Lyrica (pregabalin) is an anti-epileptic medication, also called an anticonvulsant. It is used to treat pain caused by nerve damage due to diabetes or shingles (herpes zoster) infection, and is commonly prescribed to patients with epilepsy, fibromyalgia and generalized anxiety disorder (GAD).
The drug works by slowing down impulses in the brain that cause seizures, and affects chemicals in the brain that send pain signals across the central nervous system. Lyrica is made by Pfizer, and was first approved by the U.S. Food & Drug Administration (FDA) in December 2004.
What’s the Problem?
A study published in the journal Neurology on May 18, 2016, looked at pregnancy outcomes following the maternal use of Lyrica. The researchers collected data in 7 countries from 164 pregnant women who took Lyrica and a control group of 656 expecting mothers who did not use the drug. They found that Lyrica users were 3 times more likely to give birth to babies with major congenital defects compared to women in the control group. Specifically, 6% of pregnancies that involved the use of Lyrica resulted in defects, compared to 2% in women who didn’t take the drug.
Malformations associated with Lyrica included heart defects and structural problems with the central nervous system (CNS) or other organs. Women who took the drug were 6 times more likely to have a pregnancy that resulted in a major nervous system defect, according to the study.
“The significant increase in the rate of malformations observed in this study presently implies that pregabalin prescription be avoided whenever possible during pregnancy,” said Ursula Winterfeld, lead author of the study. “In patients of childbearing age, effective contraception should be advised when prescribing pregabalin, and its indication must be carefully re-examined in cases of desired or established unexpected pregnancy.”
Lyrica Side Effects
In addition to being linked to birth defects in babies born to mothers who take the drug in pregnancy, Lyrica may cause the following side effects in some users:
- Blistering, peeling, or loosening of the skin
- Difficulty with swallowing
- Fast heartbeat
- Joint or muscle pain
- Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- Red skin lesions, often with a purple center
- Red, irritated eyes
- Skin rash
- Sore throat
- Sores, ulcers, or white spots in the mouth or on the lips
- Unusual tiredness or weakness
- And more
FDA Warns of Breathing Problems With Lyrica
Dec. 23, 2019 – FDA on Thursday warned that Lyrica and other nervous system drugs may cause serious breathing problems when combined with opiods or other medications. The agency said it was requiring new warnings on the labeling of these drugs concerning the issue, urging physicians to avoid prescribing them in combination with other medications that can slow breathing, including opioid painkillers. These breathing risks also apply to elderly patients, and those with existing lung problems, FDA said.
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.
Pfizer Hit With $43 Million Settlement for Misleading Marketing of Lyrica
In December 2012, the attorneys general of 33 states and the District of Columbia reached a $43 million settlement with Pfizer over allegations that the company ignored FDA warnings and made false marketing claims about Lyrica and Zyvox, according to the Consumerist. In regards to Lyrica, the attorneys general took issue with Pfizer’s continued off-label marketing of the drug, which was originally approved to treat diabetic peripheral neuropathy and post-herpetic peripheral neuropathy, and later approved for fibromyalgia.
The company was also accused of encouraging its sales force to promote Lyrica as superior to its own Neurontin and its generic equivalent, gabapentin. The complaint alleged that Pfizer used incentive plans to motivate its sales force to encourage physicians to convert patients from taking Neurontin to Lyrica.
Do I Have a Lyrica Lawsuit?
The Pharmaceutical 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 defect cases in all 50 states.
Again, if you believe 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.