Pregnant women who take pregabalin — or Pfizer’s Lyrica — may increase the risk of having babies with major birth defects.
A team of researchers initiated a new study, supported by the American Academy of Neurology. The team investigated the pain and anti-seizure drug, Lyrica. The researchers concluded that taking pregabalin, or Lyrica, during the first trimester of pregnancy may increase the risk of major birth defects.
Lyrica is Pfizer’s trade name for a drug called pregabalin. Lyrica is one of Pfizer’s top selling drugs — bringing in more than $3.6 billion last year.
Pregabalin is often used to treat neuropathic pain, as well as partial seizures that are common in temporal lobe epilepsy. In Europe, pregabalin is also approved to treat generalized anxiety disorder.
Pregabalin (Lyrica) usage
Lyrica has been approved in the United States to treat diabetic neuropathy pain, epilepsy, and postherpetic neuralgia (pain after shingles).
Lyrica is also used to relieve pain from damaged nerves that can occur in your arms, hands, fingers, legs, feet, or toes. It is used to treat fibromyalgia, as well.
In addition, pregabalin is used with other medications to treat certain types of seizures in people with epilepsy.
Pregabalin is prescribed mainly for pain and to help prevent seizures; however, it is also used in treating psychiatric disorders — including anxiety, bipolar disorder, psychosis, and depression.
Unfavorable study results for Pfizer’s Lyrica
This latest study on Pfizer’s Lyrica consisted of 164 pregnant women in seven countries.
A team of researchers initiated a multicenter, observational prospective cohort study and found that 15 percent of infants exposed to the drug Lyrica — or pregabalin — had major birth defects compared to 2.8 percent of those infants who were not exposed.
The researchers found that for women who took Lyrica during the first trimester, “major birth defects” were three times as likely than for the women who didn’t take the medication. The results were measured against a group of 656 pregnant women not taking similar drugs.
The major birth defects included eight structural problems and four chromosomal problems. The structures that were affected included the cardiac system, skeletal system, central nervous system, and the skin or vascular system.
Five neonatal complications were reported in 13 newborns that were exposed to pregabalin until delivery. Four babies were born with clavicle fracture, withdrawal syndrome, or isolated respiratory distress.
The fifth, whose mother took aspirin until 36 weeks followed by enoxaparin until 38 weeks — developed hypotonia, respiratory distress, and shock with hepatic cytolysis, renal insufficiency, and metabolic acidosis. Most unfortunately — the infant died at 6 weeks old.
Lead author of this new study, Ursula Winterfeld, PhD, of Lausanne University Hospital in Switzerland, and her colleagues reported their findings in the journal Neurology.
The research will need to be confirmed with larger tests. However, Dr. Winterfeld wrote that this latest study signals “that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy.”