed reported on the potential risks associated with the following 3 types of pain medicines used during pregnancy:

·       Prescription NSAIDs (ibuprofen, naproxen, diclofenac, and celecoxib) and the risk of miscarriage in the first half of pregnancy.

·       Opioids (oxycodone, hydrocodone, hydromorphone, morphine, and codeine), which are available only by prescription, 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 in both OTC and prescription products and the risk of attention deficit hyperactivity disorder (ADHD) in children born to women who took this medicine at any time during pregnancy. Acetaminophen is a common pain reducer and fever reducer found in hundreds of medicines including those used for colds, flu, allergies, and sleep. 

As a result of FDA’s decision, some key questions remain, according to John Santilli, partner, Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries:

·      Will the physician’s recommendation on pain medication remain the same?

·      Are pregnant women at risk of under treatment, or no treatment, for pain during pregnancy?

·      A study in Anesthesiology showed that more than 14% of American women take pain medications during pregnancy. Will this percentage change as a result of FDA’s inaction?