Pregabalin is a drug known by brand name Lyrica. It is approved in the U.S. to treat nerve pain, including fibromyalgia and pain caused by shingles and diabetes, as well as for seizures. Some physicians also are prescribing the drug for psychological conditions for which Lyrica is not FDA-approved to treat. This is called “off label” prescribing.
The results of a recent international prospective study have raised concern about this drug. The study associated Pregabalin use in mothers with an increased risk for major birth defects in their children.
The research was conducted by scientists including Dr. Ursula Winterfeld of Lausanne University Hospital in Switzerland. It was published here, in the medical journal, Neurology, the medical journal of the American Academy of Neurology. The study found that exposure to Pregabalin during pregnancy was associated with a three-fold increase in the risk for major birth defects.
Major birth defects seen in the studied children included chromosomal and structural problems. Structures that were affected in the babies included their central nervous systems (brain and spinal cord malformations), skeletal systems (bone and limb malformations), cardiac systems (heart malformations), skin, and vascular system injuries. Women who had taken the drug also had a lower live birth rate than those in a control group, who were not exposed to Lyrica.
The research team advised that Pregabalin should only be prescribed in women of childbearing age on a valid indication and after thorough risk-benefit analysis, including counseling about effective birth control. In patients exposed to Pregabalin during pregnancy, enhanced fetal monitoring also may be warranted. Researchers noted the importance of conducting further studies to confirm these concerning findings.
Contact Phillips & Paolicelli LLP to Learn More About Filing a BIRTH DEFECTS Lawsuit
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