Concerns have arisen from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, the FDA evaluated research studies published in the medical literature and determined these studies are too limited to make any recommendations based on them at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. The FDA urges pregnant women to always discuss all medicines with their health care professionals before using them.
Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. Medicines 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 the FDA reviewed reported on the potential risks associated with the following three types of pain medicines used during pregnancy. First, a study considered prescription NSAIDs and the risk of miscarriage in the first half of pregnancy. Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib. Ibuprofen and naproxen are also available OTC at lower strengths. They are used to relieve fever and pain, such as those associated with headaches, colds, flu, and arthritis. Findings from two U.S. studies indicate that approximately 18 to 25 percent of pregnancies are exposed to OTC ibuprofen and four percent of pregnancies are exposed to OTC naproxen. The FDA advises to avoid using nonsteroidal anti-inflammatory drugs (NSAIDs) in the third trimester of pregnancy because these drugs may cause a blood vessel in the fetus to close prematurely.
A second study considered 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. During each trimester of pregnancy, approximately six percent of pregnant women in the U.S. are exposed to opioids.
Finally, a study considered 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. Findings from two U.S. studies indicate that 65 to 70 percent of pregnant U.S. women reported using acetaminophen anytime during pregnancy.
The FDA found all of the studies it reviewed to have potential limitations in their designs. Some of the accumulated studies on a topic contained conflicting results that prevented the FDA from drawing reliable conclusions. As a result, the FDA recommendations on how pain medicines are used during pregnancy will remain the same at this time.
Pregnant women should always consult with their health care professional before taking any prescription or OTC medicine. Women taking pain medicines who are considering becoming pregnant should also consult with their health care professionals to discuss the risks and benefits of pain medicine use. Health care professionals should continue to follow the recommendations on the drug labels when prescribing pain medicines to pregnant patients.
See the FDA Announcement
See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability.
See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians.