Lyrica No Better than Placebo at Treating Back Pain, Study Finds
March 24, 2017 – Lyrica is no better at treat sciatica nerve pain than a placebo, according to a study published Wednesday in the New England Journal of Medicine (NEJM). The researchers looked at 209 sciatica patients in Australia who took either Lyrica or a placebo, and found found no significant differences in leg pain intensity between the placebo group and patients treated with Lyrica, and no differences for other outcomes such as back pain, quality of life, and degree of disability.
What is Lyrica?
Lyrica belongs to the class of drugs called analgesics which are used to relieve pain caused by diabetic peripheral neuropathy (pain from damaged nerves due to diabetes) and postherpetic neuralgia (pain following healing of a rash due to shingles). The medication is also commonly used to relieve pain associated with fibromyalgia, and is useful in managing central neuropathic pain (pain from damaged nerves of the brain and spinal cord). Lyrica is made by Pfizer, and was approved by the U.S. Food & Drug Administration (FDA) in December 2004.
Lyrica Side Effects May Include “Major Birth Defects”, Study Finds
On May 18, 2016, a study published online in the journal Neurology found that women who take Lyrica during the first trimester of pregnancy may be 3 times more likely to give birth to a child with major congenital defects compared to women who did not take the drug. Lyrica was also linked to a decrease in live births due to abortions, some of which were considered medically necessary.
For the study, researchers looked at data on 164 women in 7 countries who took Lyrica during their first trimester, and compared the rate of birth defects and live births to 656 women who did not use the drug during pregnancy. Of the Lyrica users, 15 took it for neuropathic pain, 39 for psychiatric conditions, 5 for epilepsy, and 1 for restless leg syndrome (RLS).
The study found that Lyrica users had triple the risk of having a child with congenital defects including major heart malformations and central nervous system (CNS) abnormalities. When looking at the rate of CNS defects alone, the women were 6 times more likely to give birth to a baby with such conditions. The women who used Lyrica were also about 3 times as likely to terminate their pregnancy for medically necessary reasons.
Lyrica Pregnancy Warnings
The FDA classifies Lyrica as a pregnancy category C medication, meaning that animal studies have found increased incidences of fetal structural abnormalities and developmental toxicity including lethality, growth retardation, as well as both nervous and reproduction system impairment. Pregabalin may cross the placenta during pregnancy, and has been associated with reports of male-mediated teratogenicity. Lyrica should only be given during pregnancy when there are no alternatives and potential benefits outweigh the risks, according to the FDA.
Instructions for Men
Men who take Lyrica should be aware of the risk of male-mediated teratogenicity associated with the drug. Animal studies have found increased rates of skull alterations, skeletal malformations, decreased fetal body weights, and visceral variations. When offspring were tested as adults, neurobehavioral abnormalities and reproductive impairment were observed.
Do I Have a Lyrica Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Lyrica lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.
Free Confidential Case Evaluation: Again, if your child was injured by Lyrica side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.