Women who suffer with chronic pain or anxiety and take pregabalin or Lyrica (as it’s more commonly known) may want to think twice. A new study, published in the journal Neurology, suggests that the use of Lyrica during pregnancy may raise the risk of birth defects.
The study involved data collected from 164 women across seven countries who took pregabalin during their pregnancy as well as from 656 pregnant women who did not take the anti-seizure medication during their pregnancy. After the women gave birth, the researchers collected data on their offspring.
Used to treat epilepsy, fibromyalgia and neuropathic pain, pregabalin is also often prescribed off label for generalized anxiety disorder and some other mental health conditions. Among the women in the study, many of them took the drug for neuropathic pain, with a smaller number took it for psychiatric disorders such as depression, anxiety, bipolar disorder and psychoses. Only five of the women were taking it for epilepsy. Seventy-seven percent started the drug before their pregnancy and all had stopped taking by the six-week gestation mark. It should be noted that thirteen percent of the women on Lyrica were also taking a second anti-seizure drug.
An analysis showed that pregnant women who took pregabalin during the first trimester of pregnancy were three times more likely to have a child with major birth defects compared to those who didn’t. Major birth defects included heart defects and structural problems with organs or the CNS (central nervous system). In fact, the women who took pregabalin had a six percent chance of having a birth defect of the central nervous system while women who didn’t take the drug only had a much smaller risk of half of a percent.
Lead researcher Ursula Winterfeld of Lausanne University Hospital in Lausanne, Switzerland, acknowledges that the study was small and that a larger study would be needed to confirm the results. In the meantime, she suggests that women who are taking the drug and plan on getting pregnant should discuss with their doctor whether the benefits outweigh the risks. She also stipulated that, based on the study, women taking Lyrica should use birth control. And should an intended or unintended pregnancy occur, extra fetal monitoring can be an option.
Understanding drugs and birth defects
As a guideline, the FDA has created five categories to help patients gauge the risk of a drug causing potential birth defects during pregnancy. These include:
- Drugs that don’t appear to pose any dangerduring the first trimester or any trimester of pregnancy fall into category A.
- Drugs that appear safe to use these drugs during pregnancy, though direct studies involving pregnant women is still lacking. Such drugs fall into category B.
- Drugs in which animal studies suggest possible adverse effects on the fetus fall into category C.
- With drugs in category D, evidence of positive fetal risk based on investigational studies and/or marketing experience has been documented.
- Drugs that have positive evidence of human fetal risk carry the most risk and fall into category X.
If you are considering getting pregnant, or find yourself pregnant, immediately discuss the use of all medications with your health care provider.
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Amy Hendel, also known as The HealthGal, is a Physician Assistant, nutritionist and fitness expert.As a health media personality, she's been reporting and blogging on lifestyle issues and health news for over 20 years. Author of The 4 Habits of Healthy Families, her website offers daily health reports, links to her blogs, and a library of lifestyle video segments.