Pain medications may be harmful to pregnant women or their babies

What are you supposed to do if you are pregnant and you are in significant pain? Should you take over the counter or prescription pain medications? Are they safe for your baby?

Before you take anything, it is important to talk with your doctor and to find out what the Federal Drug Administration (FDA) says about pain medicine.

The January 2015 FDA Safety Alert About Pain Medication During Pregnancy

On January 6, 2015, the FDA issued a safety alert to doctors and the public. In that alert, the FDA explained that it was aware of the concern about using pain medication during pregnancy, that it had evaluated recent studies on the subject, and that it concluded that the information was too limited to make specific recommendations about safety. Instead, the FDA urged pregnant women to:

  • Discuss their concerns and pain management options with their doctors.
  • Carefully weigh the potential benefits of using medication against the potential risks.

Additionally, health care professionals were encouraged to keep reporting adverse effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Of course, you should also report any adverse effects both to your doctor and, potentially, to a drug injury lawyer. Even though the FDA did not issue an official warning, drug manufacturing companies that fail to warn pregnant women about the potential risks associated with pain medications could be liable for the harm caused by these medications in some cases.

State Attorneys General Want the FDA to Take Further Action

In 2013, the National Association of Attorneys General asked the U.S. Food and Drug Administration (FDA) to put a black box warning on opioid pain relief medications. Specifically, the attorneys general from 43 states and territories asked the FDA to add a black box warning to inform pregnant women that these types of prescription pain relief drugs could negatively affect infants.

A black box warning is the strongest type of warning that the FDA can require. It is a text alert displayed prominently on the packaging or supplemental instructions for a prescription drug, warning consumers that there is a significant risk of serious complications with the medicine.

The primary concern raised by the attorneys general is the possibility of infants developing neonatal abstinence syndrome, or NAS. NAS occurs when infants are exposed to opioid pain medications during gestation and suffer withdrawal symptoms after birth. The symptoms of NAS may include:

  • Abnormal sleep patterns
  • Tremors
  • Vomiting
  • Seizures
  • Weight loss

Other complications may also occur. Accordingly, the attorneys general want women of childbearing age and their doctors or other healthcare providers to be aware of the risks, so that women seeking pain relief during pregnancy can make informed decisions.

Bottom Line: Talk to Your Doctor and Help Raise Awareness

It is important for you, and other pregnant women, to understand the potential risks before you take any medication during pregnancy. Accordingly, you should talk to your doctor about the potential pros and cons of possible pain medications before taking anything. Additionally, we encourage you to share this article on Facebook or Twitter to help raise awareness about the risk among other pregnant women, so that they too can make informed decisions.

Jason F. Abraham
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Helping car accident and personal injury victims throughout Wisconsin, Illinois and Iowa since 1993.