Washington, DCIs Lyrica safe? It depends who you ask. Studies indicate the risk of birth defects is high, but Pfizer, the manufacturer, disagrees. And perhaps the benefits outweigh the risks for an epileptic patient. Maybe not so much for women taking the anticonvulsant drug off-label…
A study published earlier this year in Neurology found that women taking Lyrica were at “increased risk of major birth defects after first trimester exposure to pregabalin” (generic name for Lyrica). The researchers found that women who took the antiseizure med during the first trimester were three times more likely than women not taking Lyrica. They were six times more likely to have a baby born with CNS [central nervous system] defects.
According to FiercePharma , Pfizer said the Neurologystudy had “significant limitations," because it “was small, did not account for other medical conditions or medications, and the women taking Lyrica had higher rates of smoking and diabetes, all of which can negatively affect pregnancy outcomes.”
Lyrica was approved by the FDA to treat epilepsy, fibromyalgia and neuropathic pain, but it is also prescribed off-label to treat anxiety and other mental health issues. An epileptic seizure during pregnancy is dangerous for both mother and child, so for some women, Lyrica may be a necessary evil. But there are many alternatives for patients suffering with mental health problems. Surely for those women, Lyrica birth defect risks outweigh the benefits.
Regardless Pfizer’s response, given the study results it is likely that Lyrica lawsuits will follow. For instance, hundreds of Zofran birth defect lawsuits were filed after studies showed that women taking the anti-nausea drug had a significant risk of birth defects in their children.
In all likelihood Lyrica lawsuits will be a ‘drop in the bucket’ for Pfizer. Last year Lyrica brought in $3.6 billion. And the company is likely too busy suing UK doctors and pharmacists for prescribing generic pregabalin. FiercePharma reported that Pfizer sent letters to physicians, health service officials and pharmacists pointing out its 2017 Lyrica patent and promising to enforce it in court if necessary. But Judge Richard Arnold determined that the generic drug maker did not break the rules with Pfizer’s patent. If you ask Pfizer if Lyrica is safe, the answer is obvious.
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