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FDA Reviews Possible Risks of Pain Medications During Pregnancy

Agency finds conflicting study data

In a recent statement, the FDA has announced that it is aware of recent reports questioning the safety of prescription and over-the-counter (OTC) pain medications when used during pregnancy. As a result, the agency evaluated research studies published in the medical literature and determined that they are too limited to make recommendations based on these studies at this time.

Because of this uncertainty, the use of pain medications during pregnancy should be carefully considered, the agency says.

Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and hypertension in the mother. Medications, 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 FDA reviewed published studies on the potential risks associated with the following three types of pain medications used during pregnancy:

  • Prescription NSAIDs and the risk of miscarriage in the first half of pregnancy. Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.
  • Opioids, 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. Examples of opioids include oxycodone, hydrocodone, hydromorphone, morphine, and codeine.
  • 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.

The FDA found that all of the studies it reviewed had potential limitations in their designs; sometimes the accumulated studies on a topic contained conflicting results that prevented the agency from drawing reliable conclusions. As a result, its recommendations on how pain medicines are used during pregnancy will remain the same at this time.

Health care professionals should continue to follow the recommendations in the drug labels when prescribing pain medications to pregnant patients.

The FDA says it will continue to monitor and evaluate the use of pain medications during pregnancy and will issue updates as new safety information becomes available.

Source; FDA; February 9, 2015.

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