The popular and widely-prescribed drug Lyrica® (pregabalin), may slightly raise risks for major birth defects, according to a new study published in Neurology (May 18th), the online medical journal of the American Academy of Neurology (AAN). Experts involved in the study are now warning that expectant mothers should avoid the drug if possible – though the study has yet to prove a definitive cause and effect.
Lyrica, a drug manufactured by Pfizer, Inc., is approved by the U.S. Food and Drug Administration (FDA) to treat fibromyalgia, epilepsy, and neuropathic pain (like that of diabetic neuropathy or pain from shingles or a spinal cord injury). The drug is also prescribed by doctors “off-label” to help certain patients with anxiety, depression, and other mental health issues.
Interpreting the Study’s Findings
Dr. Thierry Buclin, the senior author of the study, said, “These results should be taken with caution. It’s a warning, but it cannot be taken as a certainty.” As with most small studies, Buclin did note its limitations: “We should not unduly alarm mothers-to-be about a definite risk. This is just a signal, a warning that there might be a problem with Lyrica.”
In retort, a spokesman for Pfizer Inc., Steven Danehy, stated that “the study has significant limitations and cannot be used to draw definitive conclusions…. The women [in the study] taking Lyrica had higher rates of smoking and diabetes, all of which can negatively affect pregnancy outcomes.”
Meanwhile Pfizer’s Lyrica has gone on to become one of the prescription drug market’s true blockbusters, bringing in over $2.3 Billion in sales to the world’s 2nd largest pharmaceutical company. Currently, the drug is listed on Medical Daily’s Top 25 most-popular prescription drugs at number 17, and is the highest-selling drug for fibromyalgia.
What the Study Yielded
In the study, 164 women who took Lyrica during their first trimester of pregnancy were compared against a control group of 656 pregnant women who were not taking Lyrica. In the group of Lyrica users, 115 women used the drug to treat neuropathic pain, 39 took it for depression, anxiety, bipolar disorder or psychosis, 5 for epilepsy, and 1 for restless leg syndrome.
In the study, researchers noted that out of women who were taking Lyrica during the first trimester of their pregnancy, 6 percent had infants with major birth defects. Out of women who weren’t taking Lyrica, only 2 percent gave birth to children with major birth defects.
The Birth Defects Linked to Using Lyrica®
According to the data that the researchers gathered, women taking Lyrica had a 6-times greater chance of having a baby with a major defect in the central nervous system than women who were not taking the drug.
These birth defects included serious heart problems and problems with the infant’s central nervous system or other organs. One of the researchers and coauthors of the Neurology article, Dr. Page Pennell of Harvard Medical School, said, “the risk of birth defects is probably higher with Lyrica.… This is probably the best information we are going to get, and there is a signal of concern here.”
Mothers-to-Be Should Know
To help mitigate the chances of incurring such defects, Pennell and Buclin both recommend a planned pregnancy. Anti-seizure medications – like Lyrica – have been linked to birth defects before, so it’s important weigh the benefits of a planned pregnancy. Pennell said, “If you have a planned pregnancy, it gives the woman a chance to discuss with her doctor the pros and cons of staying on a medication.”
Generally, based on the results of this study, doctors like Buclin are recommending that women do not take Lyrica if pregnant or planning to become pregnant. If a pregnant woman has no choice but to take Lyrica during pregnancy, Pennell advises that these particular patients be monitored by their doctors very carefully.
